Bextra

FDA: November 15, 2002

FDA and Pharmacia are advising health care professionals about new warnings and information in the product labeling of the drug Bextra (valdecoxib), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). The labeling is being updated with new warnings following postmarketing reports of serious adverse effects including life-threatening risks related to skin reactions -- including Stevens Johnson Syndrome, and anaphylactoid reactions (serious allergic reactions). In addition, the labeling will state that the drug is contraindicated -- not to be used -- in patients allergic to sulfa containing products.

On November 13, 2002, Pharmacia, the manufacturer of Bextra sent letters to health care professionals advising them of postmarketing reports and new warnings that will be included in the drug label. Since the firm began marketing the drug in March of 2002, cases of the serious skin and hypersensitivity reactions have been reported. These included cases of Stevens Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme. Although these adverse events are rare, some of these patients required hospitalization. Based on these reports, FDA has approved labeling changes for Bextra that include a warning for serious skin reactions. As these reactions can be life threatening, people who start Bextra and experience a rash should discontinue the drug immediately.

Health care professionals are encouraged to report any unexpected adverse or serious events associated with the use of Bextra directly to Pharmacia Corporation, Peapack, N.J. at 1-800-323-4204 or to the FDA MedWatch program at 1-800-FDA-1088.

Notice from Manufacturer
November 13, 2002

Dear Healthcare Professional,

Pharmacia and Pfizer would like to inform you about recent changes to the product labeling for BEXTRA® (valdecoxib tablets). BEXTRA is indicated for relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis, and for the treatment of primary dysmenorrhea.

Since BEXTRA was approved by the FDA on November 16, 2001, in postmarketing experience, rare spontaneous reports of hypersensitivity reactions (i.e., anaphylactic reactions and angioedema) and skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme, have been received for patients treated with BEXTRA.

These cases, some of which were serious/life-threatening, have occurred in patients with and without a history of allergic-type reactions to sulfonamides.

WARNINGS - Serious Skin Reactions: Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported through post-marketing surveillance in patients receiving BEXTRA (see ADVERSE REACTIONS - Postmarketing Experience). As these reactions can be life threatening, BEXTRA should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

WARNINGS - Anaphylactoid Reactions: In post-marketing experience, cases of hypersensitivity reactions (anaphylactic reactions and angioedema) have been reported in patients receiving BEXTRA (see ADVERSE REACTIONS - Postmarketing Experience). These cases have occurred in patients with and without a history of allergic-type reactions to sulfonamides (see CONTRAINDICATIONS).

ADVERSE REACTIONS - Postmarketing Experience: The following reactions have been identified during postmarketing use of BEXTRA. These reactions have been chosen for inclusion either due to their seriousness, reporting frequency, possible causal relationship to BEXTRA, or a combination of these factors. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General: Hypersensitivity reactions (including anaphylactic reactions and angioedema).
Skin and appendages: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis.

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