Nexium and Prilosec

The dangerous consequences of using PPIs

Proton pump inhibitors are used for a wide range of gastrointestinal conditions such as heartburns, peptic ulcers, Zollinger-Ellison syndrome (ZES), and gastroesophageal reflux disease (GERD). They are also often used in combination with long-term nonsteroidal anti-inflammatory drugs (NSAIDs) treatment to prevent these medications from causing gastric bleeding. PPIs are very potent medications that act by reducing the production of hydrochloric acid in the stomach by up to 99%. Other antacid drugs such as the H2 antagonists (Tagamet, Pepcid, Zantac) are not so powerful and effective, but they’re much less dangerous as well. An adequate production of gastric acid is, in fact, crucial for our well-being. A prolonged suppression of stomach secretion increases the exposure to several strains of bacteria and microbes that usually die in the sterilizing acid medium of the gastrointestinal tract. Severe pneumonia, enteritis, and recurrent diarrhea are just some of the infections caused by Clostridium difficile and other microbes found in the food we eat. Long-term gastric acid suppression may also lead to malabsorption of many important nutrients such as Vitamin B12, causing pernicious anemia, hypomagnesemia, reduction of bone strength and increased risk of fractures. Hypochlorhydria is also linked to hypergastrinemia (excess production of a hormone called gastrin), a condition which may increase the risk of gastric tumors and other cancers.

Many patients filed a litigation after they suffered from a potentially lethal interstitial nephritis, an acute consequence of using esomeprazole. AstraZeneca never properly warned the public about this side effect, whose consequences may include permanent kidney damage, renal transplant or dialysis. A study published in the JAMA Internal Medicine journal found evidence that patients who took higher doses of this drug were associated with a 20 to 50 percent increased risk of chronic kidney disease (CKD). Another large study (the PLOS-ONE) found that PPIs may increase the risk of cardiovascular failure by up to 21 percent by damaging the internal lining of blood vessels, leading to the formation of lethal blood clots. Finally, a research published in the journal JAMA Neurology found an association between the use of these drugs and a 50 percent increased risk of dementia in elderly patients.

Additional warnings and label changes

Prilosec and Nexium’s labels have been updated by the FDA many times since they were released to the market. The regulator found that these two drugs were associated with many new risks and slowly warned the public about them over the course of the last 15 years. These warnings include:

• A drug interaction between Prilosec and the anticoagulant drug Plavix (clopidogrel), whose effectiveness may be halved with lethal consequences (2009)
• An increased risk of wrist, spine, and hip fractures (2010)
• A risk of hypomagnesemia (low magnesium levels) with long-term use of PPIs (2011)
• A new adverse reaction: microscopic colitis and Clostridium difficile-associated diarrhea (2012)
• A toxic drug interaction between Proton pump inhibitors and the antimetabolite Methotrexate (2012)
• A risk of acute interstitial nephritis as and of malabsorption leading to Vitamin B12 deficiency (2014)