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.