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FDA Orders Stronger Warnings to Proton Pump Inhibitor (PPI) Heartburn Medications

Nov 7, 2014

The U.S. Food and Drug Administration (FDA) has ordered that the warning labels on certain acid reflux and heartburn medications be strengthened, more than three years after the advocacy group, Public Citizen, petitioned the agency for changes.

The label and prescribing information for certain proton pump inhibitors (PPIs), including Nexium, Protonix, and Dexilant, will be changed to warn consumers about antibiotic-associated diarrhea and interactions with other drugs, the Wall Street Journal blog “Pharmalot” reports. But the FDA did not require Black Box warnings, the most serious label warning, which the Public Citizen petition called for. The agency indicated that the adverse effects cited in the petition—antibiotic-associated diarrhea, osteoporotic fractures, low magnesium in the blood—were not serious enough or frequent enough to warrant a Black Box warning.

In its petition, Public Citizen noted the widespread use of proton pump inhibitors. By last year, about 131 million prescriptions had been written, according to the WSJ, and many more people take over-the-counter versions of these medications. The group has also maintained that the drugs are often prescribed off-label, that is, for conditions for which the drugs were not approved to treat. Given such widespread use, Public Citizen was concerned that the FDA had not responded more quickly to its petition. In April the consumer group filed a lawsuit to prod FDA officials to act.

Public Citizen senior advisor, Sidney Wolfe, said that label changes now ordered by the FDA “are important and will make the products safer,” the WSJ reports, but the FDA had “unreasonably delayed, endangering millions of patients.” The evidence, Wolfe said, was available more than three years ago.

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