Navigation Links
FDA Reverses Stance on Removal of Morphine Painkiller

Appeals from hospice experts mean an unapproved drug, one of 14 given recent warning, will remain on the market, agency says,,,,

THURSDAY, April 9 (HealthDay News) -- Bowing to the pleas of hospice experts, the U.S. Food and Drug Administration has backed off its intent to remove from the market an unapproved liquid morphine painkiller given to dying patients.

Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, told the Associated Press Thursday that the morphine liquid will remain on the market until replaced by an approved version or some other equivalent therapy.

The reversal follows a March 31 FDA warning to nine companies to stop making 14 unapproved prescription narcotic painkillers.

The liquid morphine was one of those painkillers, and is highly concentrated. Throckmorton said health officials had thought that other, more diluted forms of morphine could replace the concentrated one.

But, he told AP, reaction from hospice experts and others "helped us understand" that some patients need the unapproved version.

Dr. Porter Storey, executive vice president of the American Academy of Hospice and Palliative Medicine, called the FDA action "a really important step in the right direction." He added that it showed "an amazing level of responsiveness we're not used to seeing in our government officials," according to AP.

Deborah Autor, director of the Office of Compliance at the FDA Center, told reporters during a March 31 teleconference that the unapproved products posed a risk for consumers. "These include respiratory depression and other serious adverse events, including death," she said.

The batch of warning letters sent at the time was 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, according to the FDA.

"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 told reporters.

Starting in late March, the companies had 60 days to stop manufacturing these products and 90 days to stop distributing them, Autor added. "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 said.

The companies getting warning letters were: 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.

Throckmorton said Thursday that the stop-order for the other painkillers was still in place.

More information

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

SOURCES: Associated Press; 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. Combination therapy reverses effects of portal hypertension in rats
2. Gene Tweak Reverses Aging in Mouse Skin Cells
3. Gene therapy trains immune system to destroy brain cancer cells and reverses behavioral deficits
4. Court of Appeals Reverses Lower Court Decision in Favor of TriMed, Inc. Patent Infringement Case
5. Drug therapy for PKU reverses heart damage
6. Scripps Research scientists find seizure drug reverses cellular effects
7. New vaccine approach prevents/reverses diabetes in lab study at Childrens Hospital of Pittsburgh
8. HiCy drug regimen reverses ms symptoms in selected patients
9. Compound Reverses Huntingtons Symptoms in Mice
10. By shutting down inflammation, agent reverses damage from spinal cord injury in preclinical studies
11. Fat on chest and upper back increases risk of insulin resistance
Post Your Comments:
Related Image:
FDA Reverses Stance on Removal of Morphine Painkiller 
(Date:6/27/2016)... Viejo, California (PRWEB) , ... June 27, 2016 , ... ... are fully customizable inside of Final Cut Pro X," said Christina Austin - CEO ... another unique style. Final Cut Pro X users can now reveal the ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... its strategic partnership with Connance, a healthcare industry leader providing predictive analytics ... proprietary technology combine to provide health systems, hospitals and ambulatory surgical centers ...
(Date:6/27/2016)... , ... June 27, 2016 , ... recently awarded ... Eyeglasses . , Millions of individuals in the United States and Canada wear ... a way to both correct vision and make a fashion statement. Even celebrities use ...
(Date:6/26/2016)... Battle Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... abuse, joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table ... held in honor of the city’s history as home to some of the world’s ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned ... developed to enhance the health of felines. The formula is all-natural and is made ... in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 23, 2016 Research and Markets has ... - Forecast to 2022" report to their offering. ... for the patients with kidney failure, it replaces the function ... the patient,s blood and thus the treatment helps to keep ... in balance. Increasing number of ESRD patients ...
(Date:6/23/2016)... -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that ... PCT (procalcitonin) assay as a dedicated testing solution for ... clearance, Roche is the first IVD company in the ... risk assessment and management. PCT is a ... in blood can aid clinicians in assessing the risk ...
(Date:6/23/2016)... WAYNE, Pa. , June 23, 2016 ... provider, will launch its next generation clinical outcomes platform, Bracket ... DIA Meeting held on June 26 – 30, 2016 in ... 6.0, the first electronic Clinical Outcome Assessment product of its ... DIA Booth #715. Bracket eCOA 6.0 is a ...
Breaking Medicine Technology: