THURSDAY, Oct. 24 (HealthDay News) -- The U.S. Food and Drug
Administration has recommended tighter controls on prescriptions
for painkillers such as Vicodin and Lortab that contain the
powerful narcotic hydrocodone.
The change will cut in half the number of refills that patients
can get before seeing their doctor to get a new prescription, the
agency said Thursday.
Patients also will have to take a prescription to their pharmacy
to have it filled, rather than have a doctor call it in.
The FDA announced that it will also ask in mid-December that all
prescription medications containing hydrocodone be reclassified as
"Schedule II" medications.
As Schedule II drugs, these painkillers will be subject to the
same type of strict control as other narcotics with the highest
potential for abuse, including OxyContin, methadone, fentanyl,
Adderall and Ritalin.
The FDA has been spurred to action by epidemic levels of
prescription drug abuse in the United States, said Dr. Janet
Woodcock, director of the agency's Center for Drug Evaluation and
The agency struggled over the impact that the change might have
on patients, she said, but decided that public health concerns have
"These are very difficult tradeoffs that our society has to make," Woodcock told The New York Times. "The reason we approve these drugs is for people in pain. But we can't ignore the epidemic on the other side."
One out of every five Americans has used prescription drugs for
non-medical purposes at some time, according to the U.S. National
Institutes of Health. Some 22 million Americans have misused
prescription painkillers since 2002.
About 131 million prescriptions for medications containing
hydrocodone were issued to an estimated 47 million patients in
2011. According to government estimates, that's equivalent to about
5 billion pills, the
Dr. Lynn Webster, president of the American Academy of Pain
Medicine, said: "This decision will mean there will be far less
hydrocodone prescribed, and far less of it diverted [for abuse].
There will be an increase in health care costs due to more frequent
office visits and co-pays, but it will take a bite out of the
prescription drug crisis. We can't have status quo. We can't be
doing what we have been doing for the last two decades."
The new regulations could take effect as early as next year,
Woodcock said. The U.S. Department of Health and Human Services
must approve the recommendation before it can be adopted by the
U.S. Drug Enforcement Administration, which has been pushing for
tougher regulation of hydrocodone medications.
Patients currently can refill a prescription for a drug
containing hydrocodone five times during a six-month period before
having to return to their doctor for a new prescription.
The new regulations would cut that period down to three months
before a new prescription is required.
Public health experts supported the FDA's decision.
"There's no question that these are important changes in the right direction," said Dr. G. Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins School of Public Health in Baltimore. "The FDA plays a critical role in helping to reduce the toll that this epidemic has taken. The clinical community and public health community will welcome these changes."
However, Alexander said doctors and regulators need to keep an
eye on problems for patients that result from the tighter
"The bottom line is these kind of complex policies are often hard to predict," he said. "They can have both intended or unintended consequences."
Earlier this year, an FDA advisory panel voted 19 to 10 in favor
of reclassifying hydrocodone-based painkillers as Schedule II
There's more on the dangers of prescription painkiller abuse at
U.S. Centers for Disease Control and
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