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T01-15 Print Media:
301-827-6242April 20, 2001 Broadcast Media:
301-827-3434Consumer Inquiries:
888-INFO-FDA - The U.S. Food and Drug Administration
(FDA) issued a new warning about - health risks associated with levomethadyl
acetate HC, a.k.a. Orlaam, a drug - used to treat opiate addiction.
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FDA Announces Labeling
Changes Following Cardiac Adverse Events With Addiction DrugThe 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 — FDAs safety
surveillance program. An estimated 33,000 patients have been treated with
Orlaam to date.Roxane Laboratories, Inc., the drugs
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 drugs
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. -
was released by The European Agency
EMEA – which is to be found at
Click on the “Product Alert” button.
their patients [receiving LAAM] immediately.
In addition, physicians are advised to switch their patients from
Orlaam to another existing alternative, e.g., methadone.”
“suspending the marketing authorizations of
immediately! If there is any way possible, have your treatment
provider change your medication to methadone until more is known about the
risks involved with using LAAM.