Some say FDA should have sought Celebrex removal too

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A prominent consumer advocate and an outspoken FDA scientist welcomed the suspension of Pfizer Inc.’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 U.S. and European regulators. The U.S. 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said they asked Pfizer to stop selling Bextra, a Cox-2 pain medicine similar to Celebrex and Merck & Co. Inc.’s withdrawn Vioxx, because of cardiovascular risks and the possibility of a sometimes fatal skin reaction.

"(Bextra) has the same cardiovascular problem, no special benefit and this added, worse skin risk,” Steven Galson, acting director for FDA’s drug center, told reporters.

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. “Given that (Bextra) offered no unique advantages, why was it allowed to stay on the market as long as it was,” he said.

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.

The decision to pull Bextra comes seven weeks after a panel of outside experts narrowly recommended the three drugs were safe enough to be sold in the United States.

Agency officials usually, but not always follow the advice of their advisers. Some agency observers said it was not clear whether the FDA’s decision on Thursday signaled a tough new stance on drug safety.

“It will be good news if today’s action...is a turning point and indicates a more independent Food and Drug Administration,” said Senate Finance Committee Chairman Sen. Charles Grassley, who held a hearing in November about the FDA’s handling of drug safety concerns.

“Otherwise today’s action may raise more questions than it gives answers for patients and their doctors,” the Iowa Republican added.

The new painkiller warnings “affirm that the FDA is serious about drug safety,” said Prudential analyst Diane Duston, who follows the agency.

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.

Makers of older, pain drugs like naproxen also will add risk information to their labels, the FDA said.

“The agency is under pressure to do its job more effectively,” said Merrill Goozner, head of the Center for Science in the Public Interest’s Integrity in Science Project.

Some doctors said the FDA’s wrangling over painkiller safety left them and their patients confused.

“We’ve had people on and off medicines and people are somewhat distrustful of the FDA and the pharmaceutical industry right now,” said Dr. Stephen Lindsay, chief of rheumatology at Ochsner Clinic Foundation in Baton Rouge, Louisiana.

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