WEDNESDAY, Oct. 8, 2002 (HealthDayNews) -- The U.S. Food and Drug Administration has approved two new drugs for heroin addicts who are going through withdrawal. And the agency says it will allow doctors to prescribe the drugs themselves, rather than having to refer heroin users to a relatively small number of treatment clinics.
Subutex and Suboxone, manufactured by Britain's Reckitt Benckiser Pharmaceuticals, are two new formulations of the drug buprenorphine, which helps curb heroin cravings. Subutex, which contains only buprenorphine, is meant to be used at the beginning of treatment. Suboxone -- meant to maintain treatment -- contains both buprenorphine and the opiate antagonist naloxone, which is designed to guard against intravenous abuse of buprenorphine.
Both drugs come in 2 mg and 8 mg tablets that are placed under the tongue and must be allowed to dissolve. The medications were found to be safe and effective in clinical trials involving more than 2,000 people.
Side effects include cold or flu-like symptoms, headaches, sweating, insomnia, nausea and mood swings. Those symptoms usually peak at the beginning of treatment and usually last a few weeks, the FDA says.
Here is the FDA Talk Paper about the approval. And for more about heroin addiction, see the National Institute on Drug Abuse.
