On January 20, 2006, Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). The Food and Drug Administration ordered Sanofi-Aventis SA, the manufacturers of Ketek, to include a "black box" warning detailing potentially life-threatening liver problems on the packaging of its popular antibiotic Ketek. An FDA black box warning is the sternest advisory the organization can place on a medication. It warns that even proper use of the drug can lead to serious negative health consequences.
This warning is intended to ensure that Ketek is used only to treat pneumonia and not the less serious illnesses it had previously been prescribed for, such as bronchitis and sinusitis. The FDA determined that the potential harm caused by Ketek far outweighs the benefits gained from using it to remedy these conditions. In addition, the FDA black box warning also states that Ketek should never be used to treat myasthenia gravis, a disease that can potentially cause fatal muscle weakness. The label also includes warnings of cases of people that have lost consciousness or suffered vision problems while on the drug.
The problems with Ketek began when patients became ill with severe and potentially fatal liver ailments. The case review by Annals of Internal Medicine reports three serious adverse events following administration of Ketek (telithromycin). All three patients developed jaundice and abnormal liver function. One patient recovered, one required a transplant, and one died. When the livers of the latter two patients were examined in the laboratory, they showed massive tissue death. All three patients had previously been healthy and were not using other prescription drugs.
Ketek is already well known to cause liver damage and failure. A review released by the FDA in December 2006 listed 13 cases of liver failure caused by Ketek liver damage. A 14th case was added after the completion of the study, even though Sanofi-Aventis still maintains Ketek is a safe for use in some cases.
An estimated 5.6 million people have taken Ketek since it was approved by the FDA in 2004. Government officicals are questioning the way the FDA approved the drug and what damage it may have caused the millions of people who have taken it. Medical experts and healthcare professionals have made repeated efforts to get the FDA to take stronger steps about the labeling of Ketek in order to prevent unnecessary damage to unsuspecting patients.
In order to protect the health of the general public, the FDA advises people taking Ketek to be aware of the potentially dangerous side effects and to take these precautions:
- Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare provider immediately.
- People taking standard or generic versions of Ketek should be advised to be aware of the signs of liver damage. Conditions such as yellowed skin and eyes (jaundice) should be reported to a doctor immediately.
- Ketek should not be used to treat viral infections.
The Food and Drug Administration has had hundreds of reports of liver problems. According to their statistics, the rate of liver failure associated with Ketek use is almost four times as high as with other antibiotics. An FDA safety review concluded that there have been 35 Adverse Event Reports of liver damage caused by Ketek, including 12 instances of liver failure, four fatalities, and 23 serious liver injuries.
If you or someone you love has suffered from taking Ketek, you need to contact an attorney immediately. You may be entitled to take legal action against those that have caused your pain and suffering, but you need to act quickly. The statute of limitations in your state limits the amount of time you have to pursue your case, so if you hesitate you could lose your opportunity for financial restitution and compensation.
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