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Europe Agency Warns on
Safety of Antibiotic in Some
LONDON (Reuters Health) - The European Medicines Evaluation Agency said on Wednesday one patient had died and others had suffered potentially life-threatening worsening of symptoms after taking Aventis' antibiotic telithromycin (Ketek). The Franco-German company warned on April 16 there had been 10 reported cases of symptoms being exacerbated among sufferers of myasthenia gravis, an autoimmune disease that causes muscle weakness, out of more than 2.7 million Ketek prescriptions worldwide. The company said at the time it was updating its prescribing information. In a statement on its Web site, the EMEA gave no figures on the number of side effects but said: "Recent reports, including one fatal case, indicate aggravation of myasthenia gravis with respiratory failure in patients treated with Ketek. "Exacerbation of muscle weakness, dyspnea (breathing difficulties) or severe respiratory failure occurred within a few hours after the first intake of drug administration." The agency said Ketek was not recommended for use in myasthenia gravis patients unless other therapies were unavailable. Patients with this condition who do take the drug should be monitored and should immediately seek medical attention if their symptoms worsen. It is still not known why some patients' symptoms worsened after taking the drug. Since Ketek's launch in Germany in October 2001, Aventis has marketed it in all the major European markets and in Latin America, and is awaiting approval in Japan, where it has teamed up with Sankyo Co. and Fujisawa Pharmaceutical Co. The drug has not yet been launched in the all-important U.S. market where investors have been concerned it could be delayed after authorities gave it only conditional clearance earlier this year. It has been touted as a potential $1-billion-a-year drug, but some industry analysts have taken a more cautious view amid stiff competition from existing drugs.
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