Another generic version of Nexium (esomeprazole) just hit the U.S. market despite the known dangers of this heartburn medication. The pharmaceutical company Perrigo PLC just received approval from the Food and Drug Administration (FDA) to distribute the proton pump inhibitor (PPI) to groceries and drug stores across the whole country. Differently from other generics previously marketed by other manufacturers, the latest one is the first to get approved as an over-the-counter (OTC) medication.

Prior to Perrigo, both Teva Pharmaceutical and Ranbaxy already cashed in Nexium’s popularity. AstraZeneca did, in fact, earned over $14 billion in sales during just the first five years after the drug was released. The three companies fought a long battle, however, since they all wanted market exclusivity. Teva eventually won and started distributing its own version of esomeprazole in January 2015. Today, Nexium’s sales have plummeted to just $300 million a year, but the drug is now distributed by Pfizer after the patent expired.

Despite the amazing amount of money this anti-ulcer medication is still able to provide to its manufacturers, many safety concerns have been raised about it. Together with Prilosec, another extremely similar drug, Nexium’s label has been modified by the FDA several times over the course of the last decade. The regulatory agency did, in fact, warn the public several times about its dangers by adding several black boxes, alerting the public about serious side effects such as permanent kidney damage, heart failure and bone fractures.

Several patients who suffered from the severe adverse reactions of the PPIs, claim they have not been sufficiently warned by the manufacturers and pursued a civil action against them. After many lawsuits were filed in courts all across the U.S., the Judicial Panel on Multidistrict litigation, decided to consolidate them all in an MDL this past August. Plaintiffs and their lawyers allege that failing to properly disclose the potential dangers of this drugs exposed them to unnecessary risks, and are now seeking for financial compensation. In the meanwhile, PPIs remain among the most over-utilized and over-prescribed drugs of all times.

Article by Dr. Claudio Butticè, Pharm.D.