FDA panel seeks controls on hydrocodone products to curb abuse
* 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.
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