Ketek News
FDA criticizes company?s handling of Ketek side effects study
The Food and Drug Administration has criticized drugmaker Sanofi-Aventis for ignoring several cases of misconduct among doctors testing its antibiotic Ketek. The criticisms were sent to Sanofi in a letter faulting the company for its handling of a 1,800 pages study of Ketek side effects.
Agency calls for restrictions on Ketek use in Europe
The European Medicines Agency (EMA) has recommended that doctors avoid prescribing the antibiotic Ketek for three of its four approved uses because of the risk of Ketek side effects. The agency says that Ketek should only be prescribed to patients with bronchitis, sinusitis and tonsillitis/pharyngitis for infections caused by drug-resistant strains of bacteria. It also warned that Ketek could lead to myasthenia gravis, a condition which causes severe muscle weakness, loss of consciousness or vision problems.
Aventis knew of fraud in Ketek study, researcher says
A researcher involved in a study of the antibiotic Ketek has testified that both her former employer, Pharmaceutical Products Development (PPD), and Aventis, the manufacturer of the drug, were aware of fraudulent data in the study. Ann Marie Cisneros’ testimony before a congressional investigation into the Food and Drug Administration’s handling of Ketek comes just one day after the agency issued a “black-box” warning restricting use of the drug to serious cases of pneumonia.
FDA issues new ‘black-box’ Ketek warning
The Food and Drug Administration has issued a "black-box" warning—its strongest kind—for the antibiotic Ketek. The agency says that the drug should only be used to treat pneumonia and not less serious illnesses because of the risk of Ketek side effects. A previous warning by the FDA linked Ketek with 14 reports of liver failure in patients who were given the drug.
Replidyne halts drug trial because of Ketek dangers
A drug company has announced that it will halt clinical trials for a new antibiotic designed to treat one type of bronchitis. But unlike most cases when a clinical trial is stopped, Replidyne Inc. says that its decision isn’t because of safety concerns about the drug being tested. Instead, the company says, it decided to halt tests of its new antibiotic faropenem because of the dangers associated with Ketek, with which it was being compared in the study.
FDA panel suggests: No Ketek for bronchitis, sinusitis
A Food and Drug Administration panel has advised that the antibiotic Ketek not be used to treat acute bronchitis or sinusitis. It did, however, vote to allow Ketek to continue to be prescribed for community-acquired pneumonia, a more serious medical condition.
FDA: Ketek can stay on the market
A Food and Drug Administration advisory panel has stopped short of recalling Sanofi Aventis’ controversial antibiotic Ketek. It did, however, set limits on the use of the drug, which has been on the market for two years. Ketek has been linked with liver failure in 12 patients, four of whom died.
Beginning of the end for Ketek?
Next week, the Food and Drug Administration will convene a panel of experts to assess the reports of Ketek’s adverse drug reactions and do a risk/benefit analysis. Ketek, which is made by Sanofi-Aventis, is often used to treat respiratory infections, bronchitis, sinusitis and pneumonia. After being turned down by the FDA twice, it was approved in 2004. Still, there were enough reports of serious Ketek side effects that a bolded warning was placed on its label in June 2006 to warn doctors and patients about the possibility of liver damage or failure.
FDA, Grassley in standoff over Ketek
Dr. Andrew von Eschenbach is refusing to cooperate with a Congressional committee investigating the Food and Drug Administration’s handling of Ketek, a controversial antibiotic. Ketek, manufactured by Paris-based Sanofi-Aventis and prescribed mostly for respiratory infections, is under review due to reports of more than 100 patients who suffered adverse renal events while taking the drug. Ketek has been blamed for 12 documented cases of acute liver failure—and four deaths.
Graham critiques FDA?s approval of Ketek
Dr. David Graham of the U.S. Food and Drug Administration has questioned the continued use of the antibiotic drug Ketek, saying the agency used overseas data to blunt safety concerns raised by outside experts.