US orders halt to unapproved quinine drug sales
Source: Reuters
WASHINGTON, Dec 12 (Reuters) - U.S. regulators on Tuesday ordered companies to stop selling unapproved drugs containing quinine, which is approved only in one anti-malaria drug and can have serious side-effects. The only FDA-approved quinine drug is Qualaquin, sold by Mutual Pharmaceutical Company Inc. to treat malaria. But companies have been selling unapproved versions for malaria, leg cramps and other uses, Food and Drug Administration officials said. Just 0.5 percent of the estimated 4 million annual prescriptions for quinine are for malaria, the FDA said. Serious side effects of quinine can include abnormal heart beats, severe allergic reactions and a decrease in blood cells that can cause hemorrhage, the FDA said. The drug can also have serious interactions with other medicines. Since 1969, the FDA has received 665 reports of serious health problems in patients who took a quinine product, including 93 deaths. Because of the risks, quinine should not be used to prevent or treat leg cramps, the FDA said. Companies that sell quinine products must stop manufacturing them within 60 days, the FDA said. The action is part of an FDA effort to force unapproved medicines from the market.
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