The pharmaceutical company Sanofi-Aventis has stopped enrolling children in clinical trials of an antibiotic that some reports said could cause liver failure in adults.
July 7, 2006 (Press Release) --
The pharmaceutical company Sanofi-Aventis has stopped enrolling children in clinical trials of an antibiotic that some reports said could cause liver failure in adults.
The drug maker said it halted tests on its own Thursday to ensure that trials of the antibiotic Ketek complied with U.S. Food and Drug Administration requirements, the Associated Press reported Friday.
On Thursday, The New York Times cited internal FDA memorandums that said some safety officials believed the company should remove Ketek from the market, severely restrict its use or add a prominent warning label about its potentially fatal side effects. The company denied the suspension was linked to the newspaper's report.
Ketek is currently approved only for adults and is used to treat sinusitis, bronchitis and pneumonia. The company had been testing the drug as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries, including the United States.
Source: http://www.msn.com/
The drug maker said it halted tests on its own Thursday to ensure that trials of the antibiotic Ketek complied with U.S. Food and Drug Administration requirements, the Associated Press reported Friday.
On Thursday, The New York Times cited internal FDA memorandums that said some safety officials believed the company should remove Ketek from the market, severely restrict its use or add a prominent warning label about its potentially fatal side effects. The company denied the suspension was linked to the newspaper's report.
Ketek is currently approved only for adults and is used to treat sinusitis, bronchitis and pneumonia. The company had been testing the drug as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries, including the United States.
Source: http://www.msn.com/
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