FDA panel seeks controls on hydrocodone products to curb abuse

Fri Jan 25, 2013 6:57pm EST

* FDA panel votes 19-10 to tighten hydrocodone restrictions

* FDA typically follows advice of advisory panels

* Products include Vicodin, certain cough suppressants

* Rules would class products as Schedule II substances

Jan 25 (Reuters) - A U.S. Food and Drug Administration advisory panel has called for tighter restrictions on products that contain hydrocodone, an opioid painkiller present in commonly-prescribed drugs that are potentially addictive.

The panel of outside medical experts voted 19 to 10 on Friday to reclassify such products to make them more difficult to obtain. The move comes at a time when deaths from prescription drugs are soaring in the United States.

The recommendation by the panel followed two days of discussions prompted by a request from the U.S. Drug Enforcement Administration to have hydrocodone-containing painkillers such as Vicodin classified as Schedule II controlled substances.

This group includes opioid painkillers such as oxycodone and morphine as well as certain stimulants that have a high potential for abuse. Until now, Vicodin and other products that contain less than 15 milligrams of hydrocodone have been classified as Schedule III controlled substances, a less restrictive category.

The challenge facing U.S. regulators is to keep the powerful and potentially addictive painkillers out of the hands of those who do not have a legitimate medical need for them, while protecting access to the drugs for patients with legitimate pain.

If the FDA follows the advice of its advisory panel, as it usually does, hydrocodone-containing drugs will be harder to obtain. Physicians, for example, are not able to call in a prescription for a Schedule II product. Instead, patients must present a written prescription.

Opponents of the rule change argue that such a requirement could cause hardship to legitimate patients, especially the elderly. But proponents argue that the death toll from abuse of opioids is unacceptably high.

Nearly three out of four prescription drug overdoses are caused by opioid painkillers, according to data from the Centers for Disease Control and Prevention.

Regulators are trying to tackle the problem from a variety of angles. For example, in an attempt to restrict supply, the DEA has been putting pressure on wholesale suppliers of prescription drugs to better police their customers.

Several companies, including Pfizer Inc and Endo Health Solutions are working to develop tamper resistant opioids that cannot be easily crushed or dissolved by addicts looking to quickly get a full dose of the drug.

Yet the problem continues. The misuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years, according to the CDC.

FILED UNDER:
We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/
Comments (1)
Toouncommon wrote:
This is a draconian response that will harm patients, particularly the elderly. Pain killers are hard to get legally. Some individuals do abuse them and a very small portion of the doctors are dispensing them illegally. Making them harder for legitimate users to obtain will only increasing pain and suffering or NON abusers.

Yes, punish those who break the law. But do not make millions of people suffer because of the actions of less than one percent of users!

The big problem with hydrocodone is that it is usually compounded with acetomenacin, the generic form of Tylenol. In large quantities, it can harm the liver. In elderly patients, this is a very bad thing.

Because of legal scrutiny, doctors are reluctant to prescribe it without acetometacin so many of the deaths described in these statistics are really because of liver damage, not because these are junkies.

Let’s not make grandma suffer to punish junkies. It would be preferable to let the junkies to die because of their stupidity than to make the elderly, who NEED pain killers, become suicidal because of daily pain. Keep Vicodin and other medicinal pain killers legal!

Someday it might be you who needs it.

Jan 27, 2013 10:44am EST  --  Report as abuse
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.