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Contact a Miami Palladone Lawyer
Defective Drug Side Effects Topics
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The FDA stopped the sale of a potent pain drug Palladone on July 13, 2005, just five months after it made its entrance to the U.S. market. FDA approved in September 2004, and debuting that following February, the drug agency said it was concerned that “serious and potentially fatal adverse reactions can occur when Palladone extended release capsules are taken together with alcohol.”
Palladone was approved for the management of persistent, moderate to severe pain in patients requiring continuous around-the-clock opioid pain relief for an extended period of time. The FDA acquired information from a Purdue Pharma sponsored study, the makers of Palladone, that if the drug is taken together with alcohol, the extended release mechanism is harmed.
The danger of injuring the extended release mechanism is that dose-dumping can occur, meaning Palladone’s active ingredient can be rapidly released into the bloodstream. The active ingredient in Palladone is hydromorphone, which is considered a Scheduled II controlled substance, the highest level of control for drugs with a recognized medical use.
Palladone is a once-a-day pain reliever, so dose-dumping can allow dangerous overdosing to occur, which the FDA says can result in fatal consequences. Available in 12, 16, 24 and 32 milligram (mg.) capsules, the danger of dose-dumping even at the lowest marketed 12 mg. dose of Palladone could have “serious, or even fatal, adverse events in some patients,” according to the agency’s news release.
The FDA said all strong pain management drugs have serious risks if used incorrectly, but the agency’s Acting Director of the Center for Drug Evaluation and Research, Dr. Steven Galson, said “the current formulation of Palladone presents an unacceptably high level of patient risk.” An FDA spokesperson said people were receiving a full dose of Palladone all at once, and the effects could range from slow breathing to death.
Symptoms of hydromorphone overdose include slow breathing, dizziness, seizures, weakness, loss of consciousness, confusion, coma, tiredness, cold and clammy hands, and small pupils. Purdue Pharma issued a news release saying the company believed Palladone was launched “with clear and strong warnings about alcohol interaction,” which the company said was appropriately addressed in its Risk Management Program.
The FDA, however, concluded the risk of alcohol interaction could not be effectively managed by label warnings alone and a risk management plan.
The labeling for Palladone already included the standard opioid warning against the use of alcohol and Palladone, which was not stringent enough compared to the drug’s risks, according to the FDA. Due to Palladone’s short stay on the market, the FDA said only a relatively small number of people had taken the drug. Purdue said doctors had prescribed Palladone to roughly 11,500 patients, but the FDA was concerned that if more patients took Palladone, safety problems would arise.
Purdue asked the FDA to consider allowing the use of Palladone in institutional settings such as hospitals, and the company said it plans on trying to reformulate the drug.
The FDA advised all Palladone patients to consult with their physicians for alternative treatments.
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