EMEA Public Statement on the Recommendation to Suspend the Marketing Authorisation for Orlaam (Levacetylmethadol) in the European Union

The document is a public statement from the European Agency for the Evaluation of Medicinal Products (EMEA) advising prescribers not to introduce any new patients to Orlaam therapy following 10 cases of life-threatening cardiac disorders in December 2000. The document includes: a brief background on the EMEA's decision making process; advice to physicians currently treating patients with Orlaam; and a warning to patients being treated with Orlaam to contact their physician immediately and not to stop taking Orlaam without medical advice.