The European Agency for the Evaluation of Medicinal Products reports that ten cases of life threatening cardiac rhythm disorders have occurred in young patients taking Orlaam (levacetylmethadol) for opiate addiction, the European Agency for the Evaluation of Medicinal Products (EMEA) reported. The agency believes the risks are serious enough to advise prescribers not to introduce any new patients to Orlaam therapy until a full risk benefit assessment has been completed by its scientific committee.

It is indicated for the substitution maintenance treatment of opiate addiction in adults previously treated with methadone. In a public statement dated December 19, the EMEA said: “ 10 cases of life threatening cardiac rhythm disorders have been reported since 1 July 1997. They include five cases of cardiac arrest associated with ventricular arrhythmias, three cases of cardiac arrhythmia and two cases of syncope.” “Finally three patients required a pacemaker insertion,” the agency added . “This raises a major concern given the fact that these life  cases occurred in young patients (median age 39/ range 23— 57)  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.”