FDA Sued For Not Warning of Nexium, Prilosec Health Risks

The prominent consumer watchdog group Public Citizen has filed a lawsuit against the U.S. Food and Drug Administration, seeking to force the agency to add black box warnings to Nexium, Prilosec, and other proton pump inhibitor medications, highlighting potentially serious health risks associated with the popular heart burn drugs.  

In a lawsuit filed in federal court in D.C. on April 30, Public Citizen seeks declaratory and injunctive relief to require the FDA to respond to a petition calling for stronger warnings on the stomach acid reducing drugs. According to the complaint (PDF), the FDA has illegally ignored a Public Citizen petition for more than two and half years.

Proton pump inhibitors (PPIs) reduce the amount of acid in the stomach and are used to treat gastroesophageal reflux disease (GERD), as well as heartburn, ulcers in the stomach and small intestines, as well as inflammation of the esophagus.

The medications are used by millions of Americans, but Public Citizen indicates that inadequate information is being provided about the potential health risks, which may include infections, bone fractures, increased risk of pneumonia, cardiovascular disease and dependency issues, where patients who stop taking the drug make even more stomach acid than before they started the treatment. This may cause acid reflux symptoms to return even worse than before the medication was used, which Public Citizen indicates is particularly worrisome since a large number of patients are given the medications when they are not even needed in the first place.

Nexium is the most widely used medication from this class, generating an estimated $6 billion in annual sales. Other drugs in this class include Prevacid, Prilosec, Protonix, Zegerid, Aciphex and Vimovo, with many now available in over-the-counter formulations.

The FDA forced the manufacturers of Nexium and all other proton pump inhibitor (PPI) medications to update the warning labels in 2010, adding information about a potential risk of risk of fractures and bone problems associated with use of the medications.

That warning was updated again by the FDA in 2011, indicating that the risk of broken bones from Nexium appears to be linked to high doses of the medication used over long periods of time, which is exactly the kind of prescribing behavior the study found happens far too often.  Over-the-counter versions of the drug did not appear to be affected, according to federal drug regulators.

In August 2011, Public Citizen filed a petition for the drugs to carry the strongest warning possible, a black box warning, alerting users to the risk of a number of side effects as well as a risk of chemical dependency.

Public Citizen indicates that patients who use the drugs for more than a month and then stop taking them suffer from levels of stomach acid that exceed the levels they had before they started PPI treatment. The increased acid often results in patients going back on Nexium, Prilosec or a similar drug to combat the even stronger acid levels, resulting in drug dependence.

About six months after the petition was filed, the FDA issued a warning that PPIs were linked to an increased risk of serious bacterial infection. However, in April 2012, the FDA wrote back to Public Citizen indicating that their request raised complex issues and needed a major review before a decision on the petition could be reached.

“These drugs are habit-forming, dangerous and overprescribed, but the FDA hasn’t properly warned consumers,” Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group, said in a press release announcing the lawsuit. “The agency has had more than two and a half years to respond to our petition. Meanwhile millions of people are taking these drugs without adequate warnings. The urgency of our petition is that only with these additional, serious warnings, will unnecessary PPI use decrease rather than continually increase.”

In addition to Public Citizen’s complaint, a number of former users who have suffered bone fractures are now pursuing a Nexium Lawsuit, alleging that AstraZeneca failed to adequately warn about the risks associated with long term use of the heartburn drug.

In December 2012, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a Nexium bone fracture MDL, consolidating at least 47 injury lawsuits filed in U.S. District Courts throughout the United States.  Many of those complaints also contain a large number of individual plaintiffs.