With Palladone Pulled, FDA Looks at Other Opioids: Agency, Company Agree That Concomitant Use of Alcohol Could Cause 'Dump' of the Hydromorphone

By Ault, Alicia | Clinical Psychiatry News, September 2005 | Go to article overview

With Palladone Pulled, FDA Looks at Other Opioids: Agency, Company Agree That Concomitant Use of Alcohol Could Cause 'Dump' of the Hydromorphone


Ault, Alicia, Clinical Psychiatry News


Shortly after Purdue Pharma announced in July that it was taking its 24-hour opioid Palladone off the market because of a potentially fatal interaction with alcohol, the Food and Drug Administration said it was looking into the possibility that other sustained-release narcotics could pose the same danger.

The Palladone withdrawal (hydromorphone HCL extended release) came at the same time the FDA announced it was investigating whether the transdermal fentanyl patch marketed as Duragesic might be linked to a number of deaths.

"We are investigating 120 deaths that seemingly are related to overdose," Robert Meyer, M.D., director of the Office of Drug Evaluation II at the Center for Drug Evaluation and Research (CDER), said in a statement.

The FDA actions throw yet another category of painkillers into an uncertain light.

Stamford, Conn.-based Purdue withdrew Palladone just 5 months after it was introduced to a limited number of prescribers. The FDA and the company agreed that testing showed that concomitant use of alcohol could cause a "dosage dump" of the hydromorphone. But there's a difference of opinion on what was known when.

Purdue, which also makes the oft-diverted and abused oxycodone (OxyContin) had conducted several tests to assess Palladone's susceptibility to tampering, spokesman James Heins said in an interview. In the lab, Purdue researchers used various means to cause an instantaneous release of Palladone's contents to produce euphoria. Dissolving capsules in alcohol did just that, Mr. Heins said.

A similar effect was observed when healthy volunteers were given 8 ounces of various proofs of alcohol (all the subjects were given naltrexone as a block).

Data from these studies were given to FDA in November, several months after the drug's approval in September 2004, but before it had been formally launched, he said.

The FDA, however, said those were "preliminary" data, and that a full report was not received until February 2005. With those full data in hand, CDER officials met with Purdue again in May to discuss strengthening Palladone's warnings. But the agency decided that the risk of death from inadvertent concomitant alcohol use was significant enough that even Palladone's strict risk management plan could not prevent potentially serious adverse events or deaths, according to an FDA spokesperson.

"CDER concluded that had it been aware of the alcohol interaction prior to approval, Palladone would not have been approved," the spokesperson said in an interview.

The Purdue tests on Palladone led the agency to consider whether other sustained-release opioids might pose the same risk. …

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