FDA Stopping Sale of Some Quinine Drugs

Article in the New York Times — FDA Halts Sales of Some Quinine Drugs, by the Associated Press:

Companies have 60 days to stop selling unapproved prescription drugs made with quinine and dispensed by the millions each year.

The new Food and Drug Administration order, released Tuesday, applies to the roughly eight companies that make and sell the drugs, most commonly prescribed to treat leg cramps. It does not affect the single FDA-approved quinine drug sold to treat some types of malaria.

That FDA-approved medicine, heir to a traditional use of the drug that dates to the 1800s, today accounts for just one-half of 1 percent of the estimated 4 million annual prescriptions written for quinine drugs. Doctors prescribe the vast majority of the drugs for leg cramps, a use that the FDA warned patients and doctors could pose serious safety risks.

Many unapproved quinine drugs don’t bear warnings of those risks, including the toxic effects of even a slight overdose, agency officials said.

BGS