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The draft guidance the FDA issued Wednesday is designed to let drug makers know what kinds of studies to conduct to measure the effectiveness of the new formulations, and how the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The FDA is looking for public comments on the draft guidance, and will make its final recommendations later in the year.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:6/25/2016)... ... ... Bruton Memorial Library on June 21 due to a possible lice infestation, as reported by ... lice: the parasite’s ability to live away from a human host, and to infest common ... the event that lice have simply gotten out of control. , As lice are a ...
(Date:6/25/2016)... ... 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland ... iHire in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness ... & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join ... wage raise to $12 an hour by 2020 and then adjusting it yearly to increase ... of the minimum wage, assure the wage floor does not erode again, and make future ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... actively feeding the Frederick area economy by obtaining investment capital for emerging technology ... past 2½ years that have already resulted in more than a million dollars ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Research and Markets has announced the addition of the ... to their offering. ... World Market for Companion Diagnostics covers the world market for ... report includes the following: , World IVD ... (N. America, EU, ROW), 2015-2020 , World IVD Companion ...
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... , June 23, 2016 ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, ... Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast to ... The global pharmaceutical excipients market ... at a CAGR of 6.1% in the forecast period ...
Breaking Medicine Technology: