FDA to Recommend Ketek Label Change

The FDA has recently issued an advisory to French pharmaceutical giants Sanofi-Aventis in regards to their respiratory infection drug, Ketek. The FDA issued the advisory amidst growing concern about the link between the use of Ketek and the development of potentially fatal liver damage.

The brand name for telithromycin, Ketek is the first ketolide antibiotic drug to be approved for clinical use. Ketek is used to help the body fight off infections related to certain respiratory ailments. The ketolide antibiotic drug interferes with protein synthesis of certain bacteria, preventing its growth and spread.

Ketek “Black Box” Warning

The FDA are currently working with Sanofi-Aventis officials to work out an agreeable way through which to properly warn Ketek patients about the grave health hazards that have recently been linked with use of the ketolide antibiotic. While the FDA does not yet believe the health concerns warrant a Ketek recall, it is of the opinion that labeling revisions should be implemented so as to adequately warn consumers about the risks related to liver damage.

One possible option that is being reviewed is the issuing of a “black box” warning for Ketek – a black box warning is the strongest warning that the FDA can place on a prescription drug. Ketek manufacturers refuse to concede that the antibiotic drug is unsafe for use, claiming that any link between the onset of liver damage and Ketek use is likely attributed to incorrect use of the drug.

Ketek Side Effects – Ketek Liver Damage

Sanofi-Aventis has been under fire since January of 2006 because of certain links found between the use of Ketek and the sudden onset of liver damage. According to an internal FDA memo, approximately 12 cases of liver damage resulting from Ketek use have thus far been established; four of which have resulted in patient death. The serious nature of this Ketek side effect has prompted FDA suggestion that Sanofi-Aventis amend the drug’s label so as to properly warn consumers of the risks associated with Ketek use.

In addition to the development of Ketek liver damage, the ketolide antibiotic drug has been linked with a number of other side effects, some of which include:

  • Irregular heartbeat
  • Fainting
  • Allergic reaction
  • Vision problems
  • Mild nausea
  • Headache
  • Dizziness
  • Ketek and the FDA

The problems associated with serious Ketek side effects are furthered by the controversy that surrounded FDA approval of the ketolide antibiotic drug in 2004. Ketek had been disapproved twice by the FDA prior to 2004; once in 2001 and again in 2003. The FDA claimed that both disapprovals were prompted by concerns regarding the safety of Ketek.

The FDA’s eventual approval of Ketek caused a great deal of controversy. Charges were levied in regards to reports of faulty data that was produced from one of the Ketek clinical trials, bringing into question the grounds on which the drug was approved.

Ketek Lawsuits

Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for defective drug litigation. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by drugs. Contact AWKO law today at (844) 794-7402 to get more information about your rights as a Ketek injury victim.