FDA Ketek Warnings
Ketek was approved for sale in April 2004. It is used to treat adults 18 years and older who have contracted bacterial infections such as strep throat, pneumonia, sinus infections and respiratory infections.
However, some users have experienced bad reactions to the drug. Some patients developed fatal cases of myasthenia gravis (extreme muscle weakness), jaundice, liver disease and deadly liver failure.
“Both patients taking Ketek and their doctors [should] be on the alert for signs and symptoms of liver problems.” –Dr. Steven Glason of the FDA
On the alert
The FDA required the maker of
Ketek to place additional warnings on the label. In June 2006, the FDA advised “both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems.”
Ketek, the FDA and death
On January 20, 2006, the FDA confirmed information regarding three cases of liver toxicity related to use of Ketek. As soon as it released this information, it began conducting research regarding Ketek.
Just six months later, the FDA released its reports and findings regarding Ketek. It determined that additional warnings should be made to further advise consumers of the risks associated with the drug. Changes made to the label of Ketek include warnings for patients who have the muscular condition myasthenia gravis.
Ketek use has been associated with the fatal worsening of this neuromuscular condition. More warnings were added concerning other serious Ketek side effects, including its link to liver failure.
Patients who have taken Ketek may experience yellowing of the skin and eyes, commonly known as jaundice. Jaundice is a serious sign of liver toxicity, which can ultimately lead to liver failure and death.
