Seems Ketek (telithromycin) made it back in the news a couple of weeks ago.
Enrollment of Children in Drug Study Is Halted - New York Times:
Enrollment of children in drug study suspended - Children’s Health - MSNBC.com
I’ve previously posted about Ketek and how some in Congress, particularly Senator Charles Grassley (R-IA) were concerned about why the FDA approved Ketek when some involved with some studies were found guilty of fraud. Here’s an excerpt from The Blotter (from ABC news):
The study with the forged test results was conducted at a former weight loss clinic in Gadsden, Alabama. Dr. Maria Anne Kirkman-Campbell is serving five years in prison for falsifying safety test results on Ketek.
A former nurse, Michelle Snedeker, told ABC News she was ordered to forge documents and report data on people who had not even been given Ketek. The doctor was paid $400 for each of the 407 subjects that she enrolled for the study.
It has been thought to cause liver problems (not an uncommon occruance for drugs since this is where they are usually metabolized) and now studies in children have been halted. It should be made clear that the FDA is not talking about taking the drug off the market but is performing a safety review, although some officials it seems do have serious concerns. Here’s an exceprt from the New York Times article:
Yesterday, The Times cited internal food and drug agency memorandums that said some safety officials said the F.D.A. should consider forcing Sanofi-Aventis to remove Ketek from the market, severely restrict its use or add a prominent warning label about its potentially fatal side effects.
It is interesting to note the company line regarding why the trials were halted. Here it is from the New York Times article:
The company denied that the studies of the drug, Ketek, were halted because of safety concerns and said that it was only trying to ensure that the trials complied with Food and Drug Administration requirements.
According to Clintrials.gov, there are four studies and all have been halted. Heres the list of the trials:
Clinical Trial: TELI COM - Telithromycin in Children With Otitis Media
Clinical Trial: 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
Clinical Trial: TELI TON - Telithromycin in Tonsillitis
Clinical Trial: TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults
It should be noted that ketek was approved in 2004 and as of april 2006, there have been 110 reported cases of liver problems associated with Ketek, so the number is likely higher since some cases certainly go unreported.
More news results on Ketek (these are sorted by date in both cases):
Yahoo! News Search Results for ketek
ketek - Google News
And here is some search results from other bloggers (also sorted by date):
Yahoo! Search Results for ketek (blog results)
Google Blog Search: ketek antibiotic
The interesting thing on this is that the earliest blog entry mentioning Ketek was back on 21 Mar 2005 for Google blog search and only 13 days ago in Yahoo’s blog search. The earliest news on Ketek in Google dates back to May 22 and for Yahoo the same date.
Regarding the blog search results it is interesting to note how many times Ketek is mention with regard to causing nausea or other possible side effects. Now, I wouldn’t but much faith in random posting to journals and diaries posted on the Internet, but it is worth noting. Now these could happen for a variety of reason and many would not be related to the drug. Still it is more antecedent evidence of possible problems.
Google trends is another interesting way to look at this event. Here’s the graph of search volume. I do think something is wrong with Google trends since it doesn’t report any news events and there have been several including ones found through a Google news search. The two blips in 2004 are certainly related to it’s approval
The interesting thing is the Houston, TX result for both Ketek and telithromycin. My bet (based on previous experience) is that there is a law firm in Houston working on a lawsuit related to Ketek.
Technorati Tags: antibiotics, drug safety, Ketek, telithromycin
Email Ed Vawter
Related Posts:
Ketek Gets New Label WarningConcerns about the antibiotic Ketek labelingFDA Panel Recommends Limited Use for KetekFurther Bad News for Ketek?Sanofi Antibiotic Ketek Said Safe By The FDA
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