FDA adds language to GERD drugs
Certain proton-pump inhibitors, including Nexium, Protonix and Dexilant will sport new warnings regarding antibiotic-associated diarrhea and drug interactions.
The Wall Street Journal reports that the FDA's actions have been three years in the making — advocacy group Public Citizen filed a citizen's petition lobbying for such a change back in 2011. Public Citizen also wanted a black-box warning, but the Journal notes the FDA has set that request aside, saying that potential problems associated with these medications, which may also include low magnesium and osteoporitic fractures, happened too infrequently to require such a dire warning. The FDA has not yet told the Journal why it took three years to make a move.