New drugs raise old concerns

The abuse of prescription painkillers has reached epidemic proportions in America.

Nearly half of the nation’s 38,329 drug overdose deaths in 2010 involved painkillers like hydrocodone and oxycodone, according to the Centers for Disease Control and Prevention. The New York Times reports that: “These narcotics now kill more adults than heroin and cocaine combined, sending 420,000 Americans to emergency rooms each year.images-1

“So many state health officials and advocacy groups were incredulous last fall when the Food and Drug Administrationapproved an even more powerful prescription painkiller — against the advice of its own expert advisory committee.The drug is Zohydro ER, a long-acting formulation of the opioid hydrocodone. The short-acting form, sold under brand names like Vicodin and Lortab, is already the most prescribed drug in the country, and the most abused.In March, Gov. Deval Patrick of Massachusetts sought to ban Zohydro outright, calling it “a potentially lethal narcotic painkiller.” The manufacturer, Zogenix of San Diego, went to court, and last week a federal judge struck down the ban pending further legal action.But other states in New England are moving to restrict the use of Zohydro, and 29 state attorneys general have asked the F.D.A. to reconsider its approval.“People are fearful this will be another original OxyContin,” said Sharon Walsh, director of the Center on Drug and Alcohol Research at the University of Kentucky, referring to an early formulation of the painkiller that resulted in a wave of prescription drug deaths in the 1990s and early 2000s. (OxyContin is now available in an abuse-deterrent formulation.)Zohydro is pure hydrocodone in an extended-release formulation. It is intended for people suffering from chronic pain who now must take short-acting hydrocodone pills every few hours around the clock. Since it does not contain acetaminophen, the new drug will provide steady relief without the risk of liver damage, according to officials at Zogenix. Dr. Bradley Galer, chief medical officer for Zogenix, said the company had fulfilled all of the F.D.A.’s requirements for approval, and there was no reason to treat the medication differently from other extended-release opioids already on the market.

“But critics note that Zohydro is being made available in doses of up to 50 milligrams of hydrocodone — or five times greater than the largest doses of immediate-release pills. Moreover, Zohydro is sold in capsules that can be crushed into doses to be snorted, injected or sold.And it is not available in an abuse-resistant formulation, though company officials say they are doing research to develop one. At the moment, the company is offering pill bottles with combination locks on the caps, as well as lockboxes for storing the drug.F.D.A. officials say they have an obligation to approve new treatment options for the more than 100 million Americans who live with chronic pain, which can be debilitating and can prevent them from working and living productive lives, though that figure has been questioned.”

http://well.blogs.nytimes.com/2014/04/21/new-painkiller-rekindles-addiction-concerns/?_php=true&_type=blogs&ref=todayspaper&_r=0

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