clear
Tuesday June 30th, 2015 8:48AM

FDA wants limits on most prescribed painkillers

By The Associated Press
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 2015 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
S&P 500 index has its best year since 1997
The stock market closed out a record year with more all-time highs on Tuesday, giving U.S. indexes their biggest annual gains in almost two decades.
6:56PM ( 1 year ago )
Colorado readies for 'Green Wednesday' pot sales
Police were adding extra patrols around pot shops in eight Colorado towns that plan to allow recreational sales to anyone over 21 on Jan. 1.
1:52PM ( 1 year ago )
Kerry seeks framework for Mideast peace talks
A senior State Department official says Secretary of State John Kerry will try this week to get Israel and the Palestinians to agree on a framework for negotiating a final peace agreement, yet cautions against raising expectations for Kerry's latest round of shuttle diplomacy.
1:35PM ( 1 year ago )
U.S. News
Missing Ga. bank director arrested in Brunswick
A bank director accused of losing millions of investors' dollars before vanishing last year was arrested Tuesday during a traffic stop in a city in south Georgia.
7:00PM ( 1 year ago )
Amtrak to suspend some Crescent service in Jan., Feb.
Amtrak service will shut down in parts of the Southeast for several days in January and February for rail maintenance by Norfolk Southern Railway.
9:00AM ( 1 year ago )
Lung cancer scans urged for some smokers, not all
Certain current or former heavy smokers should start getting yearly scans for lung cancer to cut their risk of death from the nation's top cancer killer, government advisers said Monday - even as they stressed that the tests aren't for everyone.
7:26AM ( 1 year ago )
Business News
Sex offender held in Hall County for failing to register
A 47-year-old man was booked into the Hall County Jail Tuesday, being held without bond for allegedly failing to register as a sex offender, his second such arrest.
6:09PM ( 1 year ago )
Pharmacy robberies may involve same suspect
Oakwood Police Tuesday afternoon released details in a pharmacy robbery they're investigating, similar to one that happened in the Hall County Tuesday morning.
5:46PM ( 1 year ago )
Victim critical following apartment fire
A 41-year-old woman was in critical but stable condition Tuesday after being rescued from an apartment fire in Forsyth County late Monday afternoon.
3:16PM ( 1 year ago )
Local/State News
Feeling US snub, Saudis strengthen ties elsewhere
Increasingly vocal in its frustration over U.S. policies in the Mideast, Saudi Arabia is strengthening ties elsewhere, seeking out an alignment that will bolster its position after it was pushed to the sidelines this year.
4:34PM ( 1 year ago )
NSA reportedly intercepts computer deliveries
A German magazine has lifted the lid on the operations of the National Security Agency's hacker unit, revealing how American spies intercepted computer deliveries, exploited hardware vulnerabilities, and even hijacked Microsoft's bug report system to spy on their targets.
12:31PM ( 1 year ago )
Rockets fired from Lebanon into Israel
Rockets from Lebanon struck northern Israel on Sunday, causing no injuries but sparking an Israeli reprisal shelling in a rare flare-up between the two countries.
12:26PM ( 1 year ago )
Politics
More overtime on the way? Obama proposes broader coverage
The Obama administration is proposing making up to 5 million more people eligible for overtime — its latest effort to boost pay for lower-income workers.
7:57AM ( 51 minutes ago )
Christie back at high school to announce 2016 run
NEWARK, N.J. (AP) — New Jersey Gov. Chris Christie, who spent three years as president of his high school class, is returning to his alma mater to announce he's running for president of his country.Th...
6:45AM ( 2 hours ago )
Minority leaders form "Black-Brown Alliance" to oppose at-large voting
More than 20 people, including leaders in the African-American and Latino communities, gathered in a conference room at the Newtown Florist Club in Gainesville to discuss the city's at-large voting system.
5:56PM ( 14 hours ago )
Price Road house destroyed in fire
Hall County Fire Services responded to the 5200 block of Price Road on the report of a barn fire Monday morning.
4:16PM ( 16 hours ago )
GSP searches for vehicle involved in hit-and-run that critically injured man
The Georgia State Patrol is asking for some help from the public as troopers search for a vehicle that struck a 64-year-old man on Clarks Bridge Road last Thursday.
2:34PM ( 18 hours ago )