The U.S. Food and Drug Administration (FDA) is updating the warning label on medicines used to treat acid reflux and heartburn, such as Nexium, Protonix and Dexilant, to reflect the risk of antibiotic-associated diarrhea and interactions with other medications. According to The Wall Street Journal, the action comes three years after consumer advocacy group Public Citizen petitioned for the change.
In April 2011, Public Citizen petitioned the FDA to place a black box warning on several proton pump inhibitors to warn about antibiotic-associated diarrhea and interactions with some other medications. While the agency did not acquiesce the black box warning, it has decided to add information on the labels of several proton pump inhibitors. The FDA also intends to mandate medication guides for some of the drugs, which are sold over-the-counter.
A black box warning is the FDA’s most serious warning. Public Citizen argued that this was necessary given that PPIs are so commonly used. The group said in its 2011 petition that roughly 119 million prescriptions were dispensed in the US in 2009. The number went up to 131 million by last year. These drugs are also frequently used for unapproved uses, the group pointed out.
In a statement, Public Citizen senior advisor Sid Wolfe said “Although we are disappointed in the rejection of certain requests, the portions of the petition granted by the agency are important and will make the products safer,”
The group was unsatisfied with how long the FDA had taken to respond, and filed a lawsuit last April to push the agency into action. It is uncertain whether or not the recent change was influenced by the lawsuit.
“At the same time, 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.” Wolfe stated.
An FDA spokeswoman told WSJ “FDA needed to ensure any action by the agency is supported by the available science for each product and each indication. This type of review for an entire class of products is complex and time-consuming. Also, as discussed in the petition response, FDA independently reviewed and began the process of requesting labeling changes for some of the risks discussed in the petition. Some of the labeling changes at issue were addressed in late 2011 and 2012.”