Recent FDA Actions on NSAIDS (June 2005)

On April 7, 2005, FDA announced several important changes that pertain to the marketing of non-steroidal anti-inflammatory drugs (NSAIDs). FDA has asked that one product be withdrawn from the market, and is requiring stronger warnings in the labeling for the other products.

This is a continuation of the process that began several months ago with Vioxx (rofecoxib), when Merck withdrew that product from the market because of concerns about adverse cardiovascular events. These later actions are being taken because of concerns about other NSAIDs.

It's important to understand that the new actions don't just apply to the COX-2 selective inhibitors. They apply to both the COX-2 inhibitors and to other, non-selective NSAIDs, and they apply to both prescription and non-prescription products.

FDA asked the manufacturer of one of the COX-2 inhibitors, Bextra (valdecoxib), to withdraw it from the market based on concerns about cardiovascular events, and serious skin reactions.

In its decision about Bextra, FDA noted the lack of adequate data on the cardiovascular safety of this drug when it's used chronically, and also reports of serious skin reactions, including deaths. Another factor was the lack of demonstrated advantages of Bextra over other NSAIDs.

That leaves just one COX-2 inhibitor, Celebrex (celecoxib), still on the market. FDA decided that the benefits of Celebrex outweigh the risks, provided that patients are properly selected and informed. But FDA is requiring that certain actions be taken to minimize the risk with Celebrex.

For example, there will be a boxed warning in the labeling about CV and GI risks, and the labeling will encourage physicians to discuss benefits and risks with the patient. In addition, a Medication Guide will be given to the patient each time the drug is dispensed, informing them of the risks and the importance of using the lowest effective dose for the shortest time possible.

Non-selective NSAIDs, such as ibuprofen and naproxen, are also subject to new requirements. For prescription-only products, the requirements are similar to those for Celebrex, including the boxed warning in the labeling and the Medication Guide for patients. For OTC products, FDA is asking manufacturers of ibuprofen, naproxen and ketoprofen to change their labeling to give more information on CV and GI risks and provide other warnings.

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• Vioxx
• (rofecoxib)
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• (valdecoxib)
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