New FDA Labeling for Pfizer’s Celebrex, Pfizer Agrees to Suspend Sales of Bextra

Pfizer Separately Agrees to Suspend Sales of Bextra Due to FDA Evaluation of Risks of Rare But Serious Skin Reactions

Pfizer said it will work with the U.S. Food and Drug Administration (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.

The boxed warning for all non-steroidal anti-inflammatory drugs (NSAIDs), including Celebrex, will also contain information regarding gastrointestinal risk.

In addition, the FDA is asking manufacturers of all over-the-counter NSAIDs to revise their labeling to include more information on the cardiovascular and gastrointestinal risks as well as a warning about potential skin reactions.

Pfizer and the FDA plan further discussions regarding the precise content of the Celebrex label. Pfizer 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.

Regarding Bextra, Pfizer’s other oral Cox-2 inhibitor, the FDA informed Pfizer late yesterday that, in the agency’s view, Bextra’s cardiovascular risk could not be differentiated from other NSAIDs. However, the agency has concluded that the additional, increased risk of rare but serious skin reactions associated with Bextra, already described in its label, warrants its withdrawal from the market.

Pfizer respectfully disagrees with FDA’s position regarding the overall risk/benefit profile of Bextra. However, in deference to the agency’s views, the company has agreed to suspend sales of the medicine pending further discussions with the FDA. Pfizer said it will explore options with the agency under which the company might be permitted to resume making Bextra available to physicians and patients. For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options.

SOURCE: Pfizer Inc

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FACT:
Testosterone deficiency, is a common complication of diabetes: Low testosterone production appears to be common in men with Type 2 diabetes; a study found one in three men with diabetes are affected. The results of the study indicate that this condition, known as hypogonadism, is provoked not by a defect in the testes, where testosterone is produced, but by the impaired functioning of the pituitary gland, which controls production of testosterone, or of the hypothalamus, the region of the brain that controls the pituitary. Testosterone deficiency has not been recognized as a complication of Type 2 diabetes, and researchers said the high prevalence of 30% was unexpected. Low testosterone in men with diabetes, in addition to lowered libido and erectile dysfunction, is associated with the loss of muscle tone and bone density, an increase in abdominal fat, and can affect mood and cognition.
(J Clin Endocrinol Metab 2004; 89: 5462-8).