Cardiovascular Risk and Drug Withdrawal; Dermatological Reactions
Cardiovascular Risk and Drug Withdrawal
FDA has concluded that the overall risk versus benefit profile is unfavorable and has requested that Pfizer, the manufacturer of Bextra, voluntarily withdraw Bextra from the market. This request is based on:
- The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.
- Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.
- Lack of any demonstrated advantages for Bextra compared with other NSAIDs.
Serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) have been reported in patients receiving this drug. Some of these reactions have resulted in death.
- Patients appear to be at a higher risk for these events within the first 2 weeks of treatment but effects may occur any time during treatment. Reported rates of these serious skin events appear to be higher with valdecoxib when compared to other COX-2 inhibitors
- The drug should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
FDA and Industry Communications
Patient Counseling Information