Despite its numerous risks and dangers, Johnson & Johnson decided to move forward towards expanding the market for the antidiabetes drug Invokana. The controversial medication is, in fact, associated with many serious side effects such as kidney failure, increased risk of amputations, urinary tract infections and pancreatitis. Despite that, the pharmaceutical company still filed a new supplemental new drug application (SNDA) to the Food and Drug Administration (FDA), hoping to receive approval for a new indication.

According to the results of the CANVAS trial published in June in the New England Journal of Medicine, Invokana could be used to reduce the risk of strokes and heart attacks in type-2 diabetes patients. The obvious consequence would be to expand the current medication’s market to a large number of additional people since diabetic individuals are frequently at risk of cardiovascular issues. Experts estimated that the drug’s sales could reach up to $1.7 billion over the next seven years.

However, Invokana is all but a safe medication. A large controversy that included even allegations of a potential off-label marketing scandal is centered around this antidiabetes agent. Almost one thousand lawsuits have been filed by disgruntled plaintiffs who had to suffer the serious or potentially fatal complications of this allegedly poorly tested drug. Many who received a canagliflozin prescription, in fact, are facing life-long damage after they suffered kidney failures and diabetic ketoacidosis. As the number of civil actions filed against J&J kept increasing, the Judicial Panel on Multidistrict Litigation (JPML) decided to centralize them all in the new MDL Products Liability Litigation No. 2750 in the U.S. District of New Jersey court. Plaintiffs argue that the manufacturer failed to adequately warn the public about Invokana’s dangers, and released a defective and dangerous product to the market.

Back in May 2017, the FDA already issued a safety announcement warning the public about an increased risk of foot and leg amputations associated with the use of all medications which contained canagliflozin (Invokana and Invokamet). The level of alert was so high, that the regulator required a new black box to be added to the drug’s label. Every patient who started developing pain, infections, sores or ulcers in the lower limbs was advised to immediately seek a healthcare professional to check whether the antidiabetes medication had to be stopped or switched. The announcement came as a consequence of the copious evidence about Invokana’s dangers provided recently by two large clinical trials.

Article by Dr. Claudio Butticè, Pharm.D.