Monday, October 15, 2007

Ketek Side Effects

Ketek, a drug manufactured by Sanofi-Aventis, was approved by the Food and Drug Administration (FDA) to hit the market in 2004 for the treatment of bacterial infections, ranging from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia.

However, researchers reported in January 20, 2006, three cases of severe liver problems here in North Carolina, including one death. The Law Offices of J. Neal Rodgers, is currently helping the family of the first reported death here in North Carolina involving a young Hispanic male. It is this death that sparked the interest of doctors around the country to the dangers of Ketek, also known as telithromycin. As a result of the patient's reaction to the drug Dr. John Hanson and Dr. Kimberly Clay of Carolinas Medical Center (CMC) reported to the Annals of Internal Medicine what had occurred to their patient. They urged the FDA to warn other doctors to monitor their patients who were taking Ketek.

They reported that the deceased was a healthy, 26-year-old Hispanic man who was admitted to CMC after an 8-day history of jaundice, fever, melena, and hematemesis. Two weeks before admission, the patient had computed tomography of the sinuses that showed an enhanced lesion in the nasal cavity and nasopharynx on the left, possibly a neoplasm. The patient had been taking Ketek for a runny nose and cough and completed a course of telithromycin, 400 mg, 2 tablets once daily for 5 days. Prior to this he had reported no long-term use of nonsteroidal anti-inflammatory drugs and no history of hepatitis, intravenous drug use, tattoos, or herbal medication. He died on the third day after admission to the hospital. An autopsy was performed which showed hepatomegaly and massive hepatic necrosis with an inflammatory response characteristic of hypersensitivity reaction. Examination of the liver showed massive tissue death.

After observing what had happened to this young Hispanic male, Dr. Hanson, who works in the liver transplant center at Carolinas Medical Center, said that the severity of this case, and other cases that soon came to light, warranted alerting doctors to a possible link between liver damage and Ketek.

Action taken by the Food and Drug Administration (FDA)

As of May 19, 2006 the FDA has been able to connect 12 cases of liver failure, which include four deaths due to the antibiotic Ketek. Based upon these findings, the manufacturer of Ketek added a warning label (at the insistence of the FDA) to the drug cautioning about liver injury and death.

It is important to note that members of the U.S. government had previously criticized the FDA's approval of Ketek, also known as telithromycin, due to accusations of flawed information from one of the manufacturer's tests. Ketek was refused approval by the FDA back in 2001 and 2003 due to the lack of safety information on the drug's label.

Signs and Symptoms of Liver Damage

If you are taking, or have taken Ketek, you should be aware of the signs and symptoms of liver damage which may occur during or immediately following treatment. These must be reported to a doctor immediately as some cases may be fatal. Signs and symptoms include:

  • drowsiness/ dizziness,
  • yellowing of the eyes and skin,
  • abdominal pain,
  • fever and flu like symptoms,
  • nausea,
  • dark urine or clay colored stools,
  • fatigue,
  • loss of appetite.