FDA bans sale of generic OxyContin due to potential for abuse

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by Heygood Orr and Pearson

The Food and Drug Administration has issued an order banning a generic version of the painkiller OxyContin because of its potential for abuse. The original formulation of OxyContin was approved for sale by the FDA in 1995.

Although the original version of OxyContin was sold in a time-release formula that released the drug’s medication over a 12-hour period, abusers were known to crush the pills so that they could be snorted or injected. This allowed for the medication inside the pill to be absorbed immediately into the bloodstream, rather than over a longer period.

In 2010, the FDA approved a new crush-resistant formula for OxyContin that made the drug more difficult to abuse. Any new generic versions of the drug that are submitted for approval by the FDA must be based on this formula, the agency has announced.

The abuse of OxyContin and other opioid painkillers is a significant problem in the U.S., due in part to the way these drugs are prescribed by physicians. According to the Centers for Disease Control and Prevention, enough prescription painkillers were prescribed in 2010 to keep every adult in the U.S. medicated around the clock for a full month.

The CDC says that prescription painkillers have been responsible for more deaths in the U.S. than heroin and cocaine combined. In 2009, about half a million people went to the hospital after using opioid painkillers such as Duragesic (fentanyl), Vicodin (hydrocodone), OxyContin (oxycodone), Opana (oxymorphone) and methadone.