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A lawsuit was filed this week against the makers of Ketek on behalf of the widow of Otto J. Laven, a Milwaukee man who died of respiratory arrest shortly after taking the antibiotic for treatment of his bronchitis. The suit, filed in the Milwaukee County Circuit Court, alleges that Ketek (also known as “Telithromycin”) was defective and unreasonably dangerous for use by patients with a condition known as myasthenia gravis a rare neurological disorder. The suit also alleges that the manufacturer misrepresented the drug’s risks, which included liver disease, respiratory failure and death, in order to obtain approval from the FDA.

Ketek is manufactured by Sanofi-Aventis, the third largest pharmaceutical company, and was originally approved by the FDA to treat bronchitis, sinusitis and mild-to-moderate pneumonia. The circumstances under which the Ketek’s drug was approved have been mired in controversy, with FDA scientists concerned about the reliability of the manufacturer’s data and clinical studies conducted during the pre-approval stage. Fabrication of clinical data was discovered at the site of the clinical investigator who had the largest number of enrollees, Dr. Anne Kirkman Campbell, leading to that doctor’s criminal conviction for fraud.

In June, 2006, after conducting its safety evaluation, the FDA announced its conclusion that Ketek’s benefits outweigh its risks, but it determined that additional warnings were required, and advised both patients and doctors to watch for signs and symptoms associated with liver injury. By December 2006, an FDA committee was investigating reports that linked Ketek to liver failure, with 53 reported cases, including two people who needed liver transplants and five deaths.

In February, 2007, the FDA removed its approval of Ketek for treatment of bronchitis and sinusitus, having determined that the “balance of benefits and risks no longer support approval for the drug for these indications.” The FDA also required that Ketek’s instructions include a black box warning–the strongest warning available–indicating that the drug was not to be used for patients with myasthenia gravis. The only application for which the drug remains approved is for the treatment of community acquired pneumonia of mild to moderate severity.

The FDA actions limiting the use of Ketek have certainly helped many patients avoid suffering, and saved some lives, but it is too late for Otto, who died three years ago today. Hopefully, the civil justice system will provide some solace and compensation to the wife and children he has left behind.

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