Research shows the antibiotic telithromycin—sold under the brand name Ketek—causes autoimmune neuromuscular disease myasthenia gravis and acute liver failure.
What Is Ketek? When Is It Prescribed?
Ketek is a brand name for the drug telithromycin. Made and sold by the French pharmaceutical company Sanofi-Aventis, this prescription medication is used to treat mild to moderate respiratory infections such as bronchitis, sinusitis, and pneumonia.
In 1998, Hoeschst Marion Roussel, one of Sanofi-Aventis’ predecessors, ran clinical trials of telithromycin. The European Commission approved the drug in 2001, and the U.S. Food and Drug Administration (FDA) approved Ketek in April 2004. Sanofi-Aventis began selling Ketek in tablet forms in 300mg and 400mg doses taken twice daily with or without food. In 2005, Ketek sales reached $264 million, 70 percent of which occurred in the United States. By 2007, doctors had written 6 million prescriptions for the drug.
Telithromycin is a ketolide antibiotic that disrupts protein synthesis inside bacteria cells. After ingestion, the liver metabolizes it. Unfortunately, the drug causes side effects that are largely gastrointestinal in nature, including diarrhea, nausea, abdominal pain, and vomiting.
Since 2006 controversies have eroded consumer confidence in Ketek. Consequently, in February 2007, the FDA placed a “black box warning,” the agency’s most serious alert, on Ketek. There are no known efforts to issue a Ketek recall or ban the drug, but dozens of harmed Ketek users have filed lawsuits against Sanofi-Aventis.
Ketek Might Cause Life-Threatening Side Effects
On February 12, 2007, the FDA reduced the number diseases for which Ketek could be prescribed from 3 to 1. Doctors could no longer prescribe the antibiotic for acute bacterial sinusitis or chronic bronchitis because the benefits the drugs provided paled when compared to the risks the drug caused, especially to users’ livers. The FDA also required Sanofi-Aventis to provide a “black box” warning on Ketek to ensure that those with the autoimmune neuromuscular disease myasthenia gravis would not take the drug. Ketek can still be prescribed for mild to moderate forms of pneumonia.
After the FDA originally approved the drug in 2004, reports of adverse affects on users’ livers began surfacing. Before the label change in 2007, the FDA confirmed Ketek caused 53 cases of acute liver failure, resulting in 5 deaths.
Ketek’s problems are not like those of a drug whose potential side effects were not understood when it was approved. Instead, the clinical trials to approve Ketek were rife with fraud and the FDA’s approval process was circumvented. Dr. David Graham of the FDA office responsible for drug safety told the New York Times, “It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned.” Of those principles, an important one requires the drug to be at least as safe as drugs currently on the market. Ketek apparently was not.
By the time the U.S. House of Representatives Committee on Energy and Commerce held hearings on Ketek, it became clear that the clinical trials for Ketek drastically misreported the drug’s effectiveness. The trials covered 24,000 users, and one doctor, Maria “Anne” Kirkman-Campbell, pled guilty to fraud against Sanofi-Aventis after she faked the trial results that should have demonstrated that telithromycin causes liver damage. Dr. Campbell is serving a 57-month prison sentence and paid large fines to the pharmaceutical company. One former employee of the research firm that Aventis (before it consolidated into Sanofi-Aventis) had contracted to conduct the Ketek clinical trials claimed that both Aventis and the research firm knew the trial results were being falsified but did nothing.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Ketek lawsuit on your behalf if necessary.
If you have taken Ketek and believe it harmed you, contact RLG today.