FDA panel votes for tougher curbs on vicodin, other painkillers

January 26, 2013 by Amanda Gardner, Healthday Reporter
FDA panel votes for tougher curbs on vicodin, other painkillers
Debate over the move has pitted patients in chronic pain against those fighting drug abuse.

(HealthDay)—A U.S. Food and Drug Administration advisory panel voted Friday to place tougher restrictions on prescription painkillers containing hydrocodone, potentially moving medications such as Vicodin into the same class as narcotics such as Oxycontin and Percocet.

Vicodin (hydrocodone plus ) and other hydrocodone-containing drugs remain widespread targets for abuse, and the U.S. has long requested that the FDA undertake the review. The panel spent two days discussing the issue before voting on Friday afternoon, the Associated Press reported.

Currently, the medications are classified as Schedule III drugs but the DEA wants them placed within the more tightly controlled Schedule II designation, alongside painkillers such as and Percocet.

The FDA is not required to follow the recommendations of its advisory panels, but it typically does.

The issue has become a contentious one.

Supporters of a move to Schedule II status point to tragic deaths and suicides that have been the result of misuse of these .

But, opponents of that tougher classification fear that tightening access to the drugs would mean that people who really need them to ease pain will not be able to get them.

"This is really a decision of access versus diversion [for non-medical use]," explained Dr. Lynn Webster, president-elect of the American Academy of Pain Medicine, who said his organization was not necessarily in favor of or opposed to reclassification.

However, "it will have an impact on a lot of patients who have been receiving them for some time for legitimate purposes" if these drugs are reclassified, Webster added.

Dr. Andrew Kolodny, president of Physicians for Responsible Prescribing, called such concerns "completely bogus."

"Even if we change hydrocodone-containing products from Schedule III to Schedule II, it in no way jeopardizes access," he believes. "What this means is that patients who might be able to go to their doctor every six months would now have to see their doctor every three months [to get a prescription]."

Kolodny also contends that "people who are on long-term opioids are more likely to be harmed by that treatment than helped. There is very little difference between a heroin molecule and a hydrocodone molecule."

Few people seem to dispute the fact that too many of these opioid drugs are too widely available, even though the pharmaceutical industry has recently developed "abuse-resistant" formulations to help fight misuse.

Overall, some 22 million Americans have misused prescription painkillers of one kind or another since 2002, according to a report released earlier this month by the U.S. Substance Abuse and Mental Health Services Administration. The agency noted that now rank only behind marijuana as a of abuse in the United States.

According to Webster, patients typically do not use two-thirds of the hydrocodone-containing medications they've been prescribed, meaning those leftover pills might become available for misuse.

"That suggests that there are way more drugs being prescribed than is necessary," Webster said. "And we know that basically 80 percent of all drugs used for non-medical purposes come from the medicine cabinet at home."

Added Kolodny, who is also chair of psychiatry at Maimonides Medical Center in New York City: "We have an epidemic of people with opioid addiction. That's what's really causing overdose deaths."

According to Kolodny, "changing hydrocodone-combination products from Schedule III to Schedule II may be the single most important federal intervention that could be taken to bring this epidemic under control."

Webster said he remained "seriously concerned about both of these issues [access and diversion]," but also felt that there were alternatives to reclassifying.

"We need more education about how to safely prescribe these drugs and identify people who are safe candidates and prescribe less," he said. "At the same time, we need a national campaign that informs the public and people who are receiving the medications that it's dangerous to have leftover medications and that they need to find ways to dispose of their medications or not accept a prescription."

Explore further: FDA panel weighs tougher restrictions on some prescription painkillers

More information: Visit the U.S. National Library of Medicine for more on prescription drug abuse.

Related Stories

FDA panel weighs tougher restrictions on some prescription painkillers

January 24, 2013
(HealthDay)—A U.S. Food and Drug Administration advisory panel will meet Thursday and Friday to discuss the fate of certain painkillers that contain an opioid known as hydrocodone.

FDA panel wants limits on hydrocodone painkillers

January 25, 2013
Federal health advisors want new restrictions on hydrocodone, the highly addictive ingredient found in Vicodin and other widely abused prescription painkillers.

Senator warns FDA on danger of newest painkillers

January 8, 2012
Following fatal shootings in two New York pharmacy robberies, a U.S. senator is warning that a new batch of "super painkillers" now under review could force repeats of recent violent robberies that left six people dead.

US panel opposes pure hydrocodone painkiller

December 9, 2012
(AP)—U.S. government health experts overwhelmingly voted against a stronger version of hydrocodone on Friday, questioning the need for a new form of one of most widely abused prescription painkillers.

Teach prescribers about dangers of long-acting pain meds: FDA

July 9, 2012
(HealthDay) -- As part of its efforts to curb the abuse of narcotic painkillers, the U.S. Food and Drug Administration is requiring drug makers to educate doctors about the risks of long-acting and extended-release forms ...

Many who first misuse prescription pills get them from friends, family: report

April 25, 2012
(HealthDay) -- A new U.S. government analysis shows that more than 70 percent of people who first misuse prescription medications get those pills from their friends or relatives.

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

2 comments

Adjust slider to filter visible comments by rank

Display comments: newest first

Doug_Huffman
1 / 5 (1) Jan 26, 2013
Regulation of drugs is as effective as regulation of guns is as effective as regulation of all malum prohibitum.
jimh217
not rated yet Jan 29, 2013
I have been a pharmacist in the US for 55 years. During that time I have seen a rapid and sustained increase in laws and regulations concerning controlled substances. There has been no reduction in abuse. If anything, increased prohibition has resulted in an increase in illicit drug trade and drug related crime.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.