NEWS - FDA halts marketing of most quinine drugs

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FDA halts marketing of most quinine drugs

Monsters and Critics

Dec 12, 2006, 20:00 GMT

WASHINGTON, DC, United States (UPI) -- The U.S. Food and Drug Administration

Tuesday ordered companies to stop marketing unapproved products containing

quinine, a drug used to treat malaria.

The FDA said its action stemmed from safety concerns associated with quinine

products. There are multiple unapproved products containing quinine

currently marketed, but there is only one quinine product approved by the

FDA-- Qualaquin, which is approved to treat certain types of malaria without

complications.

As part of its action, the FDA also cautioned consumers about off-label use

of quinine to treat leg cramps. Quinine is approved for treatment of

malaria, but is also commonly prescribed to treat leg cramps and similar

conditions.

The FDA said because malaria is life-threatening, the risks associated with

quinine use are justified for that condition. But because of the drug`s

risks, the agency said it believes quinine should not be used to prevent or

treat leg cramps.

The governmental government agency said since 1969 it has received 665

reports of adverse events with serious outcomes associated with quinine use,

including 93 deaths.

http://news.monstersandcritics.com/health/news/article_1232552.php/FDA_halts_mar\

keting_of_most_quinine_drugs

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org