QDIS Blog

As regular readers know, I’ve been following the issues surrounding Ketek (telithromycin) an antibiotic from Sanofi-aventis and reports that it has caused some liver problems.

UPDATE 3-Studies support Sanofi antibiotic, say FDA staff | Reuters.com:

The FDA has had meetings Dec 14-15 on this product as a joint meeting involving both the anti-infective drug advisory committee and the drug safety and risk management advisory committee. It will be interesting to see what comes out of this meeting. We may know later today but most likely early next week.

If you want to know the background as well as key dates in the approval history of Ketek then I recommend the Brief documetn listed below which has a lot of good background material on the product.

Once transcripts are available, i’ll post links to them.

Other Resources
FDA Completes Safety Assessment of Ketek New Safety Information to be Added to Product Labeling (press release of June 29, 2006)
Advisory Committees: CDER 2006 Meeting Documents

BRIEFING DOCUMENT AVAILABLE FOR PUBLIC DISCLOSURE: KETEK® (telithromycin)
Technorati Tags: drug safety, FDA, Ketek, Sanofi, Sanofi-Aventis, telithromycin

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This report again highlights that something is wrong with food safety in this country.

Over 250 sick after eating at Indiana Olive Garden - Yahoo! News

Evidently about 250 people in Indiana have become sickened and three people hospitalized after eating at an Olive Garden in Indianapolis. Interestingly, their is nothing on their website yet in the press release area. Although the exact restaurant has not been identified it is most likely this one on 82nd St in Indianapolis near Castleton Square.

If this is indeed caused by e. coli then I think there is very likely some sort of connection between these seemingly unrelated events. According to the report, it will be about 48 hours before any results are know as to what may be the problem.

It could be that the problems at Taco Bell, Taco Johns and Olive Garden all come from a common source. It would not surprise me if it is all the same ingredient (likely lettuce) and that it came from the same geographic source probably in California. This is all just a guess on my part but I certainly hope there is some sort of coordination in this to hopefully trace it back to it origin.

I think this will just add more impetus to Democrats wanting to reform the food safety part of the FDA. I only hope that it doesn’t involve creating a new government agency combining the food aspects of the FDA with the US Dept. of Agriculture’s inspection of meats. AI better solution that I have expressed in the past is to give an adequate budget to the FDA in order to allow them to do their job properly. It may be that the mission of the food safety group needs to be redefined. I would like to see them beef up their inspection force on the food side.

I lived in Indiana for quite a few years so I was interested in what the local TV stations were reporting on this. I’ve listed their reports below. I may even haven eaten at this restaurant at one time. That’s how I know which restaurant it is. There is really only one located in the northeast side of Indianapolis in the Castleton area.

Other Resources

WISH-TV - Indianapolis News and Weather - Update: More than 200 Claim Illness from Restaurant
2 Hospitalized, 200 Report Illness After Eating At Restaurant - Local News

Technorati Tags: FDA, food safety, Olive Garden, Taco Bell, Taco Johns

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The FDA earlier this week ordered several companies to stop selling quinine as a treatment for leg cramps. Many of these companies

FDA halts sales of some quinine drugs - Yahoo! News

Quinine is a useful drug for its intended purpose of treating malaria although this has become less useful recently due to the emergence of resistant strains. Mutual Pharmaceutical Company Inc. is approved to sell Qualaquin for the treatment of malaria. What is interesting to me is that this was just approved on Aug 12, 2005.

This drug has serious side effects and its use for malaria is justified since malaria can be life threatening. However, leg cramps are not life-threatening and therefore the benefit does not outweigh its potential down-side in this situation.

Here is the actual release from the FDA

FDA Advances Effort Against Marketed Unapproved Drugs

This touches on a subject I have posted about before that is off-label use. I think it should be left to doctors to decide a drugs use but in some cases such as this, its use really isn’t justified. The problem is quinine has a narrow therapeutic window. This means the difference between an effective dose and a dose that causes serious side effects is quite small.

There are some drugs out there that have been used in medicine prior to some of the current drug regulations and have not been tested to the current standards. The FDA estimates are that several hundred drugs that are un-approved account for about 2% of all prescriptions written each year.

I have tried to find the companies involved as some articles mention as many as eight companies but the only one currently identified are:

Watson Pharmaceuticals
Ivax (now part of Teva)

These companies have 60 days to stop selling quinine. I would be interested if someone else know the other companies involved.

Other Resource

Questions and Answers About FDA’s Enforcement Action Against Quinine Sulfate Drug Products

Final Rules for Drug Products Containing Quinine for Treatment and/or Prevention of Malaria for Over-the-Counter Human Use (pdf)

Technorati Tags: drug safety, unapproved drugs, quinine

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