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article imageAgainst medical advice, FDA approves potent new painkiller

By Karen Graham     Nov 15, 2013 in Health
The incidence of fatal overdoses from the use of potent painkillers has reached epidemic proportions in the United States. The use of opioids like OxyContin and Vicodin are now the leading cause of fatal drug overdoses in the U.S..
Against the advice of a Food and Drug Administration (FDA) pain specialists panel and the Centers for Disease Control and Prevention (CDC), Zohydro, an extremely potent opioid painkiller has been approved for sale and use in the United States.
This action has raised fears of the painkiller becoming the new drug of choice for abuse, and the fears are justified, according to the CDC. The opioid painkiller contains pure hydrocodone, at levels that are 10 times higher than the levels found in Vicodin.
Zohydro has been under scrutiny for over a year, especially after the FDA had gone on record, telling drug manufacturers they needed to reformulate many of the potent pain medicines, making them more difficult to abuse, but it wasn't a requirement.
Almost one year ago, in December 2012, a panel of pain specialists with the Food and Drug Administration (FDA) voted 11-2 against the manufacture of a more potent form of hydrocodone, one of the most widely-abused painkillers in the United States. The panels main objection at the time was the increased possibility of the drug being abused.
While the FDA is not obligated to follow the panel's recommendations, they often do. The drug in question was Zohydro, manufactured by Zogenix, a San Diego-based company. It was touted as a treatment for moderate to severe chronic pain, and was formulated to be a long-acting pain reliever.
There are several questions that need to be answered, especially by the FDA and the company responsible for the making of Zohydro. Zogenix, the manufacturer, did not follow FDA recommendations about injecting a gel-like substance into the pills, making it more difficult for them to be crushed and snorted, upping the potential for abuse.
The drug was supposed to be for the use of cancer patients, and again, was not widely tested on this particular group. At the last minute, Zogenix signed a $750,000 contract with a Montreal-based company, Altus Formulation Inc. to come up with a tamper-proof formula. The Canadian company has four months to come up with some kind of formulation before the painkiller goes on the market.
More about oxycodone, addictive, Zohydro, FDA approved, CDC
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