WASHINGTON The U.S. Food and Drug Administration on Thursday recommended tighter restrictions on products that contain hydrocodone, an opioid painkiller present in commonly prescribed, potentially addictive drugs such as Vicodin.
Until now, Vicodin and other products that contain less than 15 milligrams of hydrocodone have been classified as Schedule III controlled substances. The FDA recommends reclassifying them more restrictively -- potentially as Schedule II products, in line with opioid pain-killers such as oxycodone and morphine.
Reclassifying the products would make them harder to obtain, both by addicts and by legitimate pain patients. Physicians are not allowed to call in a prescription for a Schedule II product to a pharmacy. Instead, patients must present a written prescription.
In addition, patients would not be allowed as many refills before returning to see their doctors, potentially representing a hardship for patients in chronic pain.
The proposed change was urged by the Drug Enforcement Administration, which is battling a rising tide of prescription drug abuse. The change must be approved by the Department of Health and Human Services and the DEA, which will make a final scheduling decision.
Opponents of the rule change, including many physicians, have argued for years that restricting pain products further could cause hardship to pain patients, especially the elderly.
Proponents argue that the death toll from abuse is unacceptably high.
Nearly three of four prescription drug overdoses are caused by opioid pain-killers, according to data from the Centers for Disease Control and Prevention.
Regulators are trying to tackle the problem from a variety of angles. In an attempt to restrict supply, the DEA has been putting pressure on wholesale suppliers of prescription drugs to police their customers better.
Several companies, including Pfizer Inc and Endo Health Solutions, have been working to develop tamper resistant opioids that cannot be easily crushed or dissolved by addicts looking to get a full dose of the drug quickly.
The misuse of prescription pain-killers 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.
In January a panel of outside medical experts voted 19 to 10 to reclassify the products. The vote followed two days of discussions.
Dr. Janet Woodcock, director of the FDA's pharmaceuticals division, said in a statement that the agency has, over the past few years, been "challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse."
In the end, she said, the level of opioid abuse and the "tremendous amount of public interest" in the matter led the agency to recommend a change.
(Editing by Dan Grebler)