Ketek liver damage risk will lead to restrictions by FDA
According to an FDA advisory committee, the dangers of Ketek liver damage outweigh the potential benefits of the antibiotic when used to treat certain conditions. The committee has recommended that the manufacturer no longer be permitted to market the antibiotic for treatment of sinusitis or bronchitis, and that a stronger warning be required by the FDA.
The FDA committee met last week to review the risks associated with the antibiotic and considered whether a Ketek recall was necessary to protect the public. Although it was determined that the risk of Ketek liver damage outweighs the benefits provided by the drug for treatment of sinusitis and bronchitis, the committee found that it should still be approved for treatment of pneumonia, a more serious condition. Therefore, the committee has not recommended that the antibiotic be removed from the market.
>>MORE INFORMATION: Ketek liver damage side effects
The manufacturer of Ketek will likely be required to do more to warn the public of the risks of liver damage associated with the antibiotic. Most members of the FDA committee felt that Ketek dangers were serious enough to require a “black box” warning. This would be the most serious warning which the FDA could require.
Ketek lawsuits are being pursued against Sanofi-Aventis for failing to warn users of the liver dangers. Although they were aware of the serious Keteck side effects, they failed to provide sufficient warning to users which would allow them to determine whether the risks are acceptable for treatment of their illness. Many believe that the pharmaceutical company has resisted placing a full warning on their antibiotic out of fear that it would reduce their sales, which exceeded 3.3 million prescriptions in the United States last year.
The proposed restrictions on Ketek follow months of controversy surrounding approval of the antibiotic. Many have called for a Ketek recall after fraud and other problems were discovered in the studies used by the manufacturer to gain FDA approval. Keteck side effects increase the risk of liver damage, which could lead to death for some users. Symptoms of Ketek liver damage could include fatigue, malaise, anorexia, jaundice and nausea. If any of these symptoms are noted after use of the antibiotic, a liver function test should be obtained.
>>PRIOR NEWS 11/14/2006: Ketek recall to be reviewed by FDA
If you, a friend or family member have suffered Ketek liver damage, you may be eligible to pursue a lawsuit claim. To determine if you are entitled to compensation for your injuries, request a free claim evaluation.
