The US Food and Drug Administration is requiring a stronger warning onlabeling for Roxane Laboratories' Orlaam (levomethadyl acetate HC), a drug used to treat opiate addiction, after receiving notification of 10 cases of serious heart rhythm disturbances among patients taking the drug. The agency noted that about 33,000 patients have been treated with Orlaam since it was approved in 1993.
Labeling for Orlaam, which is indicated for the second-line treatment of opiate dependence after the failure of first-line drugs such as methadone, will now include a "black box" warning about the risk of irregular cardiac rhythm. Roxane has sent out "Dear Doctor" letters to alert physicians to the new label. Patients who suspect they have had irregular heartbeats should not use the drug, the agency said, and any other product that affects cardiac rhythm should not be taken with Orlaam.
The FDA added that it has received a "small but increasing number of adverse event reports" about Orlaam, as have some European regulatory agencies.
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