Palladone, which is extended-release hydromorphone, has been pulled off the market, due to "new data". Shouldn't this have been addressed before the drug was introduced just 5 months ago?

According to the FDA news release, "Palladone is a once-a-day pain management drug containing a very potent narcotic. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol the extended release mechanism is harmed which can lead to dose-dumping."

Dose-dumping, the FDA says, is the rapid release of the drug's active ingredient into the bloodstream. The agency's news release says dose-dumping, even with a low dose of Palladone (12 milligrams), could lead to "serious, or even fatal, adverse events in some patients."

The FDA warns that the risk increases for higher doses of Palladone.

Symptoms of a hydromorphone overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness, confusion, coma, tiredness, cold and clammy hands, and small pupils.

The FDA says Purdue Pharma has greed to suspend the sale of Palladone in the U.S. until the company discusses safety issues with the agency.

(Hitti, "Palladone Pain Drug Pulled Off the Market", WebMD, Jul.14)