WASHINGTON Oct 24 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
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
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
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
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
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.