USA. The FDA has advised Purdue Pharma to suspend the sales and marketing of hydromorphone hydrochloride (Palladone) controlled-release capsules in the US, as co-ingestion of the drug with alcohol may cause severe adverse effects, such as depressed breathing, coma and even death. The FDA is not aware of any reports of life-threatening adverse effects in patients drinking alcohol while receiving hydromorphone, which has been for sale in the US since January 2005. However, the results of a recent company-sponsored pharmacokinetic (PK) study show that the co-ingestion of alcohol affects hydromorphone hydrochloride's controlled-release mechanism, which may lead to the rapid release of hydromorphone and result in high peak plasma hydromorphone concentrations; during the co-ingestion of hydromorphone and 4% alcohol, some subjects developed almost twice the peak plasma hydromorphone concentration observed with the ingestion of hydromorphone hydrochloride and water. Based on available data, the agency has concluded that the overall hydromorphone hydrochloride (Palladone) risk/benefit profile is unfavourable because of this potentially fatal interaction.

The FDA advises health-care providers, who have prescribed hydromorphone hydrochloride, to contact patients who are affected, to advise them not to use hydromorphone with concomitant alcohol, and to prescribe an appropriate substitute. Patients receiving hydromorphone hydrochloride (Palladone) are advised to contact their physician to discuss alternative treatment, including immediate-release hydromorphone, and to avoid alcohol, or medicines containing alcohol, on the days that they take hydromorphone. The FDA recommends that unused hydromorphone hydrochloride (Palladone)-capsules should be flushed down the toilet for safe disposal.

Reference:

FDA News. United States Food and Drug Administration, 13 July 2005 (http://www.fda.gov).