Purdue Pharma has pulled its painkiller Palladone from the market at the FDA's request after the agency gathered evidence that the narcotic could be fatal to patients who combined it with alcohol. Palladone was introduced only six months ago with high hopes that its unique 24-hour release feature would make it a profitable product. No reports of fatalities had been received, but the FDA took action after receiving a company study that raised concerns about potential fatalities. The company says it gave the study to the FDA last November and began marketing the drug in February. The FDA says it didn't receive the last of the study data until after November.
"All powerful pain-management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk," said Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research. "Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications."
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