ADVISORY ISSUED ON METHADONE

The drug could kill or seriously hurt new patients taking it for
pain, the FDA says.

Methadone, used for decades to treat heroin addicts, may lead to
death or life-threatening complications among some patients newly
taking the drug for pain, federal health officials said yesterday

The Food and Drug Administration warned doctors about the risk of
accidental overdoses or dangerous interactions with other drugs if
patients get too much methadone too often. Some have died, stopped
breathing, or had irregular heartbeats, the agency said in a notice
on its Web site.

Doctors should closely monitor people receiving methadone for the
first time, even if they have taken other strong painkillers before,
regulators said. Methadone can stay in the body more then two days,
even though its painkilling effect wears off within eight hours,
leaving some patients wanting more relief before their next scheduled dosage.

Methadone tablets, including Boehringer Ingelheim GmbH's Dolophine
and generic versions of the drug, are used to treat moderate to
severe pain or help recovering heroin addicts cope with withdrawal.
Too much methadone can cause slow, shallow breathing or changes in
the heartbeat that patients don't feel, FDA said.

The notice didn't say how many reports of deaths or serious
complications the agency received.

Closely held Boehringer, based in Ingelheim, Germany, won FDA
approval for its Roxane Laboratories unit to sell Dolophine in the
United States in 1947.

Boehringer could not immediately be reached for comment.