Summary

The FDA has asked Pfizer to add a "black box" warning to Celebrex, warning doctors and consumers of possible complications associated with the drug. Dr. David Graham, a scientist working for the FDA, has said that the FDA should have banned Celebrex in high dosages.

Original source:
http://www.iol.co.za/index.php?set_id=14&click_id=117&art_id=qw1112934065379B243

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• Washington - A prominent consumer advocate and an outspoken FDA scientist welcomed the suspension of Pfizer's painkiller Bextra, but said some or all doses of its related drug, Celebrex, also should be suspended from the market.
• On Thursday Pfizer said it would stop selling Bextra at the request of United States and European regulators.
• The US Food and Drug Administration also asked the company to add a so-called "black box" warning to the label of its painkiller Celebrex, stating health risks from the drug.
• FDA officials said they asked Pfizer to stop selling Bextra, a Cox-2 pain medicine similar to Celebrex and Merck & Company's withdrawn Vioxx, because of cardiovascular risks and the possibility of a sometimes fatal skin reaction.
• Public Citizen's Health Research Group Director Dr Sidney Wolfe said, while he welcomed Bextra's suspension, the heart risks for Celebrex also warranted its removal.
• "The black box warning will lead people to think Celebrex is no more dangerous" than other pain drugs, including naproxen, Wolfe said.
• "The FDA is ultimately doing more harm than good."
• FDA veteran scientist David Graham, who called for the removal of Bextra along with four other drugs last year, said he was disappointed that the FDA did not ban high doses of Celebrex.
• Graham added the agency "took far too long" to act.
• Pfizer has vigorously defended the safety of Celebrex in the past and said on Thursday that it would work with the FDA on the new label.
• Worries about the safety of painkillers have grown since September when Merck pulled Vioxx off the market after a study showed an increased risk of heart attack and stroke.
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