Less than six months after it came onto the market, the powerful narcotic painkiller Palladone was abruptly withdrawn yesterday because of evidence that the one-a-day pills could be fatal to patients who take them with alcohol.
The Food and Drug Administration asked Purdue Pharma L.P. to stop selling the drug Tuesday and the company complied yesterday, said James Heins, a Purdue spokesman.
The 24-hour extended-release medication, the first of its kind in the United States, was approved by the FDA last September for people in chronic pain who were already using morphine-based painkillers.
The agency said the withdrawal was triggered by a company study that showed potentially serious or even fatal consequences if a person abusing the drug also drank alcohol. Neither the company nor the FDA reported any instances of the problem among the 11,500 people who have been prescribed the drug.
"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," Galson said in a statement.
The label for Palladone already includes a standard warning against the use of alcohol with opioid (morphine-based) drugs. The agency said "the FDA does not believe that the risk of serious, and potentially fatal, adverse events can be effectively managed by label warnings alone and a risk management plan."
The announcement came as the federal government and some public health experts have been voicing growing concern about the abuse of prescription drugs, especially prescription narcotics such as OxyContin -- also made by Purdue Pharma.
There have been numerous prosecutions of doctors, pharmacists and pain clinic workers on charges of improperly dispensing controlled drugs to people who would abuse or sell them. The arrests and prosecutions have in turn led to growing concern among pain management specialists that patients in pain would not have access to the medications they need.
The risk cited by the FDA involved a "dosage dump -- the sudden release of the full strength of a drug designed to be absorbed slowly -- that can occur if a patient mixes Palladone and alcohol.
In its statement, Purdue said it provided the FDA with complete information about the study that identified the potential danger in November, and then went ahead with marketing the drug in February with FDA's support.
"We acted responsibly and worked closely with the FDA in launching Palladone on a limited basis with a rigorous risk-management program, and in the discussion that led to the decision to suspend marketing of the product," said Purdue President Michael Friedman. He said the company plans to reformulate the drug and reintroduce it as soon as possible.
But FDA spokeswoman Suzanne Trevino said that while the agency received some of the study data in November, "the final results were not shared until a later date."