The U.S. Food and Drug Administration (FDA) will require stronger warnings regarding risks associated with Nexium, Prilosec and other popular heartburn drugs. The FDA concluded that doctors and patients should know more about potential drug interactions and side effects. The agency’s action, disclosed Nov. 7, was a response to a 2011 petition from Public Citizen. The consumer advocacy group sued the FDA in April seeking to force regulators to address the petition’s concerns. Although Public Citizen’s petition was granted in several respects, the FDA rejected an important request in the petition Public Citizen wanted black box warnings. Instead, the FDA concludes that standard labeling sections relating to new risks are adequate. Public Citizen, in a statement, had this to say:

The FDA’s actions are important and will make the products safer but also took far too long. 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.

In addition to Nexium and Prilosec, the FDA’s action has implications for other so-called proton pump inhibitors (PPIs), including Protonix, Prevacid, Dexilant, Zegerid and Aciphex, as well as any generic versions of those products. PPIs are widely used – Nexium alone racked up sales of roughly $6 billion last year – and are sold in different forms both over the counter and by prescription.

One of the new warnings addresses possible interactions between PPIs and cancer drug methotrexate that can cause the latter product to remain in patients longer than usual and have a toxic effect. FDA officials wrote:

We agree that the potential drug-drug interaction between methotrexate and PPI drugs poses a safety risk and should be reflected in the labeling of all PPI products.

The FDA said further that labels for prescription products have been updated and will be revised in the future for OTC pills. Separately, the FDA said labels have been updated to reflect drug interaction risks between heart attack drug Plavix, or clopidogrel, and several PPIs. The concern in those instances is that clopidogrel’s blood-thinning effects can be inhibited by PPIs, whose active ingredients include esomeprazole, omeprazole and pantoprazole, among others. In another area, FDA officials agreed that the acid-reducing effects of PPIs can sometimes lead to excess bacteria accumulating in the digestive system. That raises the risk of serious infections involving a bacterium called Clostridium difficile, and the FDA said that labeling will be updated accordingly.

But the FDA did refuse to add new information about pneumonia risk associated with PPI-linked bacterial overgrowth, finding that the “risk and causal association are not well-established” between the two. On another front, the FDA also agreed to take steps regarding PPI-related risks of vitamin B12 deficiency and a kidney disorder called acute interstitial nephritis. Medication guides also will be issued along with some PPIs to disclose their risks.

On several additional fronts the FDA rejected Public Citizen’s requests. One of the requests involved the group’s argument in favor of black box warnings discussing the risk of bone fractures when using PPIs. The FDA made this interesting response, saying there is a “lack of data on fatal outcomes related to PPI use and bone fractures,” as well as a “relatively low magnitude of risk.” Regulators also rejected requests for new warnings related to rebound effects that Public Citizen said can occur when PPIs are discontinued after more than one month of use. Also, the FDA declined to require new “dear doctor” letters informing health care providers of revised risks.

Frankly, I would put Public Citizen’s record on safety issues involving drugs up against that of the FDA. Making that comparison, there can be little question about which of the two comes out on top. Public Citizen has clearly been head and shoulders above the FDA. All you have to do is take a look at the number of drugs that were approved and placed on the market by the FDA over the strong objection of Public Citizen. Vioxx, the pain killer, is a prime example.


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