Ketek Side Effects

Since its approval by the Food and Drug Administration (FDA) in 2004, Ketek, the first antibiotic of the ketolide class, has been under constant scrutiny from the FDA's Division of Drug Risk Evaluation. The FDA rejected the French-manufactured drug in 2001 and again in 2003 because of the insufficient warnings on the label.

Severe Ketek Side Effects:

- Liver injury - An analysis of previous clinical studies and reports found that Ketek is linked with almost two dozen cases of serious liver damage and injury (one of which required a liver transplant), 12 cases of liver failure that resulted in four deaths, and at least 44 cases of less serious, but potentially life-threatening liver problems.

In addition, some patients experienced liver injury within the first several days of taking Ketek and almost none had any health problems that could have contributed to liver damage. Experts are advising patients taking Ketek and their doctors to monitor for symptoms of liver damage such as jaundice, abdominal pain, dark urine, and loss of appetite.

- Severe colon inflammation - May result from an overgrowth of bacteria in the colon that can lead to serious life-threatening risks. Patients are advised to stop using Ketek and contact a healthcare professional immediately if any of the following symptoms develop: severe abdominal cramps, watery diarrhea, bloody stools, fever, or frequent bowel movements.

- Heart rhythm irregularities - Ketek may affect heart rate that could lead to serious injuries. Patients with low magnesium or potassium levels, congenital heart irregularities, or an exceptionally slow heartbeat should exercise extreme caution when using Ketek. Such conditions may make an individual more susceptible to heart rhythm irregularities.