Website References

All the data and information provided on our website has been properly sourced and referenced. This page includes all the references and sources we used to write our articles in alphabetical order. You may consult them all here.

 

Abilify

  1. Shayna Posses (June 27, 2016). Send Abilify Compulsive Gambling Suits To Fla.: Consumers. Law360.
  2. Miley et al v. Bristol-Myers Squibb Company et al
  3. United States Judicial Panel on Multidistrict Litigation. IN RE: Abilify® (Aripiprazole) Products Liability Litigation, MDL No. 2734
  4. United States Judicial Panel on Multidistrict Litigation. Report Date: 11/15/2016. MDL Statistics Report – Distribution of Pending MDL Dockets by District. (Accessed November 2016)
  5. U.S. Food and Drug Administration (FDA). May 5, 2016. Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication – FDA Warns About New Impulse-control Problems. (Accessed October 2016)

Actemra

  1. Charles Piller, June 5, 2017. Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients. STAT. Retrieved from: https://www.statnews.com/2017/06/05/actemra-rheumatoid-arthritis-fda/ (Accessed July 2017)
  2. Okuda Y. Review of tocilizumab in the treatment of rheumatoid arthritis. Biologics : Targets & Therapy. 2008;2(1):75-82.
  3. Tansey EM, Catterall PP. “Monoclonal antibodies: a witness seminar in contemporary medical history”. Med Hist. 38 (3): 322–7. PMC 1036884
  4. Keown, A., (07 June 2017), Hundreds of Deaths Linked to Actemra, Pharmalive. Retrieved from: http://www.pharmalive.com/hundreds-of-patient-deaths-linked-to-roches-ra-drug-actemra/ (Accessed July 2017)
  5. Nishimoto N, et al. Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Annals of the Rheumatic Diseases. 2009;68(10):1580-1584. doi:10.1136/ard.2008.092866.

Alere INRatio

  1. U.S. Food and Drug Administration (FDA). Alere Initiates Voluntary URGENT CORRECTION for Use of Alere INRatio® and INRatio®2 PT/INR Monitor System. www.fda.gov (Accessed July 2016).
  2. U.S. Food and Drug Administration (FDA). Alere San Diego Inc., Alere INRatio and INRatio2 PT/INR Monitor System (Professional and Prescription Home Use) – Falsely Low INR Test Results. www.fda.gov (Accessed August 2016).
  3. Gardiner, C., Williams, K., Mackie, I.J., Machin, S.J., Cohen, H. (2005). Patient self-testing is a reliable and acceptable alternative to laboratory INR monitoring. Br J Haematol 128, 242–247.
  4. Piazza, G., Nguyen, T. N., Cios, D., Labreche, M., Hohlfelder, B., Fanikos, J., Fiumara, K., Goldhaber, S. Z. (2011). Anticoagulation-associated adverse drug events. The American Journal of Medicine, 124 (12), 1136–1142.
  5. Heneghan C, Ward A, Perera R, et al. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet. 2012;379:322-334.
  6. Fritsma, George A. (2002). “Evaluation of Hemostasis.” Hematology: Clinical Principles and Applications . Ed. Bernadette Rodak. W.B. Saunders Company: Philadelphia, 2002. 719-53. Print

Benicar

  1. Benicar® Full Prescribing Information. (Accessed January 2016)
  2. Izzo JL Jr, Neutel JM, Silfani T, Dubiel R, Walker F. Efficacy and safety of treating stage 2 systolic hypertension with olmesartan and olmesartan/HCTZ: results of an open-label titration study. J Clin Hypertens (Greenwich). 2007;9;36-44
  3. U.S. Food and Drugs Administration (FDA). Olmesartan (marketed as Benicar) Information. (Accessed January 2016).
  4. U.S. Food and Drugs Administration (FDA). FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil. (Accessed January 2016).
  5. De Petris G, Caldero SG, Chen L, et al. (May 2014). “Histopathological changes in the gastrointestinal tract due to medications: an update for the surgical pathologist (part II of II)”. Int. J. Surg. Pathol. 22 (3): 202–11.doi:10.1177/1066896913502230
  6. Rubio-Tapia A, Herman ML, Ludvigsson JF, et al. Severe spruelike enteropathy associated with olmesartan. Mayo Clin Proc 2012;87:732-8.
  7. DeGaetani M, Tennyson CA, Lebwohl B, et al. Villous atrophy and negative celiac serology: A diagnostic and therapeutic dilemma. Am J Gastroenterol 2013;108:647-53.
  8. Agenzia Italiana del Farmaco (AIFA). Olmesartan – Riassunto delle caratteristiche del prodotto. (Accessed January 2016)
  9. Sanford ML, Nagel AK. A Review of Current Evidence of Olmesartan Medoxomil Mimicking Symptoms of Celiac Disease. J Pharm Pract. 2014 Mar 28.
  10. Marietta, E. V., Nadeau, A. M., Cartee, A. K., Singh, I., Rishi, A., Choung, R. S., Wu, T.-T., Rubio-Tapia, A. and Murray, J. A. (2015), Immunopathogenesis of olmesartan-associated enteropathy. Alimentary Pharmacology & Therapeutics, 42: 1303–1314. doi: 10.1111/apt.13413
  11. Hünseler, C; Paneitz, A; Friedrich, D; Lindner, U; Oberthuer, A; Körber, F; Schmitt, K; Welzing, L; Müller, A; Herkenrath, P; Hoppe, B; Gortner, L; Roth, B; Kattner, E; Schaible, T (Jan 2011). “Angiotensin II receptor blocker induced fetopathy: 7 cases”. Klin Padiatr 223 (1): 10–4. doi:1055/s-0030-1269895
  12. Yasuhiko Sakata, Nobuyuki Shiba, et al.Clinical impacts of additive use of olmesartan in hypertensive patients with chronic heart failure: the supplemental benefit of an angiotensin receptor blocker in hypertensive patients with stable heart failure using olmesartan (SUPPORT) trial. European Heart Journal Apr 2015, 36 (15) 915-923; DOI: 10.1093/eurheartj/ehu504
  13. Imai E, Chan JC, Ito S, et al. Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study. Diabetologia 2011; 54: 2978-86.
  14. Zhou EH, Gelperin K, Levenson MS, et al. Risk of acute myocardial infarction, stroke, or death in patients initiating olmesartan or other angiotensin receptor blockers – a cohort study using the Clinical Practice Research Datalink. Pharmacepidemiol Drug Saf 2014; 23: 340-7.
  15. S. Food and Drugs Administration (FDA). DEPARTMENT OF HEALTH & HUMAN SERVICES – Daiichi Sankyo Warning Letter 2007.(Accessed January 2016)
  16. S. Food and Drugs Administration (FDA). DEPARTMENT OF HEALTH & HUMAN SERVICES – Daiichi Sankyo Warning Letter 2013.(Accessed January 2016)
  17. Ranbaxy pleads guilty, to pay $500 mln in settlement.http://in.reuters.com/article/ranbaxy-settlement-felony-usa-idINDEE94C0DA20130513 (Accessed January 2016)
  18. Forest Laboratories. (2014, March 31). Form 10-K. United States Securities and Exchange Commission. (Accessed January 2016)
  19. Forest Laboratories. (2014, February 6). Form 10-Q. United States Securities and Exchange Commission. (Accessed January 2016)
  20. Van Zwieten PA. Angiotensin II receptor antagonists (AT1-blockers, ARBs, sartans): similarities and differences. Netherlands Heart Journal. 2006;14(11):381-387.
  21. James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427.
  22. Benicar HCT® Full Prescribing Information. (Accessed January 2016)
  23. Azor HCT® Full Prescribing Information. (Accessed January 2016)
  24. Tribenzor HCT® Full Prescribing Information. (Accessed January 2016).
  25. Di Sabatino A, Corazza GR (April 2009). “Coeliac disease“. Lancet 373 (9673): 1480–93. doi:10.1016/S0140-6736(09)60254-3. PMID 19394538.
  26. Tran TH, Li H. Olmesartan and Drug-Induced Enteropathy. Pharmacy and Therapeutics. 2014;39(1):47-50.
  27. Marietta, E. V., Nadeau, A. M., Cartee, A. K., Singh, I., Rishi, A., Choung, R. S., Wu, T.-T., Rubio-Tapia, A. and Murray, J. A. (2015), Immunopathogenesis of olmesartan-associated enteropathy. Alimentary Pharmacology & Therapeutics, 42: 1303–1314. doi: 10.1111/apt.13413
  28. Centers for Disease Control and Prevention (CDC). High Blood Pressure. (Accessed February 2016).
  29. Perunicic-Pekovic G, Pljesa S, Rasic-Milutinovic Z, Stankovic S, Ilic M, Maletic R. Inflammatory cytokines and malnutrition as related to risk for cardiovascular disease in hemodialysis patients. Can J Physiol Pharmacol. 2008 Apr;86(4):205-9. doi: 10.1139/Y08-018.
  30. Roberto Pecoits-Filho, Bengt Lindholm, Peter Stenvinkel. The malnutrition, inflammation, and atherosclerosis (MIA) syndrome – the heart of the matter. Nephrol Dial Transplant (2002) 17 [Suppl 11]: 28– 31
  31. Tuttolomondo A, Di Raimondo D, Pecoraro R, Arnao V, Pinto A, Licata G.Atherosclerosis as an inflammatory disease. Curr Pharm Des. 2012;18(28):4266-88.
  32. American College of Cardiology, news release, March 29, 2014
  33. L. Emilsson; R. Carlsson; M. Holmqvist; S. James; J. F. Ludvigsson. The Characterisation and Risk Factors of Ischaemic Heart Disease in Patients With Coeliac Disease. Aliment Pharmacol Ther. 2013;37(9):905-914.

Breast Implants

  1. Rexina Mize et al v. Mentor Worldwide LLC et al. Case Number CV 17-1747 DMG (KSx).
  2. Loftus v. Allergan, Inc., et al. U.S. District Court for the Southern District of West Virginia case number: 2:17-cv-01430
  3. Jef Feeley and Edvard Pettersson (February 3, 2017). Johnson & Johnson Unit Sued Over Leaking Breast Implants. Bloomberg.
  4. Stephanie Saul (November 18, 2006). F.D.A. Will Allow Breast Implants Made of Silicone. The New York Times.
  5. U.S. Food and Drug Administration. Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006). www.fda.gov
  6. U.S. Food and Drug Administration. Breast Implants: Update – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). www.fda.gov
  7. U.S. Food and Drug Administration.Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. www.fda.gov
  8. Hölmich LR, et al. Untreated silicone breast implant rupture. Plast Reconstr Surg. 2004 Jul;114(1):204-14; discussion 215-6.

Bravelle

  1. U.S. Food and Drug Administration (FDA). Bravelle Full Prescribing Information. Retrieved from http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21484_Bravelle_lbl.pdf
  2. Van Wely, M, et al. Urofollitropin and ovulation induction. Treatments in endocrinology. 4 (3): 155–165
  3. E. Lenton, et al. Induction of ovulation in women undergoing assisted reproductive techniques: recombinant human FSH (follitropin alpha) versus highly purified urinary FSH (urofollitropin HP)., in Hum Reprod, vol. 15, nº 5, Mag 2000, pp. 1021-7
  4. M. van Wely, C, et al. Urofollitropin and ovulation induction., in Treat Endocrinol, vol. 4, nº 3, 2005, pp. 155-65, PMID 15898821
  5. Ferring Pharmaceuticals. Bravelle Patient Reimbursement Program Information. Retrieved from: http://bravellereimbursement.com/
  6. Centers for Disease Control and Prevention (CDC). Infertility – Reproductive Health. www.cdc.gov (Accessed August 2016)
  7. C. Butticè, February 23, 2016. Coping with infertility – The hardships of conceiving a baby. MedsNews (Accessed September 2016)
  8. CTV News, B.C. couple launches class-action lawsuit over ineffective fertility drug. February 16, 2016. CTVNews.ca (Accessed September 2016)

Concerta

  1. Ritalin® hydrochloride methylphenidate hydrochloride USP tablets. Full prescribing information. (Accessed June 2016)
  2. CONCERTA® (methylphenidate HCl) Extended-release Tablets CII. Full prescribing information. (Accessed August 2016)
  3. Hedi Schelleman, Warren B. Bilker, et al. ”Methylphenidate and Risk of Serious Cardiovascular Events in Adults,” American Journal of Psychiatry, Vol. 169, No. 2, February 1, 2012.
  4. Kimko, HC; Cross, JT; Abernethy, DR (December 1999). “Pharmacokinetics and clinical effectiveness of methylphenidate.”. Clinical pharmacokinetics 37 (6): 457–70.
  5. U.S. Food and Drugs Administration (FDA). News & Events. FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events. www.fda.gov (Accessed August 2016)
  6. U.S. Food and Drugs Administration (FDA). FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes. www.fda.gov (Accessed August 2016)
  7. Volkow ND, Ding YS, Fowler JS, Wang GJ, Logan J, Gatley JS, Dewey S, Ashby C, Liebermann J, Hitzemann R, et al. Is methylphenidate like cocaine? Studies on their pharmacokinetics and distribution in the human brain. Arch Gen Psychiatry. 1995 Jun;52(6):456-63.
  8. McCarthy S, Cranswick N, Potts L, Taylor E, Wong IC. Mortality associated with attention-deficit hyperactivity disorder (ADHD) drug treatment: a retrospective cohort study of children, adolescents and young adults using the general practice research database. Drug Saf. 2009;32(11):1089-96. doi: 10.2165/11317630-000000000-00000.
  9. Safer DJ, Zito JM, Fine EM. Pediatrics. Increased methylphenidate usage for attention deficit disorder in the 1990s. 1996 Dec;98(6 Pt 1):1084-8
  10. C. Butticè. Vyvanse and Adderall: a monstrosity sold to our children. September 24, 2016. Meds News. (Accessed August 2016)
  11. Epstein-Ngo QM, McCabe SE2 Veliz PT, Stoddard SA, Austic EA, Boyd CJ. “Diversion of ADHD Stimulants and Victimization Among Adolescents.” J Pediatr Psychol. 2015 Nov 19. pii: jsv105
  12. David Bruser, Jesse McLean. March 30, 2015. Health Canada issues “stronger, clearer” warnings about suicide risks linked to ADHD drugs. thestar.com
  13. Manor I, Gutnik I, Ben-Dor DH, Apter A, Sever J, Tyano S, Weizman A, Zalsman G.Possible association between attention deficit hyperactivity disorder and attempted suicide in adolescents – a pilot study. Eur Psychiatry. 2010 Apr;25(3):146-50. doi: 10.1016/j.eurpsy.2009.06.001. Epub 2009 Aug 20.
  14. The United States Department of Justice. September 24, 2014. Shire Pharmaceuticals LLC to Pay $56.5 Million to Resolve False Claims Act Allegations Relating to Drug Marketing and Promotion Practices. www.justice.gov (Accessed July 2016)
  15. National Institute on Drug Abuse; National Institutes of Health; U.S. Department of Health and Human Services. DrugFacts: Stimulant ADHD Medications: Methylphenidate and Amphetamines. January 2014. www.drugabuse.gov (Accessed July 2016).
  16. Trenque T, Herlem E, Abou Taam M, Drame M. Methylphenidate off-label use and safety. Springerplus. 2014 Jun 7;3:286. doi: 10.1186/2193-1801-3-286. eCollection 2014.
  17. Centers for Disease Control and Prevention (CDC). Attention-Deficit / Hyperactivity Disorder (ADHD) – Data and Statistics. cdc.gov (Accessed May 2016)

E-cigarettes

  1. U.S. Fire Administration. (October 2014). Electronic cigarette fires and explosions. Retrieved from https://www.usfa.fema.gov/downloads/pdf/publications/electronic_cigarettes.pdf
  2. Joseph G. Allen, et al. Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and Acetoin in a Sample of 51 Products, Including Fruit-, Candy-, and Cocktail-Flavored E-Cigarettes. Environ Health Perspect; DOI:10.1289/ehp.1510185
  3. Sara Randazzo. July 3, 2016 E-Cigarette Users Sue Over Exploding Devices. The Wall Street Journal
  4. Tony Kovaleski, et al. Feb 8, 2017. Colorado sees alarming spike in e-cigarette explosions. Denver 7
  5. Centers for Disease Control and Prevention. (December 19, 2016). CDC – Flavorings-related lung disease – NIOSH workplace safety and health topic. Retrieved from http://www.cdc.gov/niosh/topics/flavorings/
  6. U.S. Food and Drug Administration (FDA). Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS). Accessed February 2017
  7. Hailey Branson-Potts, October 1, 2015. Woman burned by exploding e-cigarette battery awarded $1.9 million. The Los Angeles Times

Eliquis

  1. Burton, Thomas M.; Rockoff, Jonathan D. July 9, 2013. Mix-Ups in Clinical Trial Delayed Drug’s Approval. Wall Street Journal.
  2. Armstrong, D. July 9, 2013. Chinese Trial Misconduct Delayed Bristol-Myers Medicine. Bloomberg
  3. John Fauber, August 02, 2015. Slippery Slope: FDA Reviewer Questions Eliquis Mortality Claim. Milwaukee Journal Sentinel, MedPage Today; Coulter Jones.
  4. “Bleeding with dabigatran, rivaroxaban, apixaban. No antidote, and little clinical experience.” Prescrire Int. 2013 Jun;22(139):155-9.
  5. United States District Court – Eastern District of Louisiana. MDL – 2592 Xarelto Products Liability Litigation. (Accessed December 2016)
  6. United States District Court – Southern District of New York. Case Number 1:15-cv-04620-JSR. (Accessed November 2016)
  7. United States District Court – Southern District of New York. Case MDL No. 2754. In RE: Eliquis (Apixaban) products liability litigation.
  8. Katie Thomas, May 28, 2014. $650 Million to Settle Blood Thinner Lawsuits. New York Times
  9. Portola Pharmaceuticals News Release. Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa™ (andexanet alfa). Retrieved from: http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=2196085
  10. 10. Aisenberg J. Gastrointestinal Endoscopy in Patients Taking Novel Oral Anticoagulants. Gastroenterology & Hepatology. 2014;10(2):117-119.
  11. Christopher B. Granger, et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2011; 365:981-992September 15, 2011DOI: 10.1056/NEJMoa1107039
  12. U.S. Food and Drug Administration (FDA). Eliquis (apixaban) Tablets. www.fda.gov (Accessed December 2016)

Essure

  1. “Essure™ System – P020014”. US Food and Drug Administration. 2009-06-29. Retrieved 2011-05-21
  2. Regan Morris (June 24, 2014). “Erin Brockovich calls for end to Bayer’s Essure”. BBC News, Los Angeles. (Accessed November 2015)
  3. Walsh V. Bayer. (2013) In the Court of Common Pleas, Philadelphia County. Civil Action Complaint 20-Other Personal Injury. Retrieved from http://www.cbgnetwork.org/downloads/Essure_Charge_Philadelphia.pdf
  4. “Women report complications from Essure birth control”.Chicago Tribune. Retrieved March 2, 2014
  5. FDA. (2015). Essure Permanent Birth Control: Review of reported problems. Retrieved on March 2015
  6. De la Paz v. Bayer et al. (2015). In the United States District Court Northern District of California. Complaint for Damages and Demand for Jury Trial. Case3:15-cv-03995-LB.
  7. FDA. (2015). Essure Permanent Birth Control. Update on the status of FDA’s evaluation of the Essure System. Accessed June 2016
  8. FDA. (2015). Summary of Safety and Effectiveness Data. Accessed June 2016
  9. Mao Jialin, Pfeifer Samantha, Schlegel Peter, Sedrakyan Art. Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study. BMJ 2015; 351 :h5162
  10. Kerin JF, Cooper JM, Price T, Herendael BJ, Cayuela-Font E, Cher D, Carignan CS. Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study. Hum Reprod. 2003 Jun;18(6):1223-30.
  11. Conceptus, Phase II Clinical Study Final Report. Retrieved on January 2016
  12. C. Butticè. “FDA issues Black Box warning for Essure — Lawsuits keep growing“. Digital Journal, March 30, 2016
  13. C. Butticè. “Essure – Safe Birth Control or Dangerous Medical Device?” MedsNews, January 8, 2016
  14. Rob Stein. FDA Revisits Safety Of Essure Contraceptive Device. September 21, 2015. NPR News
  15. Lauren Gilger , Maria Tomasch. Essure birth control: Thousands of women reporting severe medical reactions to Essure. October 24, 2014. ABC 15 Arizona
  16. Tara Haelle. FDA To Take Another Look At Essure Contraceptive Device After Health Complaints. July 14, 2015. NPR News

Hernia Mesh

  1. Vogels, R.K. Barneveld, J. Bosmans, G. Beets, M. Gijbels, M. Schreinemacher, and N. Bouvy, 2015. “Long-term evaluation of adhesion formation adn foreign body response to three new meshes.” Surgical Endoscopy 29, no. 8:2251.
  2. Deeken, Corey R. Ketih M Faucher, and Brent D Matthews. 2012. “A review of the composition, characteristics, and effectiveness of barrier mesh prostheses utilized for laparoscopic ventral hernia repair.” Surgical Endoscopy 26, no. 2: 566-575
  3. Deerenberg, EB, IM Mulder, N Grotenhuis, M Ditzel, J Jeekel, and JF Lange, N.d. “Experimental study on synthetic and biological mesh implantation in a contaminated environment.” British Journal of Surgery 99, no. 12: 1734-1741
  4. Schreinemacher, M. H. F. P. J. Emans, M. J. J. Gijbels, J.-W.M. Greve, Gl.L. Beets, and N.D. Bouvy, 2009. “Degradation of mesh coatings and intraperitoneal adhesion formation in an experimental model.” British Journal of Surgery 96, no. 3:305-313
  5. Product Information. Hifax EPR 60/M Bianco Polypropylene powder used for field-joint applications at ultra high temperatures. Lyondel Basell. Retrieved from: https://www.lyondellbasell.com/globalassets/documents/polymers-technical-literature/hifax-epr-60-m-bianco-polypropylene-powder-used-for-field-joint-applications-at-ultra-high-temperatures.pdf
  6. Bibeka Shrestha. Bard Offers $184M To Settle Hernia Patch Suits. Law360 (Accessed December 2016).
  7. S. Food and Drug Administration (FDA). Hernia Surgical Mesh Implants. www.fda.gov (Accessed December 2016)
  8. In Re: Kugel Mesh Hernia Patch Litigation, MDL Docket No. 1842, No. 07-1842.
  9. Christopher Thorpe v. C.R. Bard, Inc., et al., No. 08-463
  10. Bard – Davol Inc. January 10, 2007. Product Recall Information. Hernia Repair. Retrieved from: http://www.davol.com/clinical-support/product-recall-information/

Hyland’s Teething Tablets

  1. U.S. Food and Drug Administration (FDA). FDA warns against the use of homeopathic teething tablets and gels. September 30, 2016. www.fda.gov. (Accessed November 2016)
  2. U.S. Food and Drug Administration (FDA). FDA Issues Consumer Safety Alert. Hyland’s Teething Tablets may pose a risk to children. October 23, 2010. www.fda.gov. (Accessed November 2016)
  3. Jen Christensen, Jamie Gumbrecht, October 13, 2016. Teething tablets may be linked to 10 children’s deaths, FDA says. CNN (Accessed October 2016)
  4. Wendy Sue Swanson, MD. How to Help Teething Symptoms without Medications. American Academy of Pediatrics, Healthychildren.org
  5. Potter, Samuel O.L. (1893). A Handbook of Materia Medica Pharmacy and Therapeutics. London: P. Blakiston’s.
  6. National Institutes of Health (NIH). National Center for Complementary and Integrative Health. Homeopathy. Retrieved from: https://nccih.nih.gov/health/homeopathy
  7. Hyland’s Homeopathic. Frequently Asked Questions. Retrieved from: https://www.hylands.com/faq-about-discontinuation-teething-tablets-and-gel
  8. United States District Court – Central District of California. Kim Allen, et al. v. Hyland’s Inc., et al., Case No. 2:12-cv-01150

Invokana

  1. INVOKANA® product information. www.janssen.com (Accessed September 2016)
  2. IMS Health: Total Patient Tracker (TPT). July 2014 through June 2015. Extracted August 2015. File: DATA 2015- Canagliflozin DSC.
  3. Institute for Safe Medication Practices (ISMP). Quarterwatch May 6, 2015 — Data from 2014 Quarter 2. (Accessed September 2016)
  4. C. Butticè. Invokana causing kidney failure in patients. September 15, 2015. Meds News. (Accessed September 2016)
  5. Taylor SI, et al. SGLT2 Inhibitors May Predispose to Ketoacidosis. J Clin Endocrinol Metab. 2015 Aug;100(8):2849-52. doi: 10.1210/jc.2015-1884. Epub 2015 Jun 18.
  6. Briand F, et al. Empagliflozin, via Switching Metabolism towards Lipid Utilization, Moderately Increases LDL-cholesterol Levels through Reduced LDL Catabolism. Diabetes 2016 Apr; db160049. http://dx.doi.org/10.2337/db16-0049
  7. Ptaszynska A, et al. Assessing bladder cancer risk in type 2 diabetes clinical trials: the dapagliflozin drug development program as a ‘case study’. Diabetes Ther. 2015 Sep; 6(3): 357-375
  8. Lavalle-González, F. J., et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia, 56(12), 2582–2592. http://doi.org/10.1007/s00125-013-3039-1
  9. Haas, B, et al. “Efficacy, safety and regulatory status of SGLT2 inhibitors: focus on canagliflozin.” Nutrition & Diabetes 4 (11): e143. doi:10.1038/nutd.2014.40. ISSN 2044-4052
  10. U.S. Food And Drug Administration (FDA). FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). www.fda.gov. (Accessed October 2016)
  11. U.S. Food And Drug Administration (FDA). FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. www.fda.gov. (Accessed August 2016)
  12. U.S. Food And Drug Administration (FDA). FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate. www.fda.gov. (Accessed September 2016)
  13. U.S. Food And Drug Administration (FDA). FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density. 09-10-2015, www.fda.gov. (Accessed July 2016)
  14. Eva C. and John T. Galambos vs. Ethicon, Inc. et al. United States District Court for the Northern District of Geogia, Atlanta Division (April 7, 2015)
  15. Paula Brazil vs. Janssen Research & Development LLC. et al. United States District Court for the Northern District of Georgia. (October 29, 2015)
  16. Luana Jean Collie vs. Janssen Research & Development, LLC; Janssen Pharmaceuticals, INC, Johnson & Johnson Co.; and Mitsubishi Tanabe Pharma Corp. Case 1:15-cv-00636-CB-C Document 1 Filed 12/15/15. United States District Court Southern District of Alabama Southern Division. (Accessed October 2016)

IVC Filters

  1. Sarosiek S, Crowther M, Sloan JM. “Indications, complications, and management of inferior vena cava filters: the experience in 952 patients at an academic hospital with a level I trauma center.” JAMA Intern Med. 2013 Apr 8;173(7):513-7. doi: 10.1001/jamainternmed.2013.343.
  2. Tim Sandler, Stacey Naggiar, Stephanie Gosk. Did Forged Signature Clear Way for Dangerous Blood-Clot Filter? September 4, 2015. NBC News. (Accessed August 2016)
  3. Durack JC, Westphalen AC, Kekulawela S, Bhanu SB, Avrin DE, Gordon RL, Kerlan RK. Perforation of the IVC: rule rather than exception after longer indwelling times for the Günther Tulip and Celect retrievable filters. Cardiovasc Intervent Radiol. 2012 Apr;35(2):299-308. doi: 10.1007/s00270-011-0151-9. Epub 2011 Mar 30.
  4. C. Butticè. IVC Filters – a life-threatening medical device. Meds News. October 28, 2015. (Accessed June 2016)
  5. Food and Drug Administration (FDA). “Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication”. May 6, 2014. www.fda.gov. (Accessed May 2016)
  6. Food and Drug Administration (FDA). Inspections, Compliance, Enforcement, and Criminal Investigations. C.R. Bard, Inc. 7/13/15 – Warning Letter. www.fda.gov. (Accessed August 2016)
  7. Food and Drug Administration (FDA). “Inferior Vena Cava (IVC) Filters: initial Communication: Risk of Adverse Events with Long Term Usage”. August 09, 2010. www.fda.gov. (Accessed July 2016)
  8. The PREPIC Study Group. “Eight-Year Follow-Up of Patients With Permanent Vena Cava Filters in the Prevention of Pulmonary Embolism.” Circulation , ,
  9. United States District Court. Southern District of Indiana. MDL Case Information. MDL No. 2570 IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation. http://www.insd.uscourts.gov/ (Accessed July 2016)
  10. United States District Court. District of Arizona.I N RE: Bard IVC Filters Products Liability Litigation. http://www.azd.uscourts.gov/ (Accessed August 2016)
  11. Nicholson W, et al. “Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade.”Arch Intern Med. 2010 Nov 8;170(20):1827-31. doi: 10.1001/archinternmed.2010.316.
  12. Tam MD, et al. “Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening complications.” J Vasc Interv Radiol. 2012 Feb;23(2):199-205.e1. doi: 10.1016/j.jvir.2011.10.017.

Levaquin

  1. The U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication – FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. (Retrieved from: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM500591.pdf)
  2. Andersson MI, MacGowan AP (2003). “Development of the quinolones”. Journal of Antimicrobial Chemotherapy. 51 (Suppl. S1): 1–11.
  3. Hooper, DC. (Mar–Apr 2001). “Emerging mechanisms of fluoroquinolone resistance”. Emerging Infectious Diseases. 7 (2): 337–41
  4. U.S. District Court District of Minnesota.(n.d.). Fluoroquinolone MDL | 15-MD-2642
  5. Daneman N, Lu H, Redelmeier DA Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study BMJ Open 2015;5:e010077. doi: 10.1136/bmjopen-2015-010077
  6. Grossman v. Johnson & Johnson et al. (2014, August 6). Complaint for damages and demand for jury trial. United States District Court Northern District Of California San Francisco Division. Case No. 3:14-cv-03557.
  7. Trang Do (2016). Johnson & Johnson, former FDA commissioner among defendants in Levaquin lawsuit. ABC 2 News.
  8. Chien-Chang Lee, et al. Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone. JAMA Intern Med. 2015;175(11):1839-1847. doi:10.1001/jamainternmed.2015.5389
  9. S. T. Bird, M. Etminan, J. M. Brophy, A. G. Hartzema, J. A. C. Delaney. Risk of acute kidney injury associated with the use of fluoroquinolones. Canadian Medical Association Journal, 2013
  10. Mahyar Etminan, et al. Oral fluoroquinolone use and risk of peripheral neuropathy. A pharmacoepidemiologic study. Neurology September 30, 2014 vol. 83 no. 14 1261-1263
  11. Grill MF, Maganti RK. Neurotoxic effects associated with antibiotic use: management considerations. British Journal of Clinical Pharmacology. 2011;72(3):381-393. doi:10.1111/j.1365-2125.2011.03991.x.

Mirena

  1. Jennifer Couzin-Frankel, (July 15, 2011). Contraceptive Comeback: The Maligned IUD Gets a Second Chance. Wired
  2. Etminan M, Luo H, Gustafson P. Risk of intracranial hypertension with intrauterine levonorgestrel. Therapeutic Advances in Drug Safety. 2015;6(3):110-113. doi:10.1177/2042098615588084.
  3. Alder JB, Fraunfelder FT, Edwards R. Levonorgestrel implants and intracranial hypertension. N Engl J Med. 1995 Jun 22;332(25):1720-1
  4. Food and Drug Administration. (2008 July). Mirena (levonorgestrel-releasing intrauterine system). Accessed from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf
  5. Costescu DJ. Levonorgestrel-releasing intrauterine systems for long-acting contraception: current perspectives, safety, and patient counseling. International Journal of Women’s Health. 2016;8:589-598. doi:10.2147/IJWH.S99705.
  6. In Re: Mirena IUD Products Liability Litigation. (2016, July 28). Opinion & Order, United States District Court Southern District of New York, MDL No. 2434. Case 7:13-mc-02434-CS-LMS.
  7. Everett-Carey v. Bayer et al. (2017, February 2017). Complaint and Demand for Jury Trial, United States District Court District of New Jersey Newark Division. Case 2:17-cv-00891.

Morcellators

  1. U.S. Food and Drug Administration (FDA). Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators. www.fda.gov. November 25, 2014.
  2. U.S. Food and Drug Administration (FDA). FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients. April 7, 2016.
  3. U.S. Food and Drug Administration (FDA). FDA warns against using laparoscopic power morcellators to treat uterine fibroids. www.fda.gov. November 24, 2014.
  4. United States judicial Panel on Multidistrict litigation. In re: Power Morcellator products liability litigation MDL No. 2652
  5. Parker, WH. Uterine myomas: management. Fertil Steril. 2007 Aug;88(2):255-71. Epub 2007 Jul 20
  6. GM Savage, et al. Disposable laparoscopic morcellator – US Patent 6,039,748, 2000
  7. Cohen S, Greenberg JA. Hysteroscopic Morcellation for Treating Intrauterine Pathology. Reviews in Obstetrics and Gynecology. 2011;4(2):73-80.
  8. Jennifer Levitz. May 27, 2015. Johnson & Johnson Settling Cases Tied to Device That Can Spread Uterine Cancer. The Wall Street Journal. (Accessed October 2016).
  9. Jennifer Levitz. March 18, 2016. FBI Is Investigating Hysterectomy Device Found to Spread Uterine Cancer. The Wall Street Journal. (Accessed September 2016).

Nexium and Prilosec

  1. Nexium – full product information. Wilmington, DE, USA: AstraZeneca, 2016
  2. Moore RA, Derry S, Simon LS, Emery P. Nonsteroidal anti-inflammatory drugs, gastroprotection, and benefit-risk. Pain Pract. 2014 Apr;14(4):378-95. doi: 10.1111/papr.12100.
  3. Zajac, P; Holbrook, A; Super, ME; Vogt, M (March–April 2013). “An overview: Current clinical guidelines for the evaluation, diagnosis, treatment, and management of dyspepsia“. Osteopathic Family Physician 5 (2): 79–85. doi:10.1016/j.osfp.2012.10.005.
  4. Sachs, G.; Shin, J. M.; Howden, C. W. (2006). “Review article: The clinical pharmacology of proton pump inhibitors“. Alimentary Pharmacology and Therapeutics 23: 2–8. doi:10.1111/j.1365-2036.2006.02943.x. PMID 16700898.
  5. Charlene Laino. Are acid reflux drugs overused? CBS News. December 27, 2011
  6. The Family Health Guide. Do PPIs have long-term side effects? Harvard Health Publications – Harvard Medical School. February 1, 2009.
  7. Corleto VD, Festa S, Di Giulio E, Annibale B. Proton pump inhibitor therapy and potential long-term harm. Curr Opin Endocrinol Diabetes Obes. 2014 Feb;21(1):3-8.
  8. James W. Freston, Kurt Borch, Stephen J. Brand, et al. Effects of hypochlorhydria and hypergastrinemia on structure and function of gastrointestinal cells. Digestive Diseases and Sciences, 1995, Volume 40, Number 2, Page 50S
  9. Jansen JB, Klinkenberg-Knol EC, Meuwissen SG, De Bruijne JW, Festen HP, Snel P, Lückers AE, Biemond I, Lamers CB. Effect of long-term treatment with omeprazole on serum gastrin and serum group A and C pepsinogens in patients with reflux esophagitis. 1990 Sep;99(3):621-8.
  10. Tsukamoto H, Mizoshita T, Sasaki M, et al. Long-term high-dose proton pump inhibitor administration to Helicobacter pylori-infected Mongolian gerbils enhances neuroendocrine tumor development in the glandular stomach. Asian Pac J Cancer Prev. 2011;12(4):1049-54.
  11. Wang JS, Varro A, Lightdale CJ, Lerkowit N, et al. Elevated serum gastrin is associated with a history of advanced neoplasia in Barrett’s esophagus. Am J Gastroenterol 2010; 105:1039–1045.
  12. McColl KEL. Effect of proton pump inhibitors on vitamins and iron. Am J Gastroenterol 2009; 104:S3–S9.
  13. Ito T, Jensen RT. Association of Long-term Proton Pump Inhibitor Therapy with Bone Fractures and effects on Absorption of Calcium, Vitamin B12, Iron, and Magnesium. Current gastroenterology reports. 2010;12(6):448-457. doi:10.1007/s11894-010-0141-0.
  14. Targownik LE, Lix LM, Leung S, Leslie WD. Proton pump inhibitor use is not associated with osteoporosis or accelerated bone mineral density loss. Gastroenterology 2010; 138:896–904
  15. S. Food And Drug Administration (FDA). FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors. March 23, 2011. http://www.fda.gov/ (Accessed May 2016)
  16. Merriman NA, Putt ME, Metz DC, Yang YX. Hip fracture risk in patients with a diagnosis of Pernicious Anemia. Gastroenterology 2010; 138:1330–1337.
  17. Toh JW, Ong E, Wilson R. Hypomagnesaemia associated with long-term use of proton pump inhibitors. Gastroenterology Report. 2015/08/01 00:00; 3(3)243-253
  18. Butticè. Nutrition for Dummies – How does the body process the food you eat. Meds News. November 27, 2015. (Accessed May 2016)
  19. Larner AJ, Hamilton MIR. Review article: infective complications of therapeutic gastric acid inhibition. Aliment Pharmacol Ther 1994; 8:579–584.
  20. Lombardo L, Foti M, Ruggia O, Chiecchio A. Increased incidence of small intestinal bacterial overgrowth during proton pump inhibitor therapy. Clin Gastroenterol Hepatol. 2010 Jun;8(6):504-8. doi: 10.1016/j.cgh.2009.12.022. Epub 2010 Jan 6.
  21. M Sandra Dial. Proton Pump Inhibitor Use and Enteric Infections. Am J Gastroenterol 2009; 104:S10–S16; doi:10.1038/ajg.2009.46
  22. Leonard J, Marshall JK, Moayyedi P. Systematic review of the risk of enteric infection in patients taking acid suppression. Am J Gastroenterol 2007; 102:2047–2056.
  23. Laheij RF, Sturkenboom MM, Hassing R, Dieleman J, Stricker BC, Jansen JJ. Risk of Community-Acquired Pneumonia and Use of Gastric Acid–Suppressive Drugs. JAMA. 2004;292(16):1955-1960. doi:10.1001/jama.292.16.1955.
  24. Benjamin Lazarus, et al. Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. JAMA Intern Med. 2016;176(2):. doi:10.1001/jamainternmed.2015.7193.
  25. Mayo Clinic. Diseases and Conditions – Chronic kidney disease org, Jan. 30, 2015. (Accessed May 2016)
  26. Nimeshan Geevasinga, Lukas Kairaitis, Gopala K Rangan, Patrick L Coleman. Acute interstitial nephritis secondary to esomeprazole. Med J Aust 2005; 182 (5): 235-236.
  27. S. Food And Drug Administration (FDA). Nexium (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg; Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg. December 2014. http://www.fda.gov/ (Accessed May 2016)
  28. Nigam H. Shah, Paea LePendu e Anna Bauer-Mehren. Proton Pump Inhibitor Usage and the Risk of Myocardial Infarction in the General Population in PLOS ONE, vol. 10, nº 6, 10 giugno 2015, pp. e0124653, DOI:10.1371/journal.pone.0124653.
  29. Ghebremariam YT, LePendu P, Lee JC, Erlanson DA, Slaviero A, Shah NH, et al. Unexpected effect of proton pump inhibitors: elevation of the cardiovascular risk factor asymmetric dimethylarginine. Circulation, 2013. 128(8): p. 845–53. doi: 10.1161/CIRCULATIONAHA.113.003602. pmid:23825361
  30. Tony Antoniou, et al. Proton pump inhibitors and the risk of acute kidney injury in older patients: a population-based cohort study. cmajo April 16, 2015 vol. 3 no. 2 E166-E171 doi: 10.9778/cmajo.20140074
  31. Gomm W, von Holt K, Thomé F, et al. Association of Proton Pump Inhibitors With Risk of Dementia: A Pharmacoepidemiological Claims Data Analysis. JAMA Neurol. 2016;73(4):410-416. doi:10.1001/jamaneurol.2015.4791.
  32. Naunton M, Peterson GM, Bleasel MD. Overuse of proton pump inhibitors. J Clin Pharm Ther 2000;25:333-40.
  33. Ogawa R, Echizen H: Drug–drug interaction profiles of proton pump inhibitors. Clin. Pharmacokinet. 49(8), 509–533 (2010).
  34. The National Institute for Health Care Management Research and Educational Foundation (NIHCM) “Prescription expenditures in 2000: the upward trend continues.” May 2001. (Accessed May 2016)
  35. “Omeprazole”. The American Society of Health-System Pharmacists. (Accessed May 2016)
  36. “Esomeprazole”. The American Society of Health-System Pharmacists. (Accessed May 2016)
  37. “Nexium”. The American Society of Health-System Pharmacists. (Accessed May 2016)
  38. Furuta T, Shirai N, Sugimoto M, Nakamura A, Hishida A, Ishizaki T (Jun 2005). “Influence of CYP2C19 pharmacogenetic polymorphism on proton pump inhibitor-based therapies“. Drug Metab Pharmacokinet 20 (3): 153–67. doi:10.2133/dmpk.20.153. PMID 15988117.
  39. Lind et al., Esomeprazole provides improved acid control vs. omeprazole in patients with symptoms of gastro-oesophageal reflux disease. Alimentary Pharmacology and Therapeutics 14.7: 861-67, 2000.
  40. Kahrilas, P. J. et al., Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomized controlled trial. Alimentary Pharmacology and Therapeutics 14.10: 1249-58, 2000.
  41. Grill, Markus and Hansen, Hans (2007): “Vorsicht, Pharma! Wie die Industrie Ärzte manipuliert und Patienten täuscht.” (‘Caution, Pharma! How the industry manipulates physicians and deceives patients.’) Published in the 16 August 2007 issue of Stern (Germany; pp. 100–107).
  42. Harris, G (2003-08-20). “Heartburn Drug Battle Likely“. The New York Times. (Accessed May 2016)

Onglyza

  1. Onglyza Full Prescribing Information. (Accessed June 2016)
  2. Kombiglyze XR full prescribing information. (Accessed June 2016)
  3. Augeri D; et al. (2005). “Discovery and preclinical profile of Saxagliptin (BMS-477118): a highly potent, long-acting, orally active dipeptidyl peptidase IV inhibitor for the treatment of type 2 ” Journal of Medicinal Chemistry 48 (15): 5025–5037. doi:10.1021/jm050261p. PMID 16033281.
  4. S. Food and Drug Administration. Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication – Risk of Heart Failure. April 5, 2016. www.fda.gov (Accessed June 2016)
  5. Benjamin M. Scirica, et al. “Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus.” N Engl J Med 2013; 369:1317-1326. October 3, 2013. DOI: 10.1056/NEJMoa1307684
  6. Monami M, Dicembrini I, Mannucci E. “Dipeptidyl peptidase-4 inhibitors and heart failure: a meta-analysis of randomized clinical trials.” Nutr Metab Cardiovasc Dis. 2014 Jul;24(7):689-97. doi: 10.1016/j.numecd.2014.01.017. Epub 2014 Mar 5.
  7. Clifton P. “Do dipeptidyl peptidase IV (DPP-IV) inhibitors cause heart failure?” Clin Ther. 2014 Dec 1;36(12):2072-9. doi: 10.1016/j.clinthera.2014.10.009. Epub 2014 Nov 13.
  8. Butler AE, Campbell-Thompson M, Gurlo T, Dawson DW, Atkinson M, Butler PC. “Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors.” Diabetes. 2013;62(7):2595-2604. doi:10.2337/db12-1686.
  9. Matveyenko AV, Dry S, Cox HI, et al. Beneficial Endocrine but Adverse Exocrine Effects of Sitagliptin in the Human Islet Amyloid Polypeptide Transgenic Rat Model of Type 2 Diabetes: Interactions With Metformin. Diabetes. 2009;58(7):1604-1615. doi:10.2337/db09-0058.
  10. Cory Renauer. Diabetes Drug Shakeup: What You Need to Know About New FDA Warnings. April 19, 2016. The Motley Fool.
  11. Robert Hadley Nov. 4, 2015. “Daughter sues AstraZeneca, alleging diabetes drug caused mother’s heart failure”. Cook County Record. (Accessed June 2016).
  12. United States District Court, Southern District of California (November 12, 2013). IN RE: Incretin mimetics products liability litigation. MDL Case No. 13md2452 AJB (MDD). (Accessed June 2016)
  13. United States Judicial Panel on Multidistrict Litigation (August 26, 2013). IN RE: Incretin mimetics products liability litigation. Case MDL No. 2452 Document 71 Filed 08/26/13. (Accessed June 2016)

Plavix

  1. U.S. Food And Drug Administration. Medication Guide Plavix® (PLAV-iks) (clopidogrel bisulfate) tablets. Retrieved from: http://www.fda.gov/downloads/drugs/drugsafety/ucm243349.pdf
  2. Hamilton, Richart (2015). Tarascon Pocket Pharmacopoeia 2015 Deluxe Lab-Coat Edition. Jones & Bartlett Learning. p. 147. ISBN 9781284057560.
  3. United States of America, ex rel. Elisa Dickson v. Bristol-Myers Squibb Co., et al., No. 13-1039, D. N.J.
  4. Hawaii v. Bristol-Myers Squibb Co. 14-1-0708-03, First Circuit Court, Honolulu, Hawaii
  5. Karen Gullo, March 20, 2014. Bristol-Myers, Sanofi Sued by Hawaii Over Plavix Labeling. Bloomberg
  6. Bristol-Myers Squibb Company v. Superior Court (Anderson), 16 S.O.S. 4412
  7. Diener HC, et al. Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial. Lancet. 2004 Jul 24-30;364(9431):331-7.
  8. Deepak L. Bhatt, et al. Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Events. N Engl J Med 2006; 354:1706-1717April 20, 2006DOI: 10.1056/NEJMoa060989
  9. U.S. Food And Drug Administration. Interaction between Esomeprazole/Omeprazole and Clopidogrel Label Change. Retrieved from: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm327922.htm
  10. Deepak L. Bhatt, et al. Clopidogrel with or without Omeprazole in Coronary Artery Disease. N Engl J Med 2010; 363:1909-1917November 11, 2010DOI: 10.1056/NEJMoa1007964
  11. U.S. Food And Drug Administration. Department of Health & Human Services. RE: NDA #20-839 PLAVIX® (clopidogrel bisulfate) Tablets MACMIS ID # 6889. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM167844.pdf
  12. U.S. Food And Drug Administration. Department of Health & Human Services. RE: NDA #20-839 PLAVIX® (clopidogrel bisulfate) 75 mg Tablets MACMIS ID # 10107. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM166458.pdf
  13. U.S. Food And Drug Administration. Department of Health & Human Services. RE: NDA #20-839 PLAVIX® (clopidogrel bisulfate) Tablets MACMIS ID # 17325. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM166248.pdf
  14. Backovic D, et al. Clopidogrel High On-Treatment Platelet Reactivity in Patients with Carotid Artery Stenosis Undergoing Endarterectomy. A Pilot Study. Curr Vasc Pharmacol. 2016;14(6):563-569.
  15. Fintel DJ. Antiplatelet therapy in cerebrovascular disease: implications of Management of Artherothrombosis with Clopidogrel in High-risk Patients and the Clopidogrel for High Artherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance studies’ results for cardiologists. Clin Cardiol. 2007 Dec;30(12):604-14.
  16. The SPS3 Investigators. Effects of Clopidogrel Added to Aspirin in Patients with Recent Lacunar Stroke. N Engl J Med 2012; 367:817-825August 30, 2012DOI: 10.1056/NEJMoa1204133

Risperdal

  1. U.S. Food and Drugs Administration (FDA). Atypical Antipsychotic Drugs Information. www.fda.org (Accessed August 2016)
  2. U.S. Food and Drugs Administration (FDA). RISPERDAL® Full prescribing information. www.fda.org (Accessed August 2016)
  3. U.S. Food and Drugs Administration (FDA). Alert for Healthcare Professionals: Risperidone (marketed as Risperdal). www.fda.org (Accessed June 2016)
  4. Gilbody SM, Bagnall AM, Duggan L, Tuunainen A. Risperidone versus other atypical antipsychotic medication for schizophrenia. Cochrane Database Syst Rev. 2000;(3):CD002306.
  5. Maher AR, Theodore G. Summary of the comparative effectiveness review on off-label use of atypical antipsychotics. J Manag Care Pharm. 18 (5 Suppl B): S1–20. PMID 22784311.
  6. Cookson J, Hodgson R, Wildgust HJ. Prolactin, hyperprolactinaemia and antipsychotic treatment: a review and lessons for treatment of early psychosis. J Psychopharmacol. 2012 May;26(5 Suppl):42-51. doi: 10.1177/0269881112442016. Epub 2012 Apr 2.
  7. Holzer L, Eap CB. Risperidone-induced symptomatic hyperprolactinaemia in adolescents. J Clin Psychopharmacol. 2006 Apr;26(2):167-71.
  8. The United States Department of Justice. Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations. www.justice.gov. (Accessed August 2016)
  9. Jef Feeley, Margaret Cronin Fisk. J&J Pushed Risperdal with Golf, Popcorn, Witness Says. Bloomberg, September 27, 2012. www.bloomberg.com. (Accessed July 2016)
  10. Johnson & Johnson. Quarterly Sales & Earnings. www.investor.jnj.com (Accessed June 2016)
  11. Pringsheim T, Doja A, Belanger S, Patten S, The Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children (CAMESA) guideline group. Treatment recommendations for extrapyramidal side effects associated with second-generation antipsychotic use in children and youth. Paediatrics & Child Health. 2011;16(9):590-598.
  12. Haupt M, Cruz-Jentoft A, Jeste D. Mortality in elderly dementia patients treated with risperidone. J Clin Psychopharmacol. 2006 Dec;26(6):566-70.
  13. Ed Silverman, September 11, 2012. J&J Sees Male Breasts And Quickly Settles Risperdal Suit. Forbes. (Accessed May 2016)
  14. Pledger v. Janssen Pharmaceuticals Inc. et al., case number 120401997, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia
  15. Jef Feeley, July 1, 2016. J&J Hit With $70 Million Risperdal Verdict Over Male Breasts. Bloomberg (Accessed August 2016)
  16. Steven Brill. America’s most admired lawbreaker. The Huffington Post. (Accessed August 2016)

Roundup

  1. K. Kelland. U.N. experts find weed killer glyphosate unlikely to cause cancer. Reuters, May 16, 2016.
  2. The Alliance for Natural Health USA. Glyphosate Levels in Breakfast Foods: What is safe? April 19, 2016.(Accessed May 2016)
  3. C. Butticè. Is Monsanto’s Roundup Weed Killer Carcinogenic or Not? EPA takes its report offline. The Ring of Fire, May 6, 2016. (Accessed May 2016)
  4. McDuffie H. H., et al. Non-Hodgkin’s Lymphoma and Specific Pesticide Exposures in Men. Cross-Canada Study of Pesticides and Health. Cancer Epidemiol Biomarkers Prev November 2001 10; 1155
  5. Food and Agriculture Organization of the United Nations (FAO). Joint FAO/WHO meeting on pesticide residues. Geneva, 9–13 May 2016 – Summary Report. World Health Organization (WHO), May 16, 2016. (Accessed May 2016)
  6. Eriksson M, et al. Pesticide exposure as risk factor for non-Hodgkin lymphoma including histopathological subgroup analysis. Int J Cancer. 2008 Oct 1;123(7):1657-63. doi: 10.1002/ijc.23589.
  7. International Agency for Research on Cancer (IARC). IARC Monographs Volume 112: evaluation of
    five organophosphate insecticides and herbicides. March 20, 2015. (Accessed May 2016)Krüger M., et al.
  8. Krüger M., et al. Detection of Glyphosate Residues in Animals and Humans. J Environ Anal Toxicol 2014, 4:2 http://dx.doi.org/10.4172/2161-0525.1000210
  9. De Roos AJ, et al. Integrative assessment of multiple pesticides as risk factors for non-Hodgkin’s lymphoma among men. Occupational and Environmental Medicine. 2003;60(9):e11. doi:10.1136/oem.60.9.e11.
  10. WHO (2006) Pesticide residues in food – 2004 Joint FAO/WHO Meeting on Pesticide Residues. Part II—Toxicological. WHO/PCS/06.1, 2006
  11. Thiel A (2007a) Magnitude of residues of glyphosate and degradates in aspirated grain and processed fractions (starch, grits, flour, refined oil (wet milling) refined oil (dry milling) and meal (dry milling) of a field corn line containing event DP-Ø9814Ø-6 following applications of glyphosate containing herbicides – United States and Canadian locations, Season 2006. DuPont Study Number: DuPont-19836. PHI Study Number: PHI-2006-187. ABC Study Number: 50165-1. Unpublished report.

Talcum Powder

  1. Ness, R. Does talcum exposure cause ovarian cancer? IGCS-0015 Ovarian Cancer. International Journal of Gynecological Cancer: May 2015 – Volume 25 – Issue – p 51
  2. Cramer DW, et al. The Association Between Talc Use and Ovarian Cancer: A Retrospective Case–Control Study in Two US States. Epidemiology (Cambridge, Mass). 2016;27(3):334-346. doi:10.1097/EDE.0000000000000434.
  3. Gertig, D., et al. “Prospective Study of Talc Use and Ovarian Cancer”. JNCI Journal of the National Cancer Institute 92 (3): 249–252. doi:10.1093/jnci/92.3.249.
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  5. S. Food and Drugs Administration (FDA). Ingredients – Talc. www.fda.gov (Accessed July 2016).
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Taxotere

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Testosterone

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Transvaginal Mesh

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  8. Joe Carlson. Boston Scientific hit with $73.5 million jury verdict in mesh case. September 10, 2014, Star Tribune.
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Xarelto

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  71. O’Brien EC, Kim S, Hess PL, et al. Effect of the 2014 Atrial Fibrillation Guideline Revisions on the Proportion of Patients Recommended for Oral Anticoagulation.JAMA Intern Med. 2015;175(5):848-850. doi:10.1001/jamainternmed.2015.13.
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  74. Journal of Neurosurgery May 2012 / Vol. 116 / No. 5 / Pages 1093-1096. “Neurosurgical complications of direct thrombin inhibitors—catastrophic hemorrhage after mild traumatic brain injury in a patient receiving dabigatran. Case report” Sarah T. Garber, M.D., Walavan Sivakumar, M.D., and Richard H. Schmidt, M.D., Ph.D. Published online March 6, 2012; DOI: 10.3171/2012.2.JNS112132.
  75. Nannapaneni N, Singh R, Mckay P, Al-Hajeili M. Managing a Rivaroxaban Bleed: Understanding the Difficulties in Acute Reversal of the New Oral Anticoagulants through a Case Report. Case Reports in Hematology. 2014;2014:548272. doi:10.1155/2014/548272.
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Xolair

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  2. United States of America et al v. Novartis Pharmaceuticals Corp. et al., Civil Action no. 12-cv-10962-JLT, in the U.S. District Court for the District of Massachusetts. (Accessed June 2016)
  3. Institute for Safe Medication Practices (ISMP). QuarterWatch. Perspective on Drug Hypersensitivity. May 7, 2014 — Data from 2013 Quarter 1. (Accessed June 2016)
  4. Corporate Crime Reporter. Timothy Cornell and the Bumps In the Road on the Way to a False Claims Act Recovery. January 14th, 2016.
  5. Wechsler ME, Wong DA, Miller MK, Lawrence-Miyasaki L (May 2009). “Churg-strauss syndrome in patients treated with omalizumab”. Chest 136 (2): 507–18. doi:10.1378/chest.08-2990. PMID 19411292.
  6. Sheldon T. “News: Senior Dutch researcher sacked for manipulating data in rheumatoid arthritis drug trial”. BMJ 347. doi:10.1136/bmj.f5267. 23/8/2013.
  7. Chang TW, Wu PC, Hsu CL, Hung AF (2007). “Anti-IgE antibodies for the treatment of IgE-mediated allergic diseases”. Adv Immunol. 93: 63–119. doi:10.1016/S0065-2776(06)93002-8
  8. Davydov L (January 2005). “Omalizumab (Xolair) for treatment of asthma”. Am Fam Physician 71 (2): 341–2. PMID 15686303.
  9. U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events. www.fda.gov (Accessed October 2016)

Zofran

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  4. Drugs.com. “Ondansetron”. Accessed November 2015.
  5. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: nausea and vomiting of pregnancy. Obstet Gynecol. 2004; 103: 803–814
  6. Koren, G (December 2014). “Treating morning sickness in the United States–changes in prescribing are needed.”. American journal of obstetrics and gynecology 211 (6): 602–6. PMID 25151184.
  7. Elkomy, M. H.; Sultan, P.; Carvalho, B.; Peltz, G.; Wu, M.; Clavijo, C.; Galinkin, J. L.; Drover, D. R. (2015-02-01). “Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome”. Clinical Pharmacology and Therapeutics 97 (2): 167–176. doi:10.1002/cpt.5. ISSN 1532-6535. PMC 4325425. PMID 25670522.
  8. Siu, Shing-Shun N.; Chan, Matthew T. V.; Lau, Tze-Kin (2006-01-01). “Placental transfer of ondansetron during early human pregnancy”. Clinical Pharmacokinetics 45 (4): 419–423. doi:10.2165/00003088-200645040-00006. ISSN 0312-5963. PMID 16584287.
  9. Koren, G. “Scary science: ondansetron safety in pregnancy-two opposing results from the same Danish registry”. Ther Drug Monit. 2014 Jan 9
  10. Andersen, J.T., Jimmenez-Solem, E., and Andersen, N.L. “Ondansetron use in early pregnancy and the risk of congenital malformations”. Int Soc Pharmacoepidemiol. 2013; Abstract 25, Pregnancy session 1.
  11. Danielsson, Bengt; Wikner, Birgitta Norstedt; Källén, Bengt (2014-12-01). “Use of ondansetron during pregnancy and congenital malformations in the infant”. Reproductive Toxicology (Elmsford, N.Y.) 50: 134–137. doi:10.1016/j.reprotox.2014.10.017. ISSN 1873-1708. PMID 25450422.
  12. Anderka, Marlene; Mitchell, Allen A.; Louik, Carol; Werler, Martha M.; Hernández-Diaz, Sonia; Rasmussen, Sonja A. (2012-01-01). “Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects”. Birth Defects Research. Part A, Clinical and Molecular Teratology 94 (1): 22–30. doi:10.1002/bdra.22865. ISSN 1542-0760. PMC 3299087. PMID 22102545.
  13. Food and Drugs Administration (FDA). “Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between January– March 2013.” fda.gov. (Accessed November 2015)
  14. Turkel, S.B., Nadala, J.G., and Wincor, M.Z. “Possible serotonin syndrome in association with 5-HT(3) antagonist agents”. Psychosomatics. 2001; 42: 258–260
  15. Food and Drugs Administration (FDA). “FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran).” fda.gov. (Accessed November 2015) http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm
  16. Food and Drugs Administration (FDA). “FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products.”fda.gov. (Accessed November 2015).
  17. Department of Justice. (2012, July 2). “GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety data”. [Press Release]. Retrieved from: http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report
  18. Meds News. Zofran during pregnancy – the off-label prescriptions scandal. December 3, 2015
  19. Department of Justice. (2012, July 2). “GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety data”. [Press Release]. Retrieved from: http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report
  20. Drugs.com. “Ondansetron”. Accessed November 2015. http://www.drugs.com/ondansetron.html
  21. King MW. “Serotonin”. The Medical Biochemistry Page. Indiana University School of Medicine. Retrieved 1 December 2009.
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  23. Mayo Clinic. “Diseases and Conditions – Serotonin syndrome.” http://www.mayoclinic.org/diseases-conditions/serotonin-syndrome/basics/definition/con-20028946 (Accessed November 2015)
  24. Rich-Edwards JW, Kleinman K, Abrams A, Harlow BL, McLaughlin TJ, Joffe H, Gillman MW. “Sociodemographic predictors of antenatal and postpartum depressive symptoms among women in a medical group practice.” J Epidemiol Community Health. 2006 Mar; 60(3):221-7.
  25. Teixeira C, Figueiredo B, Conde A, Pacheco A, Costa R. “Anxiety and depression during pregnancy in women and men.” J Affect Disord. 2009 Dec; 119(1-3):142-8.
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  27. Freedman SB, Uleryk E, Rumantir M, Finkelstein Y. Ondansetron and the risk of cardiac arrhythmias: a systematic review and postmarketing analysis. Ann Emerg Med. 2014 Jul;64(1):19-25.e6. doi: 10.1016/j.annemergmed.2013.10.026. Epub 2013 Dec 4.
  28. Goodwin, TM (September 2008). “Hyperemesis gravidarum.”. Obstetrics and gynecology clinics of North America 35 (3): 401–17, viii. doi:10.1016/j.ogc.2008.04.002. PMID 18760227.
  29. Panoulas VF, Toms TE, Douglas KM, et al. (January 2014). “Prolonged QTc interval predicts all-cause mortality in patients with rheumatoid arthritis: an association driven by high inflammatory burden”. Rheumatology 53 (1): 131–7. doi:10.1093/rheumatology/ket338. PMID 24097136
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  31. Raymond SH. A survey of prescribing for the management of nausea and vomiting in pregnancy in Australasia. Aust N Z J Obstet Gynaecol. 2013 Aug; 53(4):358-62.
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  33. Kumar, Vinay; Fausto, Nelson; Fausto, Nelso; Robbins, Stanley L.; Abbas, Abul K.; Cotran, Ramzi S. (2005).Robbins and Cotran Pathologic Basis of Disease (7th ed.). Philadelphia PA: Elsevier Saunders. pp. 1012–4. ISBN 0-7216-0187-1.
  34. Watkins, SE; Meyer, RE; Strauss, RP; Aylsworth, AS (April 2014). “Classification, epidemiology, and genetics of orofacial clefts.”. Clinics in plastic surgery 41 (2): 149–63. doi:10.1016/j.cps.2013.12.003. PMID 24607185.
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Other articles and additional info

  1. Woodcock J, Behrman RE, Dal Pan G. Role of postmarketing surveillance in contemporary medicine. Annu Rev Med. 2011;62:1-10.
  2. Robert R. Campbell, et al. (2008). Proactive Postmarketing Surveillance: Overview and Lessons Learned from Medication Safety Research in the Veterans Health Administration. Canadian Pharmacists Journal.
  3. Carpenter D, Ting MM. Essay: The political logic of regulatory error. Nat Rev Drug Discov 2005; 4: 819-823.
  4. Paul Seligman (July 9, 2008). FDA’s Role in Identifying and Communicating Drug Safety Issues. Statement before
    the House Committee on Veterans’ Affairs. The U.S. Food and Drug Administration (FDA).
  5. Talbot JCC, Nilsson BS. Pharmacovigilance in the pharmaceutical industry. British Journal of Clinical Pharmacology. 1998;45(5):427-431. doi:10.1046/j.1365-2125.1998.00713.x.
  6. FDA Consumer Health Information (November 2012). A Guide to Drug Safety Terms at FDA. The U.S. Food And Drug Administration (FDA).
  7. American Psychiatric Association (2004) “APA Responds to FDA’s New Warning on Antidepressants,” press release, October 15, 2004, available at www.psych.org/news_room/press_releases/04-55apaonfdablackboxwarning.pdf
  8. The U.S. Food And Drug Administration (FDA). Recalls, Market Withdrawals, & Safety Alerts – Background and Definitions. www.fda.gov (Accessed November 2016)
  9. John E. Calfee, May 5, 2005. The Roles of FDA and Pharmaceutical Companies in Ensuring the Safety of Approved Drugs, Like Vioxx. The American Enterprise Institute (AEI). www.aei.org
  10. The United States Department of Justice (DOJ). January 9, 2015. Daiichi Sankyo Inc. Agrees to Pay $39 Million to Settle Kickback Allegations Under the False Claims Act. www.justice.gov (Accessed November 2016)
  11. The United States Department of Justice (DOJ). November 4, 2013. Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations. www.justice.gov (Accessed October 2016)
  12. Martin A Makary, Michael Daniel. Medical error—the third leading cause of death in the US. BMJ 2016;353:i2139
  13. Doctor behind biggest Hep C outbreak ever guilty of MURDER after patient died at his clinic where staff reused needles. July 2, 2013. DailyMail.
  14. Bal BS. An Introduction to Medical Malpractice in the United States. Clinical Orthopaedics and Related Research. 2009;467(2):339-347. doi:10.1007/s11999-008-0636-2.
  15. Gagnon M-A, Lexchin J. The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PLoS Medicine. 2008;5(1):e1. doi:10.1371/journal.pmed.0050001.
  16. Eric G. Campbell, et al. A National Survey of Physician–Industry Relationships. N Engl J Med 2007; 356:1742-1750. April 26, 2007. DOI: 10.1056/NEJMsa064508
  17. 42 U.S. Code § 1320a–7b – Criminal penalties for acts involving Federal health care programs
  18. Yeh JS, Franklin JM, Avorn J, Landon J, Kesselheim AS. Association of Industry Payments to Physicians With the Prescribing of Brand-name Statins in Massachusetts. JAMA Intern Med. 2016;176(6):763-768. doi:10.1001/jamainternmed.2016.1709
  19. The United States Department of Justice Website. False Claims Amendments Act of 1986 (P.L. 99-562). www.justice.gov (Accessed May 2017)
  20. The United States Department of Justice. Thursday, December 3, 2015. Justice Department Recovers Over $3.5 Billion From False Claims Act Cases in Fiscal Year 2015. www.justice.gov
  21. The United States Department of Justice. Monday, May 7, 2012. Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote. www.justice.gov
  22. The United States Department of Justice.Tuesday, March 11, 2014. Pharmaceutical Company To Pay $27.6 Million To Settle Claims Of False Billings To Federal And State Health Care Programs. www.justice.gov
  23. Associated Press March 30, 2005. Company News; PharMerica to pay &6 Million to settle kickback case. The New York Times.
  24. David Jackson and Gary Marx. February 26, 2010. East Coast nursing home chains settle kickback allegations. Agreement calls for $14 million paid to federal government. The Chicago Tribune.
  25. Gardiner Harris, March 1, 2016. Waste in Cancer Drugs Costs $3 Billion a Year, a Study Says. The New York Times.

Last Updated: August 10, 2017