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(Source: Multnomah County Sheriff's Office - Faces of Meth™) |
Citing Overdoses, Lawmakers Ask FDA for Stronger Methadone Warnings
Methadone, long used to treat opiate addiction, has become increasingly popular as a prescription painkiller. But as use has risen so have overdoses, and now a pair of U.S. senators is asking for stronger warning labels on the drug.
The Charleston (W.Va.) Gazette reported June 10 that Sens. Charles Grassley (R-Iowa) and Jay Rockefeller (D-W Va.) said that doctors and the public need to hear more forceful warnings from the FDA about the misuse of methadone and the risks of overdosing on the drug. In 2003, nearly 3,000 deaths nationally were attributed to methadone use, up from 790 in 1999.
"What's happening with methadone underscores how serious it is that the FDA make dramatic improvements to how it scrutinizes drugs after they're on the market," Grassley said. Added Rockefeller: "The serious problem of methadone overdose requires much greater scrutiny and the FDA needs to immediately improve its oversight efforts. For far too long the FDA has been lax on drug safety, which is unacceptable for an agency whose mission is to protect consumers. If the FDA fails to act quickly, Congress must step in and force the FDA to do its job."
Doctors like using methadone as a painkiller because it is inexpensive and effective, but the drug is now blamed for more overdose deaths in the U.S. than heroin -- and far more than are attributed to oxycodone, morphine, and other opiate-based painkillers.
Many of the overdose victims stole the drug or took it improperly, but some died even though they took the drug as prescribed. Critics say the dosage language on methadone packaging, which calls for adults to take "2.5 mg to 10 mg every three or four hours as necessary," can be fatally misleading.
Patients who are not used to powerful painkillers could die if they take 50 mg in a day, and "most people would die if they took 80 milligrams a day," said pain researcher Lynn Webster. "That's an extremely dangerous, liberal guideline."
The FDA said it was working with drug companies on changing the labels, but Roxane Laboratories, one of the biggest manufacturers of methadone, said the firm had not been contacted by the agency.
Some have called on the FDA to issue a public-health advisory on methadone, but an agency spokesperson would not say if such a warning was coming.
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