QDIS Blog

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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