More than three years after the consumer advocacy group Public Citizen petitioned the Food and Drug Administration (FDA) to strengthen warnings on certain acid reflux and heartburn medications, the agency has ordered drug makers to revise label language to reflect the safety concerns.
Language will be added to the labels of several proton pump inhibitors, including Nexium, Protonix and Dexilant, to warn about antibiotic-associated diarrhea and interactions with other drugs. The agency also plans to require medications guides for some, but not all of the drugs, some of which are sold over-the-counter, the Wall Street Journal blog Pharmalot reports. But the FDA declined to require Black Box warnings, the most serious label warning. In its response, the FDA said it believes the afflictions cited in the petition – antibiotic-associated diarrhea, osteoporotic fractures, low magnesium – were not serious enough or frequent enough to warrant a Black Box warning.
In arguing for stronger warnings, Public Citizen noted how widely used proton pump inhibitors are. At the time the petition was filed, the group noted that about 119 million prescriptions had been written in the U.S. By last year, that number had reached about 131 million prescriptions, according to the WSJ. Given the widespread use of prescription and OTC forms of these drugs, Public Citizen was concerned that the FDA had not responded to its petition and in April the consumer group filed a lawsuit to prod FDA officials to act.
In a statement, Public Citizen senior advisor Sidney Wolfe said that although the group is “disappointed” that the FDA rejected some of its requests, the changes the label changes granted by the FDA “are important and will make the products safer,” the WSJ reports.