A Saga dos Pain Killers, continua
A Food and Drug Administration (FDA), pediu à Pfizer para retirar o Bextra, (Valdecoxib) do mercado, por considerar que os benefícios deste medicamento são menores do que os malefícios (link).
Recentemente, um painel do FDA votou 31-1 a favor da manutenção do Celebrex (Pfizer) no mercado, 17-13, com duas abstenções, decidiu a manutenção do Bextra (Pfizer) e 17-15 foram a favor de que o Vioxx (Merck) voltasse ao mercado.
Estas constantes "alterações de humor" do FDA não abonam nada a favor da saúde dos utilizadores.
2 Comments:
Pfizer Inc. agreed today to suspend sales of its painkiller Bextra at the request of the Food and Drug Administration, which also said it was instructing drug makers to better warn patients of the health risks of other widely used painkillers in the same class.
Pfizer said it disagreed with the government's position on the risks from Bextra, used to treat arthritis and similar ailments. But said it would suspend marketing of Bextra pending discussions with the F.D.A. and added that patients should stop taking the drug.
BEXTRA (valdecoxib tablets)
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.
Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency.
Patients currently taking Bextra should contact their physicians to consider alternative treatments.
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