FDA to Add Warnings on Heartburn Drugs Like Nexium

November 6, 2014 — Three years after a consumer advocacy group filed a petition demanding a “Black Box” warning, the FDA has agreed to update the warning labels on heartburn drugs like Nexium.

In April 2011, the D.C.-based group Public Citizen called for the FDA to place its strongest boxed warning on several drugs in the proton pump inhibitor (PPI) class, including Nexium, Dexilant, Prilosec, Segerid, Prevacid, Protonix, Aciphex, Vimovo, and generics.

In a response letter (PDF), the FDA rejected calls for a “Black Box” warning about the risk of bone fractures. They also refused to add warnings about the pneumonia risk associated with bacterial overgrowth, finding that the causal association was not well-established.

However, the FDA agreed that the drugs need new safety warnings, including:

• Clostridium difficile-associated diarrhea
• Vitamin B12 deficiency
• Acute interstitial nephritis
• Recommended treatment length for gastroesophageal reflux disease (GERD)
• Drug interactions with methotrexate (a cancer drug that can remain in the body and become toxic), mycophenolate mofetil, and clopidogrel

Public Citizen said the label updates are important and will make the products safer, but criticized the length of time it took the FDA to respond. The group filed a lawsuit in April to push the FDA to respond. Sid Wolfe, senior advisor, said:

“It is unconscionable that the agency took more than three years to respond. The evidence for all of the warnings now granted was available more than three years ago, but the agency unreasonably delayed, endangering millions of patients.”

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