October 25, 2013

FDA seeks new rules for hydrocodone

The agency recommends restrictions on the highly addictive painkiller that mirror those for other narcotic drugs.

The Associated Press

WASHINGTON — The Food and Drug Administration is recommending new restrictions on prescription medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the United States.

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Hydrocodone pills have become the most widely prescribed drug in the U.S.

The Associated Press

In a major policy shift, the agency said in an online notice Thursday that hydrocodone-containing drugs should be subject to the same restrictions as other narcotic drugs such as oxycodone and morphine.

The move comes more than a decade after the Drug Enforcement Agency first asked the FDA to reclassify hydrocodone so that it would be subject to the same restrictions as other addictive painkilling drugs. The FDA did not issue a formal announcement about its decision, which has long been sought by many patient advocates, doctors and state and federal lawmakers.

For decades, hydrocodone has been easier to prescribe, in part because it is only sold in combination pills and formulas with other non-addictive ingredients such as aspirin and acetaminophen.

That ease of access has made it many health care professionals’ top choice for treating chronic pain, from back pain to arthritis to toothaches.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. The ingredient is found in blockbuster drugs such as Vicodin as well as dozens of other generic formulations.

It also consistently ranks as the first or second most-abused medicine in the United States each year, according to the DEA, alongside oxycodone. Both belong to a family of drugs known as opioids, which also includes heroin, codeine and methadone.

Earlier this year the Centers for Disease Control and Prevention reported that prescription painkiller overdose deaths among women increased about fivefold between 1999 and 2010. Among men, such deaths rose about 3.5-fold. The rise in both death rates is closely tied to a boom in the overall use of prescribed painkillers.

 

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