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The Food and Drug Administration said Ketek, an antibiotic manufactured by drug giant Sanofi-Aventis, can no longer be marketed as treatment for two common sicknesses, and will now be required to carry a stronger warning on its label.
Ketek should only be used for the treatment of community-acquired pneumonia, researchers say.
Ketek has been found to cause liver failure, liver damage, and has also been found to pose a severe risk to patients who have myasthenia gravis, a neuromuscular disease.
Label Warning Issues
Sanofi-Aventis has been required to strengthen the warning on Ketek bottles before. In June, the FDA required it to add a warning about liver damage and failure.
This time, the label will be required to carry a black box warning, which is the strongest, most prominently displayed drug label warning. This warning will tell myasthenia patients to not use the drug.
In December, an FDA advisory committee said that the risks of Ketek outweighed its benefits for bronchitis and sinusitis, though they held that it should still be an option for those suffering community-acquired pneumonia – a more serious sickness.
Unscrupulous Business Practices?
A hearing is scheduled in which there will be testimony raising questions about what the drug's original maker, Aventis, the predecessor to Sanofi-Aventis, and its contractors knew about data integrity problems with the drug's safety study before its FDA approval in 2004.
The FDA has discovered evidence of fraud at one of the sites that handled the most patients during the study, and has since determined that the entire study is unreliable.
“The FDA's action today shows that transparency can do. When a spotlight was turned on the questionable way in which Ketek got approved by the FDA for certain sinus and lung infections, the FDA was held accountable,” said Sen. Charles Grassley, who has long been a critic of Ketek, and how the FDA has handled its approval.
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