Navigation Links
FDA Warns Drug Makers to Stop Selling Unapproved Prescription Painkillers
Date:3/31/2009

Action should not affect consumers or lead to shortages, the agency says,,,,

TUESDAY, March 31 (HealthDay News) -- The U.S. Food and Drug Administration on Tuesday warned nine companies to stop making 14 unapproved prescription narcotic painkillers.

These unapproved products pose a risk for consumers, Deborah Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, said during a morning teleconference. "These include respiratory depression and other serious adverse events, including death," she said.

The action is part of an ongoing effort to remove unapproved medicines from the market; roughly 2 percent of all prescriptions in the United States are filled with unapproved drugs, the FDA said.

This latest batch of warning letters tells the companies they could face enforcement action if they do not stop making and selling these unapproved drugs, including high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. Oxycodone capsules and approved tablets are not included in this warning, the agency noted.

"The FDA wants to assure consumers who rely on these products for pain relief that they will still have access to FDA-approved narcotic drugs and there will be no shortage for consumers," Autor said.

The companies have 60 days to stop manufacturing these products and 90 days to stop distributing them, Autor said. "FDA expects all manufacturers and distributors of unapproved versions of these products to honor these deadlines and will not tolerate any manufacture or distribution after these deadlines," she added.

The companies getting warning letters are: Boehringer Ingelheim Roxane Inc., of Columbus, Ohio; Cody Laboratories Inc., Cody, Wyo.; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Co., Philadelphia; Lehigh Valley Technologies Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.

The market share of these unapproved pain products varies from product to product. One product slated to be removed from the market has about a 4 percent market share, while another unapproved product represents about 53 percent of the market, Autor said.

"Today's action is about ensuring that Americans have safe and effective drugs and getting the message to companies that they have a responsibility to patients that they should actively pursue FDA approval for their illegally marketed products," Autor said.

The FDA's pursuit of unapproved drugs began in 2006, and to date the agency's action has taken more than 500 unapproved drugs off the market from over 200 drug companies, Autor said. There are still several thousand unapproved drugs on the market, she added.

More information

For more on unapproved drugs, visit the U.S. Food and Drug Administration.



SOURCES: March 31, 2009, teleconference with Deborah Autor, J.D., director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.


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

Related medicine news :

1. FDA Warns of Codeine Risk for Some Nursing Mothers
2. PA Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Perry County Dairy
3. Research warns that human papillomavirus might cause bladder cancer
4. New research warns of the lack of specialization when judging individuals with mental disorders
5. Coalition of Caregivers Warns Congress of Danger to Oldest U.S. Seniors if Medicare Slashed
6. Health Department Warns Consumers of Home-Canned Soup Linked to Potter County Restaurant
7. FDA Warns Against Bio-Identical Hormone Therapy
8. Cold Meds Not Safe for Kids Under 2, FDA Warns
9. FDA Warns Clot Risk Higher in Birth Control Patch Than Pill
10. Renaissance Health Publishing, LLC Warns the Public that ConsumerLab.com is Not Independent and Labels the CL Seal of Approval a Worthless, Paid-For Advertising Gimmick
11. Health Capital Group Warns of Fallout to Hospitals From the Subprime Mortgage Crisis and Urges Hospitals to Immediately Reassess Existing Debt Structures and Capital Financing Plans
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Warns Drug Makers to Stop Selling Unapproved Prescription Painkillers
(Date:8/18/2017)... , ... August 18, 2017 , ... ... & Hearing” campaign, advocating for active, healthy lifestyles and highlighting the importance of ... individuals with hearing impairments and shares the latest innovations in hearing aid technology. ...
(Date:8/18/2017)... (PRWEB) , ... August 18, 2017 , ... ... and financial planning services to communities in east Texas, is launching a regional ... Tumor Foundation. , Founded in 1991, the Pediatric Brain Tumor Foundation (PBTF) has ...
(Date:8/18/2017)... Missouri (PRWEB) , ... August 18, 2017 , ... “Emotions ... Suzanne Tucker, Founder of St. Louis-based positive education company Generation Mindful. To help change ... help children learn social and emotional skills, she created the Time-In Toolkit, which launched ...
(Date:8/18/2017)... ... August 18, 2017 , ... ... tracking and monitoring solutions, announced today the launch of a redesigned corporate website, ... navigation and aesthetic, fully responsive design, and an enhanced search directory for businesses ...
(Date:8/18/2017)... ... , ... “Depressed: Super Heroes of the Bible”: a gripping and potent ... the relevance these tales may have on the reader’s life. “Depressed: Super Heroes of ... teacher, Jessica spends much of her time enjoying nature and her family in West ...
Breaking Medicine News(10 mins):
(Date:7/31/2017)... July 31, 2017 7D Surgical, developer of ground ... purchased the 7D Surgical System to support its strategic sales ... D.C. and Virginia.  7D Surgical has entered into ... of the premier medical facilities within those markets. ... ...
(Date:7/28/2017)... --EnvoyHealth, a Diplomat company, has partnered with Compliance Meds ... a technology designed to improve patient medication adherence. ... solutions and services that help track and improve patients, ... LITE offers medication monitoring and control for patients and ... Records date and time of bottle ...
(Date:7/27/2017)... 2017  West Pharmaceutical Services, Inc. (NYSE: ... second-quarter 2017 and updated financial guidance for the full-year ... Highlights Reported net sales of $397.6 ... quarter. Net sales at constant currency (organic) grew by ... $0.51, compared to $0.60 in the prior-year quarter. Second-quarter ...
Breaking Medicine Technology: