Ketek (telithromycin) is an FDA-approved antibiotic that is used to treat common respiratory infections including chronic bronchitis and acute bacterial sinusitis. On January 20, 2006, an article published by Annals of Internal Medicine reported patients having serious liver complications following the use of Ketek. Due to this report and as a result of an FDA investigation, new safety information has been added to the product's labeling.
Since the approval of Ketek in 2004, the FDA had received reports of serious liver problems in patients taking the drug, including some cases of acute liver failure leading to death or requiring liver transplantation. Ketek has also been linked to arrhythmia, in some cases resulting in sudden death.
Additional side effects and risks associated with Ketek are:
- Hepatitis
- Myasthenia Gravis (rare neurological/neuromuscular disorder)
- Nausea
- Stomach pain
- Low fever
- Lost appetite
- Dark urine
- Clay-colored stools
- Jaundice (yellowing of the skin or eyes)
- Blurred vision
- Loss of consciousness
Ketek, which is manufactured by Sanofi-Aventis, was originally denied FDA approval in 2001 and in 2003 due to the lack of safety information. Based on the findings from the report by Annals of Internal Medicine, the FDA began sending out the following recommendations to healthcare providers and patients that may be affected by Ketek's adverse side effects.
- Healthcare providers should monitor patients taking Ketek for signs or symptoms of liver problems. Ketek should be stopped in patients who develop signs or symptoms of liver problems.
- Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare provider immediately.
- As with all antibiotics, Ketek should only be used for infections caused by a susceptible microorganism. Ketek is not effective in treating viral infections, so a patient with a viral infection should not receive Ketek since they would be exposed to the risk of side effects without any benefit.
If you or a loved one have taken Ketek and have experienced serious liver problems, Hepatitis or Myasthenia Gravis, please call us at 1.800.966.4999 or fill out the form to the right of the page for immediate attention to your case.
