QDIS Blog

Although I’ve not directly mentioned the Sanofi antibiotic Ketek (telithromycin), I did mention it in my post State of the Pharmaceutical Industry. Back on May 01, 2006, some in Congress raised concerns about it due to liver toxicity. It is interesting to note that the FDA turned down the new drug application not once, but twice (in 2001 and 2003) before approving it, ironically on April 1st, 2004. There are also questions surrounding one of the clinical trials and one doctor in Alabama pleaded guilty of fraud and served time in jail.

Now, in this article of May 19, the FDA is looking at changing the labeling for Ketek and may add a “black box” warning. This is the most serious of the various possibilities.

Sanofi, FDA in talks on Ketek label after concerns | Reuters.com

The drug has been linked to 12 cases of liver failure and 4 deaths and the FDA is in talks with Sanofi concerning changes to the label. It should be noted that the FDA is recommending changing the labeling and NOT product withdrawal so they must feel it has some usefulness. Accroding to Sanofi, these talks have been underway for “some months”. Here’s the FDA Q&A page on Ketek:

Telithromycin (marketed as Ketek) Questions and Answers
Here is the current labeling:

Ketek approved label (from the FDA website)
Ketek labeling from Sanofi’s website

Interestingly, the chemical structure is missing from the FDA pdf file but is in the Sanofi version which is why I’ve included both. It is in the class of macrolide antibiotics of which there are several on the market.

This brings us to the topic of how drugs get their labeling. It is interesting to note that these sorts of issues can sometimes lead to long drawn out “talks” before an agreement is worked out. The problem is, the FDA can’t force manufacturers to add certain words to the label and the process usually involves a lot of negotiation. I can understand the concern for medicines where an alternative may not be available or where there is only one alternative, but in instances where there a number of alternatives and all or most appear to be considerably safer, I fail to see why there should be long delays that may result in more deaths or injuries. I think a true assessment of risk vs reward for the public at large gets overlooked in the process.

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