The consumer watchdog group Public Citizen has filed a lawsuit against the U.S. Food and Drug Administration (FDA), in an effort to force the agency to include black box warnings on the labels of proton pump inhibitors like Nexium, Prevacid and Prilosec, notifying consumers about the serious health risks allegedly tied to the heartburn medications. In the lawsuit, which was filed in Washington D.C. on April 30, Public Citizen seeks to require the FDA to respond to a petition calling for more stringent warnings on the drugs commonly used to reduce the production of gastric acid. If you have suffered a serious side effect you believe to be related to the use of a proton pump inhibitor like Prevacid, Prilosec or Nexium, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a reputable attorney who has experience handling drug injury claims.
Heartburn drugs like Prilosec and Nexium are used by millions of Americans to reduce the amount of acid in the stomach and treat heartburn, gastroesophageal reflux disease, ulcers in the small intestines and stomach, and inflammation of the esophagus. However, serious concerns have been raised about the safety of the medications, in light of the risk of possible side effects, including bone fractures, infections, cardiovascular disease, pneumonia and more. The FDA required makers of heartburn drugs to update their warning labels in 2010, highlighting information about a potential risk of bone fractures and bone problems linked to the medications. This warning was updated again in 2011, indicating that the risk of bone fractures from Nexium use appears to be associated with high doses of the drug used over long periods of time.
According to Public Citizen’s complaint, the FDA has illegally ignored for nearly three years a petition filed by the organization in August 2011. In the petition, the consumer watchdog group argues that Nexium, Prilosec and other heartburn drugs should carry black box warnings, the strongest warning possible issued by the FDA, highlighting the risk of serious side effects linked to the medications, as well as a risk of chemical dependency. Members of Public Citizen indicate that patients who use proton pump inhibitors for more than a month and then discontinue treatment suffer from stomach acid levels that are higher than their levels prior to treatment. This may cause some patients to begin treatment again to combat these adverse effects, possibly resulting in drug dependence.
In addition to the complaint filed against the FDA by Public Citizen, a number of former users of the heartburn drugs who have suffered serious side effects are now pursuing lawsuits against the makers of the medications, alleging that the drug firms failed to adequately warn the public about the risks associated with long-term use of the drugs. If you believe you have been adversely affected by side effects of a potentially dangerous pharmaceutical drug, contact a reputable drug injury attorney today to discuss your legal options. You may have grounds to file a product liability lawsuit against the drug manufacturing company, in order to pursue financial compensation for your injuries and medical expenses.