Navigation Links
FDA Demands Tougher Warnings on Immunosuppressive Drugs
Date:9/4/2008

Officials want stronger labeling about fungal infection risk

THURSDAY, Sept. 4 (HealthDay News) -- Federal health authorities have asked the manufacturers of four widely used immunosuppressive drugs to bolster safety warnings on the risk of developing opportunistic fungal infections.

The drugs, Humira, Cimzia, Enbrel and Remicade, belong to a class of medications known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system and are approved to treat several conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and Crohn's disease.

All four drugs already carry black-box warnings related to different safety issues, including fungal infections.

"FDA has asked the manufacturers of these four drug products to highlight existing warnings of fungal infections," Dr. Jeffrey Siegel, clinical team leader in the division of anesthesia, analgesia and rheumatology products at the FDA's Center for Drug Evaluation and Research, said at a Thursday news conference. "The box warning, which is the most serious warning in the labeling, must be upgraded to strongly warn doctors to consider the occurrence of histoplasmosis and other fungal infections."

Histoplasmosis is caused by the fungus Histoplasma capsulatum and can cause flu-like symptoms. The FDA reviewed 240 reports of histoplasmosis in patients taking Enbrel, Humira or Remicade, most of whom reside in the Ohio River and Mississippi River valleys, where the fungus is endemic.

Twenty-one of these patients had delayed diagnoses and therefore delayed treatment. Of these, 12 died. Overall, among the 240 patients reviewed, 45 died.

"These infections need to be identified early enough so that treatment is not delayed," Siegel said. "In a number of cases, treatment was delayed and resulted in prolonged hospitalization and death.
'/>"/>

Copyright©2008 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Tx Xchange Launches Web-Based Solution for Physical Therapy and Rehabilitation Providers to Address Demands of Healthcare Consumerism
2. Thompson Demands Solution to Formaldehyde Trailer Crisis
3. Agingcare.com Launches to Meet Information and Networking Demands for Booming 34 Million Caregiver Market
4. DuPont Focused on Meeting Global Demands for Greater Safety & Protection
5. Nucletron Announces Management Buy-Out to More Effectively Meet the Demands of Its Customers and the Radiation Therapy Community
6. Consumers Offer to Pay More to Satisfy Health Demands
7. Minorities, Poor Have Tougher Time Monitoring Diabetes
8. FDA Panel Backs Tougher Warning on Asthma Drugs for Kids
9. FDA Panel Backs Tougher Warning for Tamiflu
10. FDA Mulls Tougher Warning Label on Kids Flu Drugs
11. Blood Pressure Tougher to Tame in Winter
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Demands Tougher Warnings on Immunosuppressive Drugs
(Date:7/13/2014)... Max International has recently ... be the featured guest at its Charity Exhibition and ... Attendees will learn about Max’s health products and ... basketball games and perform in a 3 point shoot-out. ... and energy-boosting supplements , has recently announced former NBA ...
(Date:7/13/2014)... 13, 2014 Epidemiologists forecast an increase ... 6MM, from 8,062 diagnosed incident cases in 2013 to ... Growth Rate (AGR) of 4.35%, during the forecast period. ... of diagnosed incident cases of aGVHD in the 6MM, ... the lowest number of diagnosed incident cases of aGVHD, ...
(Date:7/13/2014)... Seattle, WA (PRWEB) July 13, 2014 According ... Vkool.com, this is a step by step guide on what ... impairment easily and quickly. Vkool writes in its review ... what foods to eat to revitalize their kidney health. Vkool ... book can help people reverse their damaged kidney functions naturally. ...
(Date:7/13/2014)... 2014 Celebrity fitness trainer and former ... promotional partnership with Aqua Health Labs for their flagship ... supplement . The collaboration was recently announced live on ... trainer , actor, model, and a two time World ... celebrities, he has prepared stars including Demi Moore, Hilary ...
(Date:7/13/2014)... Arbor, MI (PRWEB) July 13, 2014 If ... learning program he has just launched at http://www.HealthYourself101.com ... of visceral obesity. , Power has set out to ... its ill effects that’s actually – dare we say it? ... “The program,” says Power, “aims to engage the remote learner ...
Breaking Medicine News(10 mins):Health News:Max International Announces NBA Dream Team Member Chris Mullin as Featured Guest of Charity Event 2Health News:Max International Announces NBA Dream Team Member Chris Mullin as Featured Guest of Charity Event 3Health News:Max International Announces NBA Dream Team Member Chris Mullin as Featured Guest of Charity Event 4Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 2Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 3Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 4Health News:Kidney Disease Solution Book Review Exposes Duncan Capicchiano's Newly Updated Kidney Disease Treatment Plan – Vkool.com 2Health News:Kidney Disease Solution Book Review Exposes Duncan Capicchiano's Newly Updated Kidney Disease Treatment Plan – Vkool.com 3Health News:Celebrity Fitness Expert Supports Revolutionary New Health Supplement 2Health News:Retired Ann Arbor Physician and Professor Wields New Media to Teach Health Science 2Health News:Retired Ann Arbor Physician and Professor Wields New Media to Teach Health Science 3Health News:Retired Ann Arbor Physician and Professor Wields New Media to Teach Health Science 4
... in pediatric study , MONDAY, June 21 (HealthDay News) -- ... who later receive cochlear implants, a new study finds. , ... 3.2 years) who received ear tubes before cochlear implants. In ... removed before cochlear implantation surgery. In all the other cases, ...
... likely to develop allergies, asthma, study suggests , ... born vaginally pick up different bacteria than those who ... immune systems develop, a new study suggests. , ... born through cesarean sections appear to be more at ...
... of an ancient language provides new insights into the ... world. The study, "Dvandvas, Blocking, and the Associative: The ... in the June 2010 issue of the scholarly journal ... Stanford University. A preprint version is available on line ...
... environmental levels of the industrial chemical bisphenol A, or BPA, ... to testicular function, according to a new study conducted in ... Society,s 92nd Annual Meeting in San Diego. "We are ... to BPA levels that are lower than what the Food ...
... The recent revelation that the chair of the ... a tobacco executive until April 2010 sends an unfortunate ... longer a priority, states an editorial http://www.cmaj.ca/cgi/doi/10.1503/cmaj.100850 ... "There is simply no place for the tobacco industry ...
... ... behind the website. , ... June 21, 2010 -- The Active Search Results Search Engine ( www.activesearchresults.com ) announced today ... , , ,ASR Ranking allows search engines to rank search results higher for websites ...
Cached Medicine News:Health News:Ear Tubes Appear to Be Safe Before Cochlear Implantation 2Health News:Delivery Method May Determine the Bacteria Babies Acquire 2Health News:Delivery Method May Determine the Bacteria Babies Acquire 3Health News:The 'bumpy ride' of linguistic change 2Health News:Early-life exposure to BPA may affect testis function in adulthood 2Health News:CMAJ calls for resignation of IDRC chair Barbara McDougall 2Health News:Active Search Results Announces its New Search Engine Ranking Algorithm 2Health News:Active Search Results Announces its New Search Engine Ranking Algorithm 3
(Date:7/11/2014)... -- Neurelis, Inc. ("Neurelis") today announced an agreement with ... by Biotie to purchase Neurelis, clearing the way for ... for pediatric and adult epilepsy patients who experience acute ... has advanced the development program for NRL-1 and worked ... required for NDA submission to the FDA.  Given the ...
(Date:7/10/2014)... , 11. Juli 2014 /PRNewswire/ ... Kameras für die molekulare Bildgebung, einschließlich ... heute die CE-Zulassung für sein Navigator ... kann Dilon das Produkt jetzt europaweit ... den Großteil der europäischen Länder ausgedehnt ...
(Date:7/10/2014)... 2014  Breg, Inc., a premier provider of ... FreeRunner™ knee brace with new innovations to help ... return to active lifestyles.  FreeRunner,s patent-pending design acts ... support when patients need it most, and the ... Patellofemoral issues are the most common cause ...
Breaking Medicine Technology:Neurelis Regains Rights to Intranasal Diazepam Program 2Neurelis Regains Rights to Intranasal Diazepam Program 3Dilon erhält CE-Zulassung für sein Navigator-Gamma-Sondensystem 2Breg Introduces Knee Brace to Help Runners with Patellofemoral Pain Syndrome 2
... Switzerland, Sept. 26, 2011 ... products manufacturers in the world, has launched an international ... of wilate® (von Willebrand Factor/Factor VIII Concentrate, ... pediatric and adult patients with Type 3 von Willebrand ...
... Vermillion, Inc. (NASDAQ: VRML ) a molecular ... Ph.D. as Chief Scientific Officer and Vice President Research ... of Vermillion,s two pipeline products, OVA2™ and VASCLIR®. Specifically, ... clinical studies for registration of these products. As part ...
Cached Medicine Technology:Octapharma Launches Clinical Trial to Evaluate Efficacy & Safety of wilate® In Preventing Surgical Bleeding in Type 3 von Willebrand Disease Patients 2Octapharma Launches Clinical Trial to Evaluate Efficacy & Safety of wilate® In Preventing Surgical Bleeding in Type 3 von Willebrand Disease Patients 3Vermillion Enhances Management Team With A Key Addition 2Vermillion Enhances Management Team With A Key Addition 3Vermillion Enhances Management Team With A Key Addition 4
Extremely wide blade opening. Excellent bio and MRI compatibility. Lot number on each clip. Long reliable history. Large type 1/1 (mm), opening width 8.0 mm and length 10 mm....
Extremely wide blade opening. Excellent bio and MRI compatibility. Lot number on each clip. Long reliable history. Large type 1/1 (mm), opening width 6.0 mm and length 10 mm....
Extremely wide blade opening. Excellent bio and MRI compatibility. Lot number on each clip. Long reliable history. Large type 1/1 (mm), opening width 8.0 mm and length 7.5 mm....
Extremely wide blade opening. Excellent bio and MRI compatibility. Lot number on each clip. Long reliable history. Large type 1/1 (mm), opening width 13.0 mm and length 12 mm....
Medicine Products: