In July 2005, the U.S. Food and Drug Administration asked drug maker Purdue Pharma to withdraw its powerful narcotic painkiller Palladone from the market because of serious and potentially fatal adverse reactions that can occur when extended release capsules are taken together with alcohol. Palladone, also known as hydromorphone hydrochloride, is indicated 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.
According to a new company study, alcohol may harm Palladone's extended release mechanism, causing rapid delivery of the drug's powerful active ingredient into the blood stream. The quick release could lead to serious, or even fatal, adverse events in some patients and the risk is even greater for higher strengths of the product. Physicians have prescribed Palladone to nearly 12,000 patients since its approval in September 2004.
The current labeling for Palladone already includes a warning against the use of alcohol and the painkiller. However, 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."
See Also
- Painkillers: Overview