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FDA Announces Labeling Changes Following Cardiac Adverse Events With Addiction Drug

The FDA is strengthening warnings to physicians about serious cardiac adverse events associated with Orlaam (levomethadyl acetate HC), a drug for opiate addiction treatment.

FDA has changed the Orlaam labeling to increase the strength of the warnings and to highlight these warnings in a black box, the most prominent warning on prescription drugs.

In addition, the approved indication for Orlaam will be revised to indicate that the drug is not to be used as first line therapy. Orlaam should be reserved for use in treatment of opiate-addicted patients who fail to show an acceptable response to other adequate treatments for addiction.

As of March 30, 2001, 10 cases of serious arrhythmias have been submitted to FDA through MedWatch -- FDA’s safety surveillance program. An estimated 33,000 patients have been treated with Orlaam to date.

Roxane Laboratories, Inc., the drug’s manufacturer, mailed a Dear Healthcare Professional letter on April 18 to physicians licensed to treat narcotic addiction.

Approved in 1993, Orlaam can be given less often than methadone, which means that patients visit the clinic less frequently and do not need to bring medication home.

At the time of approval there was a signal that the drug may prolong cardiac conduction, and as a result, the labeling included precautions about cardiac adverse events. Since the drug’s approval, FDA has received small but increasing numbers of adverse event reports. In addition, European regulatory agencies have also received reports of serious cardiac arrythmias, or deviations of the normal heart rhythm.

ORLAAM is contraindicated in patients with known or suspected arrythmias and any drug known to have the potential to cause abnormal heart rhythm should not be used together with Orlaam.

If a patient taking Orlaam experiences palpitations, dizziness, light-headedness, or seizures, the patient should seek medical attention.

More information about ORLAAM and labeling changes, is available from Roxane Laboratories Technical Product Information at 1-800-962-8364. Cases of adverse events may be reported to 1-800-FDA-0178, or on the internet at www.fda.gov/medwatch.

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