FDA Public Health Advisory

Methadone Use for Pain Control May Result in Death and Life-Threatening Changes in Breathing and Heart Beat

On November 27, 2006, the Food and Drug Administration (FDA) issued a Health Advisory announcing that it had revised the package insert for methadone. OTPs are encouraged to download and read the SAMHSA/CSAT “Dear Colleague” letter (PDF, 89 KB) below explaining the Dolophine tablet label changes and contrasting these with the use of methadone in opioid treatment settings.

Additionally, OTPs are encouraged to visit the FDA Health Advisory Web site at http://www.fda.gov/cder/drug/advisory/methadone.htm and package insert at http://www.fda.gov/cder/foi/label/2006/006134s028lbl.pdf.

For more information, contact the SAMHSA OTP Extranet Information Center at 1-866- OTP-CSAT (1-866-687-2728) M-F, 8:30 a.m. - 5 p.m. EST.

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link to the Substance Abuse & Mental Health Services Administration