Last month my pharmacist told me that the prescription of quinine for cramping that she was filling for me would be my last, where the FDA was no allowing its use except in conjuntion with malaria. I didn't lose a lot of sleep over it becasuse it never appeared to be that effective anyhow, and I've got a couple of other drugs (Zanaflex and Baclofen) that give every appearance of being far more effective.

Fast foward to Saturday's New York times, and the following little story:

April 7, 2007

F.D.A. Orders End to Production of a Form of Anti-Nausea Drug

By DONALD G. McNEIL Jr.

The Food and Drug Administration yesterday ordered drug companies to stop making and selling anti-nausea suppositories containing a drug that the agency said did not work when used in that form.

The move was part of a campaign by the agency to re-evaluate drugs approved before 1962, the year drug makers had to start proving that their products worked. Before 1962, they had to prove only that they did no harm.

The suppositories, sold by prescription under the names Tigan, Tebamide, T-Gen, Trimazide and Trimethobenz, all contain the active ingredient trimethobenzamide.

About two million such suppositories are sold each year, said Dr. Jason Woo, an official in the agency’s compliance office.

Trimethobenzamide in other forms, including pills and injectables, does have F.D.A. approval for use against nausea and vomiting, the agency said.

The agency has had evidence since 1979 that trimethobenzamide suppositories do not work. But the review “requires a lengthy analysis,” Dr. Woo said. Also, the drug makers requested a hearing, “which further slowed the process,” he said.

Last June, the agency began “reinvigorating” the process, said Deborah M. Autor, the compliance office’s director.

Since then, it has removed its previous approvals of products containing quinine for leg cramps, ergotamine tartrate for migraines and carbinoxamine for children’s allergies and colds.

Although the agency estimates that less than 2 percent of prescription drugs sold now are unapproved, it believes there are “several hundred” unapproved active ingredients in prescription drugs.

Representatives of the companies making the suppositories could not be reached yesterday because of the holiday. The companies have until May 9 to comply with the F.D.A. order.

Copyright 2007 The New York Times Company [Emphasis added.]

It would appear that the FDA is finally getting around to cleaning up the old bottles in the medicine cabinet.

Mike

Really is about time they did something.

BUT Quinine IS EFFECTIVE.

It might not be for RSD cramping

BUT there is research showing that it is effective for muscle cramps... it's why many people (in the UK) with muscle cramping/ RLS (restless leg syndrome) etc are told to drink tonic water... and are told to drink it without gin (which I feel after about 10 doubles would be a very effective muscle relaxer)!... and why long term trials?! it's been available for over 50 years now....

There may be no "official" data that these drugs work... but at the same time, there is none that they "don;t". Removing them from the shelves because they have decided they want some studies...... surely you could do that with them on the shelves? I only know about quinine, but i know that there is a lot of homeopathic (?)/ natural medicine stuff that shows it is effective...

I guess I am also cynical that this is just a way for pharmaceutical companies to make more money... if you take the old drug off the market it then means that you can bring out a new, twice as expensive one!!

Well, that's only my musings.......

Love Froggsyxxxxxxxxxxxxxxxxx