FDA asked to stop deadly antibiotic trials in children

Sigh.

http://www.foodconsumer.org/777/8/FDA_asked_to_stop_deadly_antibiotic_trials_...
FDA asked to stop deadly Antibiotic trials in children
By Catherine Snipe
Jun 23, 2006, 15:58

June 23, (foodconsumer.org) - Amid four patients' deaths from liver failure, the Antibiotic drug Ketek and its approval by the Food and Drug Administration are being challenged this month by three U.S. Congressmen and independent health experts.

On June 8, the New York Times reported an FDA official is also concerned about clinical trials of Ketek, which is used to treat mild to moderate respiratory infections in adults.

According to the news outlet, a Food and Drug Administration official called for the drug manufacturer to cease its trials of the Antibiotic in children. Internal memoranda sent to other FDA officials said the drug could be deadly, according to the report.

Ketek (Telithromycin) is dispensed as a 400 mg tablet available by prescription. Sanofi-Aventis Pharmaceuticals, the antibiotic maker gained FDA approval in 2004. Telithromycin is the first ketolide antibiotic to enter clinical use, but it is approved for adults.

The reported side effects of its adult use include liver failure, unconsciousness and blurred vision.
According to the New York Times, Ketek was being tested on nearly 4,000 children, as a treatment for ear infections and tonsillitis.

An FDA memo obtained by the New York Times questions whether the side effects outweighed the usefulness against respiratory infections.

"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" wrote Dr. Rosemary Johann-Liang, an official in the Office of Drug Safety at the agency, in one of the memorandums, quoted by the new outlet, who obtained a copy of the memorandums.

In response to criticism that the FDA approval process for Ketek was flawed and by some accounts fraudulent, spokespersons for Aventis and the FDA said they were involved in ongoing discussions regarding Ketek.

Two U.S. Congressmen are calling the antibiotic into question, as Representatives Henry Waxman and Edward Markey seek information from the FDA on the integrity of clinical trials of Ketek on children as young as seven-months old.

"Although the FDA has consistently assured the public of Ketek's safety and efficacy, public documents obtained and examined by our staff indicate that the approval process for the drug is seriously flawed," the pair wrote to the FDA commissioner in May.

They say the public has a right to know how the FDA reached its decision to approve Ketek and if they can rely on those conclusions.

A senator is wondering the same thing. Senate Finance Committee Chairman Charles Grassley said he believes the FDA is not forthcoming about its review of Ketek and the link to liver damage, Reuters reported June 14.

"I smell a cover-up," said the Iowa Congressman, a republican, to Reuters. Grassley has launched a probe of a study of the drug, and said the FDA failed to make available one of its criminal investigators for questions. He may hold a congressional hearing on the FDA's approval of Ketek and subsequent monitoring of its safety.

According to media reports, an internal review of reports by Office of Drug Safety officials found more than a hundred cases of liver failure or serious liver injury associated with Ketek after the drug's approval. That includes 12 adults who suffered liver failure, which killed four patients.

"Sanofi-Aventis continues to believe that the benefits of Ketek outweigh any known risks of this drug when used for FDA-approved indications," spokeswoman Melissa Feltmann said, quoted by the Los Angeles Times.

The FDA said it was cooperating with Grassley's investigation, according to Reuters.

In January, the FDA released a public health advisory regarding Ketek, suggesting healthcare providers should monitor patients taking telithromycin for signs or symptoms of liver problems. Patients who develop signs or symptom of liver problems should stop taking telithromycin, according to the FDA.