FDA urges tighter controls on certain prescription painkillers - KPLC 7 News, Lake Charles, Louisiana

FDA urges tighter controls on certain prescription painkillers

Updated: Oct 25, 2013 09:42 AM
© iStockphoto.com © iStockphoto.com
  • HealthMore>>

  • FDA to propose e-cigarette regulations

    FDA to propose e-cigarette regulations

    © FDA© FDA
    The U.S. Food and Drug Administration is proposing long-awaited regulations governing the fast-growing electronic cigarette industry.More >>
    The U.S. Food and Drug Administration is proposing long-awaited regulations governing the fast-growing electronic cigarette industry.More >>
  • People seek out health info when famous person dies

    People seek out health info when famous person dies

    WEDNESDAY, April 23, 2014 (HealthDay News) -- The deaths of well-known people offer an opportunity to educate the general public about disease detection and prevention, a new study suggests. Researchers surveyed 1,400 American men and women after Apple co-founder Steve Jobs died of pancreatic cancer in 2011 and learned that more than one-third of them sought information about his cause of death or information about cancer in general soon after his death was reported. About 7 percent of th...More >>
    WEDNESDAY, April 23, 2014 (HealthDay News) -- The deaths of well-known people offer an opportunity to educate the general public about disease detection and prevention, a new study suggests. Researchers surveyed 1,400 American men and women after Apple co-founder Steve Jobs died of pancreatic cancer in 2011 and learned that more than one-third of them sought information about his cause of death or information about cancer in general soon after his death was reported. About 7 percent of th...More >>
  • 1 in 13 U.S. schoolkids takes psych meds

    1 in 13 U.S. schoolkids takes psych meds

    More than 7 percent of American schoolchildren are taking at least one medication for emotional or behavioral difficulties, a new government report shows.More >>
    More than 7 percent of American schoolchildren are taking at least one medication for emotional or behavioral difficulties, a new government report shows.More >>

By Dennis Thompson
HealthDay Reporter

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 Research.

The agency struggled over the impact that the change might have on patients, she said, but decided that public health concerns have become paramount.

"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 Times reported.

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 control.

"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 drugs.

More information

There's more on the dangers of prescription painkiller abuse at the U.S. Centers for Disease Control and Prevention.

Copyright © 2013 HealthDay. All rights reserved.

*DISCLAIMER*: The information contained in or provided through this site section is intended for general consumer understanding and education only and is not intended to be and is not a substitute for professional advice. Use of this site section and any information contained on or provided through this site section is at your own risk and any information contained on or provided through this site section is provided on an "as is" basis without any representations or warranties.
Powered by WorldNow