Celebrex to carry black box warning

Apart from announcing that Pfizer will recall Bextra, the US Food & Drug Administration (FDA) also announced that it has asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has also agreed to work with FDA on the boxed warning for Celebrex. (Related article: Bextra recall announced)

This decision was expected since a series of studies had shown that Celebrex had serious side effects. After Vioxx recall was announced by Merck in September 2004, several doctors and consumer groups had demanded a recall of Celebrex as well. A FDA panel agreed in February 2005 that Celebrex had severe side effects but it had some benefits, and therefore, should be allowed to stay on the market with a black-box warning (the most serious warning on an approved drug in the United States).

Since early reports of Celebrex side effects started to pour in late last year, Americans have continued to abandon Celebrex. While the company saw a huge increase in sales after the recall of Vioxx, there was an equally steep drop in sales after the data on side effects were published. During this saga, Pfizer, however, continued to stand by the safety of Celebrex. The FDA also warned Pfizer for misleading ads related to Celebrex.

In an announcement, Pfizer said today it will work with the FDA to add expanded risk information in the Celebrex label following an FDA decision to require boxed warnings of potential cardiovascular risk for all COX-2 pain relievers and all NSAIDs, including older non-specific drugs such as ibuprofen and naproxen (Aleve).

Pfizer and the FDA plan further discussions regarding the precise content of the Celebrex label. Pfizer says that it has accumulated extensive Celebrex clinical data over the past 10 years involving more than 40,000 patients. Pfizer also reaffirmed its commitment to conduct additional long-term clinical studies evaluating the benefits and risks of Celebrex. Pfizer also said it will work closely with the FDA to develop a guide to assist patients and their healthcare professionals in making the best decisions for treating their arthritis pain.

FDA is allowing Celebrex to remain on the market on the condition that Pfizer take the actions listed below.

• Revise the Celebrex label to include a boxed warning containing the class NSAID warnings and contraindication about cardiovascular and gastrointestinal risk, plus specific information on the controlled clinical trial data that demonstrate an increased risk of adverse CV events for celecoxib, and encourage prescribers to discuss with patients the potential benefits and risks of Celebrex and other treatment options before a decision is made to use Celebrex.
• Encourage practitioners to use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Include a Medication Guide as part of the labeling. It will be required to be given at the time the drug is dispensed to inform patients of the potential for CV and GI risk associated with NSAIDS, in general, and Celebrex specifically. The Medication Guide will inform patients of the need to discuss with their doctor the risks and benefits of using NSAIDs and the importance of using the lowest effective dose for the shortest duration possible.
• Commit to conduct a long-term study to address the safety of Celebrex compared to naproxen and other appropriate drugs. FDA will work with Pfizer to design this long-term study and ensure its timely initiation and completion.

Finally, the FDA is advising patients, who are taking CELEBREX, that they should discuss questions or concerns about this new information with their physician.

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