Antibiotic Receives Low Grade From Federal Panel, Which Urges Limits and Warnings
New York Times - Saturday, December 16th
The risks of the controversial antibiotic Ketek outweigh its benefits for minor illnesses and it should not be sold to patients with sinusitis or bronchitis, a federal advisory panel concluded yesterday...

FDA subjects antibiotic to new scrutiny
BusinessWeek - Tuesday, November 14th
The Food and Drug Administration has asked a joint panel of outside experts to discuss the overall risks and benefits of the antibiotic Ketek during a December panel ...

FDA Still Dodging Bullets Over Ketek
Media Monitors Network - Wednesday, October 4th, 2006
The debacle involving the FDA approval of Ketek has now become a bi-partisan battle against senior FDA officials by members of Congress from both sides of the isle."

Users warned about Ketek
London Free Press - Canada- Wednesday, October 4th, 2006
TORONTO -- The antibiotic Ketek has been linked to liver problems, the worsening of a neuromuscular disorder called myasthenia gravis and fainting in some ...

Sanofi-Aventis Updates Ketek Safety Info In Canada
Easy Bourse (Communiqués de presse)- Wednesday, October 4th, 2006
LONDON -(Dow Jones)- French drugmaker Sanofi-Aventis SA (SNY) has updated its safety information for antibiotic Ketek following consultations with Health Canada ...

DA under pressure to clamp down on clinical trial fraud
NewsTarget.com- Wednesday, July 19, 2006
The FDA has once again been caught red-handed ignoring the dangers of a widely-prescribed drug and compromising the health of millions. Internal email messages have now surfaced about how the FDA pushed the antibiotic drug Ketek despite urgent warnings from its senior drug safety scientists...

Ketek drug scandal reveals pattern of scientific fraud at the FDA
DrugResearcher.com- Tuesday, July 25, 2006
The US Food and Drug Administration (FDA) has outlined a series of imminent changes to the way it evaluates clinical trials in an attempt to clamp down on fraud...

FDA Public Health Advisory regarding Ketek and Liver Damage

            http://www.fda.gov/cder/drug/advisory/telithromycin.htm. 

Deaths Linked to Ketek Spark New Questions About FDA
Los Angeles Times, CA - Jun 16, 2006
... Marketed as Ketek, the antibiotic linked to the liver deaths was approved in 2004 as a treatment for serious respiratory infections that have become ...

Grassley to Confront FDA Officials International News Service

FDA official urged halt to Ketek trial on kids: NYT
Reuters - Jun 8, 2006
NEW YORK (Reuters) - A US health official last month called for French drugmaker Sanofi-Aventis to halt clinical trials of its antibiotic Ketek in children ...

Senator Grassley’s Letter to the FDA:

June 8, 2006

Andrew C. von Eschenbach, M.D.
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. von Eschenbach:

The United States Senate Committee on Finance ("Committee") has jurisdiction over the Medicare and Medicaid programs and, accordingly, a responsibility to the more than 80 million Americans who receive health care coverage, including prescription drugs, under those programs.

I read with great interest and concern today's New York Times article entitled, "Halt Is Urged for Trials of Antibiotic in Children," regarding the recommendations of officials in the Office of Drug Safety ("ODS") at the Food and Drug Administration ("FDA" or "the agency") and a consult conducted by Dr. Danny Benjamin, an infectious disease specialist at Duke University. I understand that Dr. Benjamin was asked by the FDA to examine the pediatric trials.

According to the article, a recent internal review of safety reports by ODS officials found 110 cases of liver problems (liver failure and serious liver injury) associated with telithromycin ("Ketek"), since the antibiotic was approved in April 2004. It is alarming that most of these serious events occurred in otherwise healthy people. Based on their review, these officials recommended that the FDA "consider forcing Sanofi-Aventis [the manufacturer of Ketek] to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects."

The New York Times further reports that in light of the risk of fatal liver failure, blurred vision and loss of consciousness, Dr. Rosemary Johann-Liang, an FDA official in ODS, questioned the agency's decision to allow pediatric trials of Ketek to proceed. She also questioned whether or not it was possible to assess blurred vision and loss of consciousness in very young children. In his separate consult, the article reports that Dr. Benjamin also "concluded that the pediatric trials with Ketek were a cause for concern and 'hard to support.'"

My concern about the safety risks to infants and children was first expressed to you in my letter of April 27, 2006. Now my concerns are even further heightened by the New York Times article on ODS's assessment of adverse events associated with Ketek and Dr. Johann-Liang's and Dr. Benjamin's conclusions regarding the pediatric trials.

Let me reiterate that 6 weeks ago I asked you to advise the Committee of "what action has been taken to fully inform the parents of infants and children enrolled in this study about the risks and benefits of Ketek." Unfortunately, I have not received a response to this important question, and I presume that parents who have enrolled their children in the trials have not been advised of anything either.

Accordingly, as Chairman of the Committee, I request that the FDA respond to the following immediately:

1. Describe the current efforts by the agency to provide parents and patients with updated safety information regarding Ketek and specify the timeframe for implementation of these efforts. If there are no plans to update consent forms and patient brochures at this time, please provide a rationale for the FDA's decision.

2. A search of the ClinicalTrials.gov website shows that Sanofi-Aventis has three ongoing trials in children as young as 6 months old, "TELI COM - Telithromycin in Children With Otitis Media," "TELI TON - Telithromycin in Tonsillitis," and "Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections," and a fourth trial involving adolescents 13 years of age and older, "TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults." Is the FDA considering temporary suspension of these trials until the serious concerns and issues related to Ketek are resolved?

3. Please make available Dr. Rosemary Johann-Liang for an interview with my Committee staff no later than June 28, 2006. Please ensure that Dr. Johann-Liang is provided with a copy of this letter and have your staff contact my staff by no later than June 12, 2006, to make arrangements for the interview.

Thank you for your attention to this very important matter. I look forward to hearing from you regarding my questions and concerns immediately. The adverse events identified with Ketek are serious ones and the possibility that any six-month old child is being exposed to these kinds of risks unnecessarily is unconscionable.

Sincerely,
Charles E. Grassley
Chairman

If you or a loved one developed liver disease or failure, or symptoms of liver failure, during or after treatment with Ketek®, please click HERE for information about your potential legal rights.