FDA urges tighter controls on certain prescription painkillers - 21 News Now, More Local News for Youngstown, Ohio -

FDA urges tighter controls on certain prescription painkillers

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

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.
  • More From wfmj.comMore>>

  • $2M offered to Ohio farmers to help reduce algae

    $2M offered to Ohio farmers to help reduce algae

    Tuesday, August 19 2014 10:07 PM EDT2014-08-20 02:07:19 GMT
    TOLEDO, Ohio (AP) - The federal government is offering $2 million to Ohio farmers to help prevent farm runoff that contributes to potentially harmful algae blooms. Farmers in 20 counties in the western Lake Erie watershed can apply for some of the funds to plant cover crops to reduce nutrient runoff and erosion. The federal money, provided by the Natural Resources Conservation Service, is aimed at reducing future algae blooms. U.S. Sen. Sherrod Brown and Toledo Rep. Marcy Kaptur announced th...More >>
    TOLEDO, Ohio (AP) - The federal government is offering $2 million to Ohio farmers to help prevent farm runoff that contributes to potentially harmful algae blooms. Farmers in 20 counties in the western Lake Erie watershed can apply for some of the funds to plant cover crops to reduce nutrient runoff and erosion. The federal money, provided by the Natural Resources Conservation Service, is aimed at reducing future algae blooms. U.S. Sen. Sherrod Brown and Toledo Rep. Marcy Kaptur announced th...More >>
  • 5K-8K gallons of fuel oil spills into Ohio River

    5K-8K gallons of fuel oil spills into Ohio River

    Tuesday, August 19 2014 10:06 PM EDT2014-08-20 02:06:15 GMT
    CINCINNATI (AP) - An estimated 5,000 to 8,000 gallons of fuel oil spilled into the Ohio River, closing about a 15-mile section of the waterway southeast of Cincinnati. A Coast Guard spokeswoman says that the section of river was closed to river traffic Tuesday to enable cleanup and response. A Duke Energy spokeswoman says the spill from a Duke power plant in New Richmond, about 20 miles southeast of Cincinnati, happened late Monday night. Duke Energy spokeswoman Sally Thelen says the spill oc...More >>
    CINCINNATI (AP) - An estimated 5,000 to 8,000 gallons of fuel oil spilled into the Ohio River, closing about a 15-mile section of the waterway southeast of Cincinnati. A Coast Guard spokeswoman says that the section of river was closed to river traffic Tuesday to enable cleanup and response. A Duke Energy spokeswoman says the spill from a Duke power plant in New Richmond, about 20 miles southeast of Cincinnati, happened late Monday night. Duke Energy spokeswoman Sally Thelen says the spill oc...More >>
  • Couple stabbed at Ohio home; adult son charged

    Couple stabbed at Ohio home; adult son charged

    Tuesday, August 19 2014 10:03 PM EDT2014-08-20 02:03:06 GMT
    WESTLAKE, Ohio (AP) - A 22-year-old man suspected of stabbing his parents at their suburban Cleveland home has been charged with felonious assault. Westlake police said in a statement Tuesday that a 58-year-old man was flown to a Cleveland hospital with life-threatening injuries, and his 56-year-old wife was in stable condition. Police say authorities learned about the stabbings after a hang-up 911 call Monday night and a subsequent callback by a dispatcher. The couple's son was arrested wit...More >>
    WESTLAKE, Ohio (AP) - A 22-year-old man suspected of stabbing his parents at their suburban Cleveland home has been charged with felonious assault. Westlake police said in a statement Tuesday that a 58-year-old man was flown to a Cleveland hospital with life-threatening injuries, and his 56-year-old wife was in stable condition. Police say authorities learned about the stabbings after a hang-up 911 call Monday night and a subsequent callback by a dispatcher. The couple's son was arrested wit...More >>
Powered by WorldNow
All content © Copyright 2000 - 2014 Worldnow and WFMJ. All Rights Reserved. For more information on this site, please read our Privacy Policy and Terms