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FDA Restricts Opioid Painkillers to Combat Epidemic of Abuse


September 11, 2013 — In response to a growing epidemic of prescription painkiller abuse, the U.S. Food and Drug Administration (FDA) has published new guidelines for prescribing long-acting opioid painkillers, such as oxycodone. They have removed the indication for “moderate” pain. They have also required new clinical trials and added a Boxed Warning about the risk of infant withdrawal in pregnant women who use the drugs.

The FDA will recommend only prescribing long-acting opioid painkillers for:

“…the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

In the last decade, the use and abuse of opioid painkillers has skyrocketed in the United States. The Centers for Disease Control (CDC) has reported that over 2 million Americans are addicted to the pills and about 15,000 people die from overdoses every year. In addition, about 12 million Americans admitted using the drugs for non-medical purposes.

The epidemic has paralleled a 300% increase in sales since 1999. The rapid rise in popularity was partly due to research generated by drug companies and aggressive marketing of long-acting pills as less addictive than short-acting pills.

One example of this is Oxycontin (oxycodone). In May 2007, drug-maker Purdue Pharma was fined $700 million by the U.S. Food and Drug Administration Office of Criminal Investigations over a “conspiracy” to promote, market, and sell the drug.

During the 1990s, Purdue marketed OxyContin as safer than other opioids because it had a 12-hour long-acting release mechanism. However, users quickly discovered that chewing or grinding the pills caused the active ingredients to release all at once, leading to a quick and powerfully addictive high. As doctors began prescribing OxyContin for everything from back pain to arthritis, overdoses and addiction became a major public health problem, especially for teenagers and young adults.

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