Ketek
Antibiotic Causes Severe Liver Damage and Death
Ketek® (pronounced KEY-tech) is a drug commonly prescribed to treat bacterial infections in the lungs and sinuses—including sinusitis, bronchitis, and pneumonia. Ketek (telithromycin) was approved by the Food and Drug Administration (FDA) in April 2004.
The FDA issued a public health advisory on January 20, 2006, after receiving three reports of severe adverse reactions in Ketek users. All three patients were jaundiced (yellowed skin) and had abnormal liver function after taking the drug. One patient recovered, one required a transplant, and one died (1).
Five months later, on June 29, 2006, the FDA reported, “The drug has been associated with rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of the drug. FDA determined that additional warnings are required and the manufacturer is revising the drug labeling to address this safety concern (2).”
Update 2/12/07:
The Food and Drug Administration announced revisions to the labeling for the antibiotic Ketek (telithromycin) that include the removal of two of the three previously approved indications—acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis—from the drug’s label.
The agency concluded the risks vs. benefits profile of treating sinusitis and bronchitis with Ketek is not worth the risk of Ketek side effects.
Additionally, the FDA mandated Ketek include a "boxed warning," the
FDA’s strongest form of warning. The warning says that Ketek should not be used
in patients with myasthenia gravis, a disease that causes muscle weakness (www.fda.gov).
The maker at the time Ketek was approved was Aventis, a French-German company that after a merger became known as Sanofi-Aventis SA (based in Paris). Sanofi-Aventis is the world’s third largest drug company with a 2005 revenue of $34 billion. The manufacturers claim Ketek is an important weapon against respiratory infections, as it prevents bacteria from growing by interfering with their protein synthesis. In 2005, Ketek was prescribed 3.35 million times in the United States and brought in $193 million. However, key members of the FDA believe that Ketek should not have been approved and poses a serious threat to patient health.
Internal Debate Regarding Ketek Dangers
On July 19, 2006,The New York Times reported that Dr. David Graham of the FDA’s drug safety office commented in an email that the approval of Ketek was a mistake. He wrote, “It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin [Ketek] is concerned.” Graham’s email message is just one of dozens provided to the newspaper that reveal a fierce debate within the FDA regarding the safety of Ketek. Dr. Graham concluded the agency should recommend the drug’s “immediate withdrawal.” The documents also reveal at least four other officials within the FDA had serious misgivings about the drug’s safety (3).
Dr. Graham said of Ketek, “We don’t really know if the drug works; no one is claiming it works better than other, safer drugs; and we’re flying blind as far as safety goes, except for our own A.D.R. data that suggests telithromycin [Ketek] is uniquely more toxic than most other drugs(3).”
Two weeks after Graham’s email message, the FDA announced changes to Ketek’s label, emphasizing that the drug could in rare circumstances cause serious liver injury, liver failure, and death.
Signs of liver damage include the following:
- Nausea
- Vomiting
- Abdominal pain
- Excessive fatigue
- Loss of appetite
- Dark urine
- Yellowing of the skin and eyes
Free Consultation
If you or someone you know has taken Ketek and suffered liver problems, call our law firm today for a free and confidential evaluation of your case. Never discontinue taking any medication without first consulting your physician.
Ketek® is a registered trademark of Aventis Pharmaceuticals, Inc.
This law firm is not affiliated with, sponsored by, or associated with the Food and Drug Administration, The New York Times, or Sanofi-Aventis.
Sources:
- FDA Public Health Advisory, accessed 07/25/06 via www.fda.gov.
- FDA Completes Safety Assessment of Ketek New Safety Information to be Added to Product Labeling, accessed 07/25/06 via www.fda.gov.
- Approval of Antibiotic Worried Safety Officials by Gardiner Harris on 07/19/06. Accessed on 07/25/06 via www.nytimes.com.
