Sanofi-Aventis
Sanofi-Aventis is the world's number three company in the pharmaceutical industry. [1] It was formed in 2004 when Sanofi-Synthélabo merged with Aventis.
Toxic Trial
(Ed. Note: See update at end of story below.) A new antibiotic that has been found to cause four times the average rate of acute liver failure in adults continues in a trial for more than 900 children worldwide, despite criticism from a U.S. Food and Drug Administration official and a study consultant. The drug, Ketek (internationally known as Telithromycin) is manufactured by Sanofi-Aventis. The company has defended the antibiotic as safe when used as directed. [2]
"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" asks Dr. Rosemary Johann-Liang, of the FDA's Office of Drug Safety, in a memo uncovered by the New York Times. [3] Duke University infectious disease specialist Dr. Danny Benjamin echoes the concern, calling the pediatric trial "hard to support." Benjamin is especially critical of testing the antibiotic for routine ear infections at a time when antibiotics are less frequently recommended for pediatric treatment. Yet, the FDA's own website continues to promote the pediatric trial. [4] (Ed. Note: Sanofi-Aventis announced on June 8, 2006, after a flurry of negative reports, that it was voluntarily ceasing the trial of this antibiotic on children. The FDA also ceased recruitment for the study.)
Personnel
- Cressida Ward, Communications Director
Other SourceWatch Resources
Contact Details
Sanofi Aventis
174, av. de France
75013 Paris
France
Phone: (33) 1 5377 4000
Phone (Media): (33) 1 5377 4076
Fax (33) 1 5377 4174
Web: http://en.sanofi-aventis.com/
External links
- Gardiner Harris, "Halt Is Urged for Trials of Antibiotic in Children", New York Times, June 8, 2006.
- Jo Revill, "Cancer drug firm's PR trip sparks a row: MPs and charity officials defend paid-for visit to see 'gold standard' treatment at French hospital", The Observer, July 2, 2006.
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