Navigation Links
Makers of Powerful Painkillers Present Safety Plans
Date:12/4/2009

Move a response to pressure from federal regulators to crack down on abuse of opioid medications

FRIDAY, Dec. 4 (HealthDay News) -- The makers of 24 different prescription painkillers on Friday presented federal regulators with plans to curb the abuse of these opioid drugs.

The pharmaceutical companies have been under pressure from U.S. Food and Drug Administration officials to find a way to stop the hundreds of fatal overdoses that occur with these medications each year, the Associated Press reported.

Executives from Johnson & Johnson, King Pharmaceuticals and other drug makers proposed using patient medication guides, letters to doctors and additional physician training to end the misuse and inappropriate prescribing of painkillers, according to the wire service.

In February, FDA officials sent letters to 16 companies ordering them to design risk-management plans for their drugs. The drug makers presented their joint proposal to the agency after several months of discussion.

The painkillers in question include morphine, oxycodone and methadone.

This marks the first time the agency has required a risk-management plan for an entire class of drugs, the AP reported.

However, the problem is significant: a 2007 survey found 5.2 million people in the United States reported using prescription painkillers inappropriately.

Such drugs are typically approved for people requiring round-the-clock treatment for moderate to severe chronic pain, such as cancer patients.

But, significant harm can occur if patients are uninformed about how to properly take the drugs, doctors inappropriately prescribe the drugs, or if legitimate prescriptions get into the hands of people other than the intended patient, Dr. John Jenkins, director of the FDA's Office of New Drugs, part of the Center for Drug Evaluation and Research, said during a news conference back in February.

Jenkins said then that the agency was taking this step to implement "a relatively massive new program," because "the rates of misuse and abuse [of opiates] have risen over the past decade." He also said the FDA was better able to address the problem, because the Food and Drug Administration Amendments Act of 2007 gave the agency the authority to regulate opioids.

This is "our attempt to try and ensure that the benefits of the products outweigh their risks," Jenkins said in February.

In addition to patient misuse, the FDA has documented many cases of physicians prescribing the potent painkillers for people with migraines, an unapproved use. The FDA said patients also sometimes chew extended-release pills that are designed to be swallowed, causing an accidental overdose of the drug.

More information

To learn more about pain control and pain medications, visit the American Academy of Family Physicians.



SOURCES: February 2009 teleconference with John Jenkins, M.D., director of the Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Associated Press


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Consumer Watchdog Hails House Cost-Control Plan to Regulate Health Insurance Rates, Urges Lawmakers to Combine It With Strong Public Option
2. Patients who received donated pacemakers survive without complications
3. Boston Biotech R&D Conference to Showcase Next-Generation Newsmakers and Massachusetts as Leader in Biotech Discovery
4. Makers of Trojan(R) Brand Condoms Introduce Trojan 2GO(R), a Unique, Portable, Protective and Discreet Packaging for Condoms
5. Photos: The Makers of LISTERINE(R) and REACH(R) TOTAL CARE Products Unveil a New Laugh-Out-Loud Book Benefiting the National Childrens Oral Health Foundation(R): Americas Toothfairy
6. For Medical Device Makers, Free Webinar, Implementing QA Automation.
7. Cell Therapeutics, Inc.s (CTI) Presentation at BioCentury NewsMakers Conference to be Webcast
8. PDL BioPharma to Present at BioCentury Newsmakers Conference on September 16, 2009
9. Policy Makers Discuss Health Care Reform at URAC Quality Summit
10. Tevas Patient First Initiative Highlights Struggle Against High Health Care Costs, Reminds Lawmakers of Reform Goals
11. Hagens Berman Sobol Shapiro: Vytorin and Zetia Makers Settle Class-Action Suit With Proposed $41.5 Million
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 2017 , ... Apple Rehab Shelton Lakes , which specializes in the ... facility as part of a disaster drill on October 3rd. , Apple Rehab participated ... Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid Plan ...
(Date:10/13/2017)... ... ... The Visiting Nurse Association (VNA) of Somerset Hills is proud to host ... items from across the nation, this holiday-themed event will raise funds and awareness for ... The boutique will be open Saturday, November 4 (10:00 a.m. – 5:00 p.m.) ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids ... Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, ... run is geared towards children of all ages; it is a non-competitive, non-timed event, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor ... on sciatica in a new episode of "Success Files," which is an award-winning ... innovation and investigates each subject in-depth with passion and integrity. , Sciatica occurs ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of ... Philippines. “The Journey: From the Mountains to the Mission Field” is the creation of ... taught all ages and currently teaches a class of ladies at her church, which ...
Breaking Medicine News(10 mins):
(Date:9/13/2017)... OrthoAtlanta has been named the official orthopedic and sports ... the 2018 College Football Playoff (CFP) National Championship to be ... Atlanta, Georgia . OrthoAtlanta is proud to ... in many activities leading up to, and including the national ... OrthoAtlanta ...
(Date:9/12/2017)... -- Consumer reviews on the independent review site Consumer Affairs ... for hearing aids, ranking it higher than Miracle Ear ™, ... ... Hearing Aids ... store that provides high performance, state-of-the-art, German-engineered hearing aids directly to ...
(Date:9/9/2017)... 8, 2017 ... Unit coming to Washington DC ... When: Tuesday, September 12 th – Monday, September 18 th .The ... free MRI brain scans to the public.Where:  BTF,s ... at 501 K Street NW, Washington, D.C.What:BTF brings its nationwide initiative, the ...
Breaking Medicine Technology: