FDA wants limits on most prescribed painkillers - 21 News Now, More Local News for Youngstown, Ohio -

FDA wants limits on most prescribed painkillers

Posted: Updated:

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 Administration 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 like aspirin and acetaminophen.

That ease of access has made it many health care professionals' top choice for treating chronic pain, everything 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 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. 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.

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."

The FDA says it will formally request in early December 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 to Schedule II, patients will only be able to receive one 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 officials in other agencies within 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 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 immediately sparked criticism from some professional groups that said that the tighter restrictions could have unintended consequences, such as burdening health care workers and patients.

"The FDA's reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care," said Kevin Schweers, a spokesman for the National Community Pharmacists Association.

Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

  • More From wfmj.comMore>>

  • Lightning kills boy swimming in Pennsylvania creek

    Lightning kills boy swimming in Pennsylvania creek

    Monday, September 1 2014 3:09 PM EDT2014-09-01 19:09:34 GMT
    Authorities say a lightning strike has killed a boy who was swimming in a central Pennsylvania creek.More >>
    Authorities say a lightning strike has killed a boy who was swimming in a central Pennsylvania creek.More >>
  • Ohio police: Wedding guest tries to steal gifts

    Ohio police: Wedding guest tries to steal gifts

    DAYTON, Ohio (AP) - Police in Dayton say a wedding guest tried to make off with checks and cash for the newlyweds. Officers were called to the wedding reception late Saturday night after workers noticed that a safe had been emptied out. Police say about $6,800 was found in unopened wedding cards inside a tuxedo garment bag belonging to one of the guests. A police report says surveillance video showed a man entering the office and later walking out with the garment bag. The man told police he...More >>
    DAYTON, Ohio (AP) - Police in Dayton say a wedding guest tried to make off with checks and cash for the newlyweds. Officers were called to the wedding reception late Saturday night after workers noticed that a safe had been emptied out. Police say about $6,800 was found in unopened wedding cards inside a tuxedo garment bag belonging to one of the guests. A police report says surveillance video showed a man entering the office and later walking out with the garment bag. The man told police he...More >>
  • Flying club remembers 4 killed in Ohio plane crash

    Flying club remembers 4 killed in Ohio plane crash

    CLEVELAND (AP) - Members of a flying club held a candlelight vigil to remember four Ohio college students killed a week ago when a small plane crashed just after taking off near Cleveland. Friends and family members were among the 80 people who gathered Sunday night near the crash site in Willoughby Hills. Federal officials say the pilot of the plane reported he was having trouble climbing just after takeoff and was trying to return to the airport. All four people aboard the plane were stude...More >>
    CLEVELAND (AP) - Members of a flying club held a candlelight vigil to remember four Ohio college students killed a week ago when a small plane crashed just after taking off near Cleveland. Friends and family members were among the 80 people who gathered Sunday night near the crash site in Willoughby Hills. Federal officials say the pilot of the plane reported he was having trouble climbing just after takeoff and was trying to return to the airport. All four people aboard the plane were stude...More >>
Powered by WorldNow
All content © Copyright 2000 - 2014 Worldnow and WFMJ. All Rights Reserved. For more information on this site, please read our Privacy Policy and Terms