Risky Ketek Trials on Children
Weitz and Luxenberg is no longer accepting Ketek cases.
Chuck Grassley, a senator from Iowa, asked the Food and Drug Administration to explain what it is doing to inform parents about the safety concerns surrounding trials on children for the Ketek antibiotic.
In a letter to the acting commissioner, Grassley wrote, "The adverse events identified with Ketek are serious ones and the possibility that any six-month old child is being exposed to these kinds of risks unnecessarily is unconscionable."
The letter went on to say, "a recent internal review of safety reports by ODS officials found 110 cases of liver problems (liver failure and serious liver injury) associated with telithromycin ("Ketek"), since the antibiotic was approved in April 2004. It is alarming that most of these serious events occurred in otherwise healthy people. Based on their review, these officials recommended that the FDA 'consider forcing Sanofi-Aventis [the manufacturer of Ketek] to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects.'"
A search of the ClinicalTrials.gov website shows that Sanofi-Aventis, the company producing Ketek, has three ongoing trials in children as young as 6 months old, "TELI COM - Telithromycin in Children With Otitis Media," "TELI TON - Telithromycin in Tonsillitis," and "Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections," and a fourth trial involving adolescents 13 years of age and older, "TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults."
If you or a loved one have been affected by the drug Ketek, seek help now. Filling out the form below can get you a free case evaluation from the experienced lawyers at Weitz and Luxenberg.
see also:
Antibiotic
Learn all about the Ketek AntibioticLearn about Ketek Antibiotic and its dangerous side effects
Dosage
Recommended Dosage for KetekKnow about standard Dosage information for Ketek
Facts
Ketek- What facts you need to knowKetek and your Health: All the facts Ketek users must know
