FDA ISSUES ADDICTION DRUG WARNING

WASHINGTON (AP) - The Food and Drug Administration is issuing a stronger
warning about a drug used to treat opiate addiction.

The agency said Friday the new warning is the result of 10 cases of serious
heartbeat rhythm changes among patients taking levomethadyl acetate HC. The
drug is used to treat addiction in patients who have had poor response to
other addiction treatments.

Levomethadyl acetate HC is manufactured by Roxane Laboratories Inc. of
Columbus, Ohio, and is marketed under the brand name Orlaam. About 33,000
patients have been treated with Orlaam since it was approved by the FDA in
1993.

The FDA said labeling for Orlaam will now include a stronger warning about
the risk of irregular heart rhythm. The warning will be highlighted with a
black box, the most prominent type of warning on prescription drugs, the
agency said.

The agency also said Orlaam is not to be used as a first line of treatment,
but reserved for patients who fail to respond to other addiction treatments.

Roxane Laboratories on Wednesday mailed letters to physicians who prescribe
the drug to alert them to the new warning.

Orlaam's effects last longer than those of methadone, another drug used to
treat addiction. Patients have to visit clinics less frequently and do not
need to take medication home with them.

The FDA said it has received "small but increasing numbers of adverse event
reports" about Orlaam, as have some European regulatory agencies.

Patients who know or suspect they have had irregular heartbeats should not
use Orlaam, the agency said, and any other drug that affects cardiac rhythm
should not be taken with Orlaam.

The agency said that adverse health effects from taking Orlaam can be
reported to 1 (800) 332-0178 or on the Internet at http://www.fda.gov/medwatch.