Methadone HCl 40 mg Tablets Voluntarily Restricted to Narcotic Treatment Programs and HospitalsDecember 26, 2007
The Drug Enforcement Administration (“DEA”) recently issued an advisory announcing that as of January 1, 2008, manufacturers of methadone HCl 40 mg tablets have voluntarily agreed to limit distribution due to the reported increase of adverse events related to methadone. This raises new issues for downstream distribution and prescribing of methadone.
The advisory states that manufacturers will instruct wholesale distributors to supply methadone 40 mg tablets only to authorized and DEA-registered opioid addiction detoxification and maintenance facilities and hospitals. Retail pharmacies and other registrants (including practitioners) will be unable to purchase methadone 40 mg tablets for dispensing or administration. The advisory states that methadone, a long-lasting opioid and a federally-controlled Schedule II substance, is used for pain management and opioid addiction treatment. However, DEA’s statement asserts that methadone 40 mg tablets are indicated for detoxification and maintenance treatment of opioid addiction only and not pain management.
The voluntary restriction follows an FDA public advisory and Substance Abuse and Mental Health Services Administration (“SAMHSA”) Center for Substance Abuse Treatment (“CSAT”) report. FDA issued an advisory in November 2006 warning about death and serious side effects associated with the use of methadone for pain management. SAMHSA CSAT convened a multidisciplinary meeting on methadone-associated mortality in 2003, which concluded, in part, the correlation between increased methadone distribution through pharmacies with a rise in methadone-associated mortality.