FDA Still Dodging Bullets over Ketek
October 15, 2006 08:23

In 2000, Ketek initially sought FDA approval but was denied due to potential side effects such as liver damage, blurred vision, and more discovered in Aventis clinical trials.The FDA requested more information so the drug maker hired Pharmaceutical Product... (Read Article)

Health Canada Endorsed Ketek Safety Info
October 15, 2006 08:24

Sanofi-aventis Canada Inc., in consultation with Health Canada, has important updated safety information regarding KETEK (telithromycin) tablets. The following information was obtained from reports of Ketek side effects received from health care professionals and consumers. Some patients have experienced liver problems during or following treatment with Ketek. Rare cases of severe liver injury have been reported and have resulted in death. In myasthenia gravis patients, reports have also included life-threatening breathing trouble and death. Fainting has also been reported in some patients taking Ketek.

There have been rare reports of severe liver injury, which can be life-threatening. The signs and symptoms of liver failure include fatigue, malaise, loss of appetite, nausea, yellow skin, and dark-colored urine. In patients with a neuromuscular disease known as myasthenia gravis, there have been reports of a sudden worsening of symptoms during KETEK treatment. (Pharma Live)