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.
Since 1969, quinine drugs have been linked to 665 reports of serious adverse events, including 93 deaths, according to the FDA.
Many of the unapproved drugs now sold entered the market before later changes to federal law that now require medicines to be tested for safety and effectiveness before gaining FDA approval. The FDA estimates that the several hundred unapproved drugs on the market account for about 2 percent of prescriptions written each year.
Messages left with Watson Pharmaceuticals Inc. of Corona, Calif. and Ivax Corp. of Miami, now part of Israel’s Teva Pharmaceutical Industries Ltd., were not immediately returned.
The companies are among the eight that the FDA said have made or sold unapproved quinine products. The agency added that some manufacturers already have stopped selling the drugs; it wasn’t immediately clear if the two companies were among them.
Also Tuesday, the FDA said interstate shipments of unapproved quinine drugs must cease within 180 days.
