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FDA acts to fight opioid overdose “epidemic”

methadoneiiDrug manufactures that market opioid painkiller medications will be required to train U.S. doctors, nurses and other health care professionals in the ways of safe use of the drugs, which have caused an epidemic of overdose deaths according to the Center for Disease Control (CDC).

The FDA introduced new safety measures for extended-release and long-acting opioid medications, such as oxycodone, hydrocodone, and methadone.  It comes in the form of a mandated blueprint on best practices measures directed at upwards of 20 companies that manufacture opioid analgesics, including how best to educate physicians who prescribe the medications.

New safety measures come from the FDA after the CDC published myriad striking statistics regarding drastically rising opioid overdose deaths.

The Federal requirement handed down from the FDA comes in the wake of a failed U.S. Congressional bill that went to vote several weeks ago.

“Although many Americans don’t realize it, prescription drug abuse is our swiftest growing drug problem. Many of those abuses involve opioids,” said Dr. Margaret Hamburg, commissioner of the Food and Drug Administration. “In 2008, nearly 15,000 Americans died where opioids were involved. In 2009, that number went up to 16,000.”

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Methadone: Public Enemy No. 1

The opioid class painkiller, methadone, is the cause of one in 3 prescription painkiller overdose deaths, despite accounting for only 2 percent of painkiller prescriptions written, reports Kristina Fiore for MedPage Today.

Methadone took center stage in a recent CDC report.  Approximately 5,000 patients died from methadone overdose in 2009, about six times more than 10 years ago.

“Methadone is riskier than other prescription painkillers … and we don’t think it has a role in the treatment of acute pain,” said Thomas Frieden, director of the CDC.

Frieden explained that the proportion of methadone to other painkiller prescriptions is on the rise because insurers have increasingly made it a top-tier drug for chronic pain since it has such a low cost.  Evidence suggests that the increase in methadone overdoses is directly related to the increased use of methadone to treat chronic pain.

It’s  “penny wise and pound foolish …with higher societal costs in terms of death and other problems that can be avoided” Frieden said adding that there are other, safer opiates that should be used for pain.

Frieden cautioned that there’s limited evidence for the efficacy of opiates on chronic pain that is not related to cancer.

I suppose this is simply another example of insurance companies using a cost/benefit analysis on human life.