Anti-inflammatory drug's potentially deadly side effect found to be rare

Scientists have completed an extensive study of more than 3,000 patients who received a promising anti-inflammatory drug, natalizumab, that was linked to three cases of a serious brain infection in large clinical trials halted in early 2005.

The new study found no new cases of progressive multifocal leukoencephalopathy (PML) and confirmed the three previously identified cases of PML associated with use of the drug. One fatal and one nonfatal case of PML occurred in a trial using natalizumab as a multiple sclerosis treatment; a second fatality happened in a trial that used the drug to treat patients with Crohn's disease, an inflammatory bowel disorder.

"Our analysis suggests about one in every1,000 people who took natalizumab contracted this disease; however, there weren't enough patients exposed to the drug to allow us to precisely estimate the risk, which could be as low as one in 5,000 or as high as one in 300," says senior author David Clifford, M.D., the Melba and Forest Seay Professor of Clinical Neuropharmacology in Neurology at Washington University School of Medicine in St. Louis.

The results of the study, along with two separate studies of natalizumab's effectiveness as an MS treatment, are published in this week's issue of The New England Journal of Medicine.

The brand name of natalizumab, which was jointly developed by Biogen and Elan Pharmaceuticals, is Tysabri. The drug is a monoclonal antibody that binds to inflammatory immune T cells and prevents them from crossing membranes that protect the brain and the central nervous system. Prior to the studies that were halted last year, earlier studies showed a 66 percent reduction in the rate of relapses in MS patients treated with the natalizumab, which has to be injected on a monthly basis.

Clifford predicts that his group's report and the other studies of natalizumab will be important elements in "lively" discussions to be held by the Food and Drug Administration reg

Contact: Michael C. Purdy
Washington University School of Medicine

Page: 1 2 3 4

Related medicine news :

1. Anti-inflammatory drug prevents liver cancer in at-risk liver patients
2. Anti-inflammatory drugs following hip replacement surgery could harm rather than help
3. Anti-inflammatory function of Alzheimers disease drugs revealed
4. A drugs brand name skews patient treatment choices
5. Chemical maps hint at drugs effects on schizophrenia
6. Study to test drugs potential to preserve insulin production in newly diagnosed type 1 diabetics
7. Trial demonstrates new drugs effectiveness against psoriasis
8. DNA vaccine against multiple sclerosis appears safe, potentially beneficial
9. STAMP system can help professionals to identify potentially violent individuals
10. Women with breast cancer do not get potentially life-saving information, survey reveals
11. U-M study finds some prostate cancer patients potentially overtreated

Post Your Comments:

(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
(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 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
(Date:6/24/2016)... Vegas, Nevada (PRWEB) , ... June 24, 2016 ... ... Las Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and processing ... Grove, in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of ...
(Date:6/24/2016)... ... June 24, 2016 , ... National recruitment firm Slone Partners is ... sequencing and genomics experience, as Vice President of North American Capital Sales at ... for leading the sales team in the commercialization of the HTG EdgeSeq system and ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... the appointment of Dr. Edward Futcher ... Non-Executive Director, effective June 23, 2016.Dr. Futcher was ... Nominations and Governance Committees.  As a non-executive member ... independent expertise and strategic counsel to VolitionRx in ...
Breaking Medicine Technology:
Cached News: