FDA Watch List: Proton Pump Inhibitors

The Food and Drug Administration released its most recent list of drugs that consumers and health professionals should keep their eye on due to serious risks or new safety information.

One of the drugs on this quarterly list includes Proton Pump Inhibitors ( PPIs) is a class of drugs used to treat stomach and small intestine ulcers, gastroesophageal reflux disease (GERD) and inflammation of the esophagus. Some PPIs include Nexium (esomeprazole), Prilosec (omeprazole) and Prevacid (lansoprazole).

PPIs found its way onto the watch list because patients who take the drugs may experience clostridium difficile- associated diarrhea. Clostridium difficile is a bacterium that may cause diarrhea and its symptoms include watery stool, fever and abdominal pain. The FDA is evaluating this issue to determine if regulatory action is necessary.

The FDA used the information from the Adverse Event Reporting System (AERS) database from October to December 2011 to identify the new hazards and safety data for the drugs. An appearance of a medication on the list is an indication that there is a potential safety issue, but does not mean there is a cause and effect relationship between the drug and risk.

If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law for a free legal consultation and to find out if a dangerous drug lawyer may be able to help you.

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