Navigation Links
FDA Urges Studies on Safer Formulations of Narcotic Painkillers
Date:1/10/2013

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, Jan. 9 (HealthDay News) -- As part of an effort to control the misuse of prescription narcotic painkillers, the U.S. Food and Drug Administration is calling on drug makers to study formulations of the medications that would deter people from abusing them.

"Opioid drugs provide significant benefits for patients when used properly," Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said during an afternoon press conference Wednesday.

However, "opioids also carry a risk of abuse, misuse and death," he said. In 2009, there were nearly 425,000 emergency department visits involving inappropriate use of narcotic painkillers and an estimated 15,600 deaths involving these drugs, Throckmorton added.

The draft guidance the FDA issued Wednesday is designed to let drug makers know what kinds of studies to conduct to measure the effectiveness of the new formulations, and how the agency will evaluate safety claims pharmaceutical companies make about their product.

One issue yet to be dealt with is whether the makers of cheaper generic versions of narcotic painkillers will also be asked to try to produce tamper-free versions of their product.

"This guidance doesn't address generics," Throckmorton said. "What future action we might take with regards to generics in requiring they have abuse- deterrent technologies I simply can't comment on today."

Narcotic painkillers can be abused in many ways, including crushing pills to make them easier to dissolve and inject, the agency explained.

The FDA pointed out, however, that the science of abuse deterrence is relatively new, and ways of making drugs harder to abuse are quickly developing and changing.

If the new formulations meet the requirements for being deemed tamperproof, the drug maker could label its product as being safer, according to the agency.

"Our decision-making will be based on the scientific data that are submitted to us," Throckmorton said. "The FDA intends to take a flexible approach to the evaluation and labeling of these products as the new science evolves."

The FDA is looking for public comments on the draft guidance, and will make its final recommendations later in the year.

"Drug companies are looking at new ways to make it very hard to use a drug [in ways other] than what is intended," said Peter Delany, director of the Center for Behavioral Health Statistics and Quality at the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).

It will take a combined effort from federal and state governments, doctors and other health care professionals to stop the misuse of these drugs, Delany said.

SAMHSA recently released a report that highlights the extent of the prescription-drug-abuse problem state by state. According to that report, some 22 million Americans abused prescription painkillers in 2002.

Pooled data from 2010 and 2011 shows the rates of prescription painkiller abuse for those aged 12 or older ranged from 3.6 percent in Iowa to 6.4 percent in Oregon.

More information

For more on prescription drug abuse, visit the U.S. National Library of Medicine.

SOURCES: Peter Delany, Ph.D., director, Center for Behavioral Health Statistics and Quality, U.S. Substance Abuse and Mental Health Services Administration; Jan. 9, 2013, press conference with Douglas Throckmorton, M.D., deputy director, regulatory programs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. US Drug Watchdog Now Urges Users of Yaz or Yasmin Birth Control Pills Who Suffered A Life Threatening Medical Problem To Call The Johnson Law Group-Immediately
2. US Drug Watchdog Now Urges DePuy Pinnacle Metal Hip Recipients To Get A Blood Test and to Call Them For The Names Of The Best Lawyers If Their Metals Levels Are Elevated
3. Mesothelioma Victims Center Now Urges Families of all Mesothelioma Victims Regardless of Age to Call Them for the Names of the Best Mesothelioma Law Firms-Quality Matters
4. Corporate Whistle Blower Center Now Urges Physicians Medical Device and Drug Industry Insiders To Step Up-If They Have Proof Of Serious Wrongdoing or Overbilling
5. US Drug Watchdog Now Urges Family Members Mourning The Loss Of A Loved One Who Developed Bladder Cancer After Using The Diabetes Drug Actos To Call The Johnson Law Group
6. US Drug Watchdog Now Urges All Recipients Of A All Metal Hip Implant to Get A Blood Test Out of New Concerns About Side Effects and They Name Law Firms To Help Victims
7. Mesothelioma Victims Center Now Urges Diagnosed US Navy Veterans or Their Families to Call Them for the Names of the Best Mesothelioma Law Firms-Don't Get Shortchanged
8. The US Drug Watchdog Now Urges Users Of The Birth Control Pills Yaz-Yasmin to Contact The Johnson Law Group For a Legal Review if They Developed Severe Medical Problems
9. US Drug Watchdog Now Urges a Blood Test for All DePuy Pinnacle Hip Implant Recipients and They Suggest Law Firms to Help Victims of a Failure Get Compensated
10. US Drug Watchdog Now Urges Any Diabetic Who Used the Diabetes Drug Actos and Now Have Been Diagnosed with Bladder Cancer to Call The Johnson Law Group-ASAP
11. US Drug Watchdog Now Urges All Zimmer Stryker, Biomet, Wright and DePuy All Metal Hip Implant Recipients to Get A Blood Test For A Failure-Don't Get Left Holding the Bag
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Urges Studies on Safer Formulations of Narcotic Painkillers
(Date:1/23/2017)... ... 23, 2017 , ... DMG Productions is proud to announce ... scheduled to broadcast Saturday, January 28, 2017 at 5:00pmEST. , This segment will ... address the limitations of fatigue monitoring technologies within the mining industry. Today SmartCap ...
(Date:1/23/2017)... ... January 23, 2017 , ... ... organization in North America for the scientific development, healthcare training and clinical application ... Session, and its 2017 AAT Member Certification Qualification Courses for Technicians, respectively. , ...
(Date:1/23/2017)... ... January 23, 2017 , ... "ProRandom is a set of camera tools that allow video editors ... Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. , ... text with video footage. ProRandom works by using a virtual camera to create the ...
(Date:1/23/2017)... ... January 23, 2017 , ... “Crossing the Bar”: a moving and eloquent ... life. “Crossing the Bar” is the creation of published author, Charlotte Hotte, a North ... who credits the inspiration of the book to her sister, Denise, wishes to acknowledge ...
(Date:1/22/2017)... ... , ... Phytocéane invites clients to take an exotic journey deep into the ... MILKY CREAM. Inspired by the beauty of Zanzibar, a Tanzanian archipelago off the coast ... coral to create this gentle, velvety body cream to envelop the skin in moisture ...
Breaking Medicine News(10 mins):
(Date:1/23/2017)... InDex Pharmaceuticals Holding AB (publ) today announced ... of the European Crohn,s and Colitis Organisation (ECCO). The ECCO congress ... on inflammatory bowel disease (IBD). The congress is held in ... ... again having been selected to present data at the largest IBD ...
(Date:1/21/2017)... , Jan. 20, 2017 ResMed (NYSE: ... Medical ( Winter Haven, Florida ) today announced they ... parties. BMC and 3B will be permitted to sell their existing ... make a one-time settlement payment to 3B to close the ... did not include an admission of liability or wrongdoing by any ...
(Date:1/21/2017)... 20, 2017 Research and Markets has announced ... Trends - Technology, Route Of Administration, End User - Forecast to ... ... to grow at a CAGR of around 7.8% over the next ... This industry report analyzes the global markets for Advanced Drug Delivery ...
Breaking Medicine Technology: