The Food and Drug Administration ordered a halt to sale of the narcotic Palladone, citing potentially fatal reactions when the potent prescription drug is taken together with alcohol.
The FDA approved Palladone just last September. It is a once-a-day version of the old painkiller hydromorphone, made in a way that allows the capsules to dissolve slowly over a 24-hour period.
But data from a new study by the drug's manufacturer shows that taking Palladone together with alcohol can harm the capsule's slow-release function, rapidly dumping the narcotic into the bloodstream and potentially causing a fatal overdose, the FDA said Wednesday.
Maker Purdue Pharma agreed to suspend U.S. sales of Palladone pending further discussions with the FDA about the risk, the agency said.
Like many narcotics, Palladone's label already warns against alcohol consumption while using the painkiller.
"But the current formulation of Palladone presents an unacceptably high level of patient risk," said FDA drug chief Dr. Steven Galson. "Even one drink could have fatal implications."
The FDA said it has no reports of serious reactions among users yet, but the drug is too new to have been prescribed very often.
About 11,500 patients have taken Palladone, said Purdue Pharma spokesman Jim Heins.
The company asked drugstores and wholesalers to return unsold capsules.
Patients aren't being told to stop taking current supplies, but in a public health alert issued Wednesday, FDA urged them to consult a physician for alternative treatments. Anyone continuing to use up their Palladone supply should not drink any alcohol _ or take other prescription or over-the-counter medicines that contain alcohol.
FDA's reaction was unusually quick, coming just five months after sales of Palladone began and before the problem had come to public attention. But it comes at a time when federal regulators are being urged to more aggressively ensure the safety of drugs already on the market, pressure that has increased since Merck & Co. yanked its pain reliever Vioxx from the market last year because of potentially deadly heart trouble.
Purdue Pharma also makes the controversial long-acting painkiller Oxycontin, and it had waged a long battle to market Palladone because of concern that long-acting hydromorphone, too, might be abused. Consequently, the company had limited initial Palladone sales to doctors experienced in prescribing opioid painkillers. The drug is for moderate to severe pain, caused by cancer or other conditions, in patients who need round-the-clock relief.
Oxycontin tablets are made in an entirely different way than Palladone capsules, which package together individual controlled-release pellets of hydromorphone.