Public Statement on Orlaam (Levacetylmethadol) - Life threatening Ventricular Rhythm Disorders

News 19/12/2000

The European Medicines Evaluation Agency's (EMEA) scientific committee, the Committee for Proprietary Medicinal Products (CPMP) has been made aware of 10 case reports of life-threatening cardiac disorders including ventricular rhythm disorders such as Torsades de pointes in patients treated with Orlaam (levacethylmethadol).

Orlaam1 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. Orlaam is currently marketed in the EU in Denmark, Germany, The Netherlands, Portugal, Spain and United Kingdom. This product has been made available in the USA since 1994.

These 10 cases of life-threatening cardiac rhythm disorders have been reported since 1 July 1997.

They include 5 cases of cardiac arrest associated with ventricular arrhythmias, 3 cases of cardiac arrhythmia and 2 cases of syncope. The QT interval was prolonged in 7 of the patients (from 535 msec to 800 msec) and 4 of these patients had an episode of Torsade de pointes. Finally 3 patients required a pacemaker insertion. This raises a major concern given the fact that these life-threatening cases occurred in young patients (median age is 39 years old [range: from 23 to 57 years old]), a population at low risk of developing these cardiac disorders, and given the relatively low exposure to the product.

Furthermore these cardiac disorders might have been under-recognised or under-reported.

Following a preliminary review of this new safety information, as an interim and precautionary measure while the CPMP performs a full comparative risk/benefit re-assessment of Orlaam, the EMEA wishes to draw attention to the following:

  • PRESCRIBERS ARE ADVISED NOT TO INTRODUCE ANY NEW PATIENTS TO ORLAAM THERAPY.
  • Patients currently taking Orlaam should contact their doctor for advice regarding their treatment, they must not stop Orlaam suddenly without seeking medical advice.

The attention of prescribers is drawn to the special warnings and precautions for use concerning the assessment of the risk of Torsade de pointes. The complete product information for Orlaam, (Summary of Product Characteristics and Package Leaflet) is annexed to this Public Statement.

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