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FDA Pulls Darvon and Companion Drug Due to Heart Risks
Date:11/20/2010

rely effective painkiller."

Dr. William O'Neill, executive dean for clinical affairs at the University of Miami Miller School of Medicine, said he had a problem with the way the FDA handled drug withdrawals, recalls and warnings.

"I'm a little annoyed, because what always happens with these drug recalls is that they tell patients to see their doctor, which puts the onus on doctors to help each individual patient make a decision about the benefit of the drug versus the potential side effects," O'Neill said.

Practicing physicians have no basis to make an informed decision, because they have not seen that data on which the FDA made its decision, O'Neill said. "I have no way of getting that information; it's not in any published journal," he said. "I have to infer from the nanny state that this is what's best -- I know what's right -- without being able to determine whether the drug is of value or not."

More information

For more on pain medications, visit the U.S. National Library of Medicine.

SOURCES: Nov. 19, 2010, teleconference with John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, and Gerald Dal Pan, M.D., M.H.S., director, Office of Surveillance and Epidemiology, both with the U.S. Food and Drug Administration; Nov. 19, 2010, news release, Public Citizen, Washington, D.C.; William O'Neill, M.D., executive dean, clinical affairs, University of Miami Miller School of Medicine


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