arznei-telegramm 2002; 33: 119 |
Inadequate Information About the Cox-2 Inhibitor Parecoxib (DYNASTAT) Two and a half weeks after Pharmacia stopped the sale of the Cox-2 inhibitor parecoxib (DYNASTAT), the company is telling professionals about "important new safety information" (1). Life-threatening hypersensitivity disorders have been documented in association with valdecoxib (USA: BEXTRA), the active metabolite of parecoxib, such as anaphylaxis, angioedema, erythema multiforme, exfoliative dermatitis, STEVENS JOHNSON syndrome and toxic epidermal necrolysis (LYELL syndrome). Parecoxib and valdecoxib are sulphonamide derivatives. Some of the adverse reactions affect patients with known sulphonamide allergy. Sulphonamide allergy is therefore now listed as a contraindication (1). The process has revealed deficiencies in competency among manufacturers and the European licensing authorities with regard to preventive consumer protection:
CONCLUSION: in view of the danger of severe hypersensitivity reactions and the paradox listing of "treatment of postoperative pain" as an indication we once again caution against the use of the Cox-2 inhibitor parecoxib (DYNASTAT). |
1 | Pharmacia: Circulated to professionals, Oct. 2002 (Entry 25. Oct. 2002) |
© arznei-telegramm 11/02 |