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FDA Wants Limits On Most Prescribed Painkiller

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WASHINGTON (AP) – 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 U.S.

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 like 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 opioids drugs. The FDA did not issue a formal announcement about its decision, which has long been sought by many patient advocates, doctors and lawmakers.

Hydrocodone has long been easier to prescribe, in part, because it is only sold in combination pills and formulas with non-addictive ingredients like aspirin and acetaminophen.

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

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 blockbusters drugs like Vicodin as well as dozens of other generic formulations.

It also consistently ranks as the first or second most-abused medicine in the U.S. each year, according to the DEA, alongside oxycodone.
The FDA has long supported the more lax prescribing classification for hydrocodone, which is also backed by professional societies like the American Medical Association.

But the agency’s top drug regulator, Dr. Janet Woodcock, said in a statement Thursday: “The FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”

In early December, the FDA says it will formally request that hydrocodone be rescheduled as a Schedule II drug, limiting which kinds of medical professionals can write a prescription and how many times it can be refilled.

The Controlled Substances Act, passed in 1970, put hydrocodone drugs in the Schedule III class, which is subject to fewer controls. Under that classification, a prescription for Vicodin can be refilled five times before the patient has to see a physician again. If the drug is reclassified, patients will only be able to receive a single 90-day prescription, similar to drugs like OxyContin. The drug could also not be prescribed by nurses and physician assistants.

The FDA’s request for reclassification must be approved by administration officials in the Department of Health and Human Services.

News of the FDA decision was applauded by lawmakers from states that have been plagued by prescription drug abuse, many who have been prodding the agency to take action for months.

“Today was a tremendous step forward in fighting the prescription drug abuse epidemic that has ravaged West Virginia and our country,” said Democratic Sen. Joe Senator Manchin, in a statement. “Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities.

Sen. Charles Schumer of New York noted that the FDA’s own expert panel recommended the reclassification more than nine months ago.
“Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs,” Schumer said in a statement.

Still, Thursday’s action is likely to face opposition from many physicians and pharmacists. Some professional groups argue that the tighter restrictions could have unintended consequences, burdening doctors with extra work and driving addicted patients to obtain the drugs illegally.

(© Copyright 2013 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten or redistributed.)

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