With all the recent headlines in the news about addiction problems that have stemmed from the opiate-dependence medication “Suboxone and Subutex,” we here at The NA Blog thought it important to post original advisories on the drug that the federal government issued upon its original release for treatment to the general public. The following is an edited version of the original press release issued by FDA Talk Papers, which are created and distributed by the Press Office of the FDA. According to the website, they are for: “personnel in responding with consistency and accuracy to questions from the public on subjects of current interest,” and “are subject to change as more information becomes available.” The full version can be found at:
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01165.html

SUBUTEX AND SUBOXONE APPROVED TO TREAT OPIATE DEPENDENCE

The Food and Drug Administration (FDA) announced the approval of Subutex…and Suboxone tablets…for the treatment of opiate dependence. Subutex and Suboxone treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates….Subutex and Suboxone have been studied in over 2,000 patients and shown to be safe and effective treatments for opiate dependence….Clinical data indicate that the risk of serious diminished breathing may be less with buprenorphine than other opioids when used in high doses or in overdose situations. Nonetheless, buprenorphine has been associated with deaths due to diminished breathing, especially when used in combination with alcohol or other Central Nervous System (CNS) depressant drugs, according to reports from France where it has been available for several years.

Based on the potential for abuse of Subutex and Suboxone, FDA and its parent Department of Health and Human Services recommended that the Drug Enforcement Administration (DEA) place the active ingredient, buprenorphine, in Schedule III under the Controlled Substances Act (CSA)…Subutex and Suboxone are the first narcotic drugs available for the treatment of opiate dependence that can be prescribed in an office setting under the Drug Addiction Treatment Act (DATA) of 2000….

The sponsor, in collaboration with the FDA and with input from other Health and Human Services agencies, has developed a comprehensive risk management program designed to deter abuse and diversion from its legitimate use…The risk management program also provides for active and passive surveillance to identify if and when the drugs are being abused….Reports of the results of these surveillance efforts will enable FDA to identify untoward effects from the availability of buprenorphine and, if indicated, to take appropriate actions to protect the public health….