Country

Effective Date

Description of action taken
Grounds for decision

France

October 1999

The Agency Française de Sécurité Sanitaire des Produits de Santé (AFSSPS) has suspended the marketing authorizations for medicinal products containing the anorectic agents amfepramone, clobenzorex, dexfenfluramine, fenfluramine, fenproporex and mefenorex because of their implication in the occurrence of arterial pulmonary hypertension. (Reference: La Revue Prescrire Vol. 19, No.199, October 1999.)

Oman

April 2000

The Directorate General of Pharmaceutical Affairs & Drug Control has banned the registration and import of the following anorectic agents: Clobenzorex, mefenorex, phedimetrazine, fenproporex, nor pseudoehedrine, febutazate and propylhexedrine. This action was taken because of lack of therapeutic efficacy leading to an unfavourable benefit/risk balance. (Reference Circular No. 26/2000 Directorate General of Pharmaceutical Affairs, Ministry of Health, Sultanate of Oman, 26 April 2000.)

Portugal

September 1999

The Portuguese Medicines Evaluation Committee has recommended to the Board of INFARMED the suspension of marketing authorizations for all medicinal products containing clobenzorex and fenproporex. This recommendation follows the final opinions of the Committee on Proprietary Medicinal Products that recommends the withdrawal of the marketing authorizatons for medicinal products containing amfepramone, phentermine, clobenzorex, fenproporex, mefenorex, norpseudoephedrine and phendimetrazine based on the lack of therapeutic efficacy of these products leading to an unfavourable benefit/risk balance and the withdrawal of the marketing authorizations for fenfluramine and dexfenfluramine containing medicinal products, based on an unacceptable safety profile under normal conditions of use and limited therapeutic efficacy, leading to an unfavourable benefit/risk balance. (Reference: Communication from the Instituto Nacional da Farmacia e do Medicamento (INFARMED), Lisbon, 14 September 1999.)