Country |
Effective Date |
Description of action taken
Grounds for decision |
France |
1999 |
The Agence du Médicament has withdrawn the antihistamine, terfenadine from the market because the risk of ventricular arrhythmias does not justify the continuation of terfenadine on the market. (Reference: Décision de la Commission des communautés européennes du 22 September 1998.) |
Iceland |
January 1999 |
The State Committee on Pharmaceuticals in Iceland withdrew the marketing authorization for 120 mg tablets of terfenadine and 60 mg tablets were switched from OTC to POM status in January 1998 due to the occurrence of serious adverse effects. (Reference: Communication to WHO from the State Committee on Pharmaceuticals in Iceland, 17 October 2000.) |
Mauritius |
December 1998 |
The Ministry of Health and Quality of Life has withdrawn terfenadine from the market following reports of fatal drug interactions with commonly use drugs. (Reference: Letter to WHO from the Ministry of Health and Quality of Life, Port Louis, Mauritius, 27 December 2000.) |
Morocco |
February 1997 |
The National Advisory Commission for Pharmacovigilance has reviewed the overall risk-benefit of terfenadine and decided to withdraw terfenadine from the market because of the risk of cardiac arrhythmia associated with the administration of terfenadine. (Reference: Letter from the Directorate of Medicines and Pharmacy, Rabat, 24 August 1999.) |
Oman |
1997 |
The Directorate General of Pharmaceutical Affairs & Drug Control has prohibited the registration, import and sale of terfenadine due to reported serious cardiac adverse effects associated with its inappropriate use. (Reference: Pharmaceutical Newsletter 5(4): 8 (1997), Ministry of Health, Muscat.) |
Saudi Arabia |
June 1999 |
The Ministry of Health has withdrawn from the market products containing the histamine H1-receptor antagonist, terfenadine, because of reports of a potentially fatal heart condition associated with its use. (Reference: Communication from the WHO Regional Office for the Eastern Mediterranean enclosing a notification from the Ministry of Health, Saudi Arabia, 20 June 1999.) |
Singapore |
|
The National Pharmaceutical Administration in the Ministry of Health has banned terfenadine because of its association with rare but serious heart problems when taken with certain drugs, including antibiotics and antifungal drugs. (Reference: Communication to WHO, 2 August 2000.) |
USA |
1998 |
Hoechst, Marion Roussel and Baker Norton Pharmaceuticals have voluntarily discontinued distribution and marketing of all terfenadine-containing antihistamine products in the United States. Terfenadine-containing products have been associated with rare, but serious heart problems when taken with certain antibiotics and antifungals. The FDA reminded consumers and health care providers that equally safe and effective alternative drugs are available. (Reference: FDA Talk Paper www.fda.gov/bbs/topics/ANSWERS/ANS00853. html) |
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