Public Statement on Levacetylmethadol (Orlaam) - Life Threatening Cardiac Rhythm Disorders

News 15/12/1999

The European Commission granted a marketing authorisation for the European Union to Sipaco Internacional Lda. on 1 July 1997 for the medicinal product Orlaam, which contains the active substance levacetylmethadol. Orlaam is marketed in Austria, Denmark, Germany, Ireland, The Netherlands, Portugal and Spain.

Orlaam is indicated for the substitution maintenance treatment of opiate addiction in adults previously treated with methadone, as part of a comprehensive treatment plan including medical, social and psychological care. The European Medicines Evaluation Agency's (EMEA) scientific committee, the Committee for Proprietary Medicinal Products (CPMP) has been evaluating new safety information as it emerges.

At the time being an estimated 3500 patients in the United States and 700 within the EU are currently treated with Orlaam. Since 1 July 1997, 2 cases of torsade de pointes (a life-threatening cardiac rhythm disorder) and 1 case of sudden death associated with levacetylmethadol administration have been reported.

Following a review of the new safety information, the EMEA wishes to draw attention to the following:

  • Levacetylmethadol should not be administered in patients with known or suspected QT prolongation (corrected QT, QTc> 440 ms), e.g. congenital long QT syndrome, or conditions which may lead to QT prolongation (clinically significant bradycardia less than 50 bpm, any other clinically significant cardiac disease, concomitant treatment with Class I and III antiarrhythmics).
  • Levacetylmethadol should not be administered concomitantly with other medicinal products or medical conditions known to prolong the QT interval (see product information indicated below) or known to induce hypokalaemia or hypomagnesaemia.
  • The patients experiencing symptoms suggesting the occurrence of a severe arrhythmia (torsade de pointes) such as palpitations, dizziness, syncope or convulsion should seek urgent medical advice. Levacetylmethadol should be discontinued, and the patient should be evaluated for QT prolongation and arrhythmias.

As an urgent measure, the prescribing and patient information has been modified through a rapid procedure at the request of the marketing authorisation holder. The EMEA considers it necessary to provide this new information to the public.

Relevant changes to the product information are indicated below. For the complete scientific evaluation of Orlaam and the complete revised product information see the European Public Assessment Report, also available on the EMEA website.

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