* 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 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
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
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.