The Food and Drug Administration has declared that the Sanofi-Aventis antibiotic drug Ketek can no longer be marketed as treatment for two common ailments. It also said the drug will be required to contain on its label an extremely stern warning.
According to the FDA, Ketek should not be used to treat sinusitis or bronchitis, and it will bear on its label a black-box warning – the strongest kind – stating that it can cause liver damage or liver failure. It will also need to bear a warning that it poses a serious risk to patients who have myasthenia gravis, which is a neuromuscular disease.
Too Dangerous for Bronchitis and Sinusitis
An FDA advisory panel determined that the risks associated with the use of Ketek to treat sinusitis and bronchitis far outweighed the benefits. The panel did say, however, that the drug remained a treatment option for those with community-acquired pneumonia, which is more serious.
A hearing regarding Sanofi-Aventis and Ketek is scheduled, and witnesses are set to testify about what Aventis (the predecessor to Sanofi-Aventis) knew about the risks the drug posed, and also about the data integrity issues in the safety study on which the FDA based its approval of the drug.
The Investigations
FDA investigators have found evidence of fraud at the study site where the most patients were enrolled in the study the results of which would eventually be submitted to the FDA for the drug’s approval. The FDA approved the drug, but then later said the entire study was unreliable.
But the manufacturer isn’t the only one under investigation. The Senate is investigating how the FDA handled the drug’s approval.
“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 Charles Grassley (R-Iowa).
“It appears that a healthy dose of congressional oversight has reminded … [the FDA] to do their job and ensure the safety of drugs on the market,” said representative Edward Markey (D-Mass).
