Jane S. Ricciuti, RPh, MS

Disclosures

December 27, 2002

In This Article

Nonsteroidal Anti-inflammatory Agents

Bextra
(valdecoxib) Tablets

Manufacturer: Pharmacia Corporation

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 11/1/02)

The product labeling was changed to strengthen the Contraindications, Warnings, and Adverse Reactions sections of the prescribing information for Bextra (valdecoxib).

Indication: Bextra (valdecoxib) is used for analgesic and anti-inflammatory effects in the symptomatic treatment of osteoarthritis in adults.

Contraindications: The following sentence was added to the Contraindications section of the product labeling:

  • Bextra should not be given to patients who have demonstrated allergic-type reactions to sulfonamides.

Warnings: The Warnings section was added to inform about serious skin reactions and anaphylactoid reactions.

  • Serious Skin Reactions
    Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported through postmarketing surveillance in patients receiving Bextra. As these reactions can become life-threatening, Bextra should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

  • Anaphylactoid Reactions
    In postmarketing experience, cases of hypersensitivity reactions (anaphylactoid reactions and angioedema) have been reported in patients receiving Bextra. These cases have occurred in patients with and without a history of allergic-type reactions to sulfonamides.

Adverse Reactions: Additional information was added explaining the new contraindications and warnings to the Bextra labeling.

  • 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.

Reference

Bextra (valdecoxib) Tablets Letter

Medscape DrugInfo

Bextra (valdecoxib) Tablets

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