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:8/1/2015)... , ... August 01, 2015 , ... “ reTXT ” ... at the latest and coolest applications on the market for iOS, Android, and Windows. ... shared with viewers allows users to clarify, edit and delete any message including ones ...
(Date:7/31/2015)... Las Vegas, NV (PRWEB) , ... July 31, 2015 , ... Ticket Down is a ... Las Vegas at the MGM Grand Garden Arena. Fans of every genre of music ... On Friday, September 18th, the first day of the festival, the following artists will perform: ...
(Date:7/31/2015)... CA (PRWEB) , ... August 01, 2015 , ... Super Bowl 50 will ... National Football League’s biggest day each year is the Super Bowl. In the two weeks ... takes place from the host venue. The 2016 Super Bowl game will mark the 50th ...
(Date:7/31/2015)... ... July 31, 2015 , ... Recently touted by ... predictive health analytics , Jvion continues to disrupt the predictive analytic and ... that targets patient and population level illness to drive prevention and better health ...
(Date:7/31/2015)... ... ... Sculpted Contours Luxury Medical Aesthetics announces the arrival of the newest applicator for ... applicator in the United States as an upgrade to the CoolSmooth applicator cleared by ... required a 2 hour treatment time. The new CoolSmooth Pro reduces the treatment ...
Breaking Medicine News(10 mins):Health News:Correct Auto-Correct and Clarify the Unclear with reTXT Messaging App 2Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 2Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 3Health News:Cheap 2016 Super Bowl Tickets at Levi's Stadium: Ticket Down Slashes Ticket Prices on Super Bowl 50 Tickets in Santa Clara, CA at Levi's Stadium 2Health News:Jvion Showcased as Leader in the Predictive Analytic Market 2Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 2Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 3
... of life for patients with chronic rheumatic diseases. ... patient, is// out to improve the way rheumatology ... an hour-long audioconference on April 17, she will ... research, give practical communication tips and share her ...
... nature, in the form of an extract from the bark ... a notorious type of childhood// eye cancer, called retinoblastoma. Retinoblastoma ... about one in 15000 children. ,Usually the cancer ... untreated can be fatal. Dr. Joan O'Brien of the University ...
... Protocol-driven insulin therapy on the medical-surgical wards resulted in ... patients with diabetic foot ulcers. As a result, shorter ... ,“This is the first randomized pilot trial to showcase ... help to improve diabetes control,” Alicia Leung, MD, at ...
... to pay for medical treatment and prescriptions is common ... recovery//, more angina, poorer quality of life and higher ... at Yale School of Medicine. ,The study ... care services or medication were associated with worse patient ...
... diagnosed with aggressive prostate cancer, many men are told that ... best. Often this means patients are told to watch and ... new study has found that either surgical removal of the ... expectancy for these patients when compared with those receiving the ...
... state of Tamilnadu has launched a free nutritional supplement ... Food Programme of the United Nations (UNWFP) would ... scheme called Nutriplus. ,Gian Pietro Bordignon, ... the government of Tamilnadu signed on Friday a memorandum ...
Cached Medicine News:Health News:Destroying Taboos to Improve Patient Care 2Health News:New Research May Pave the Way for Shorter Hospital Stays for Diabetes Patients 2Health News:Due to Cost, Heart Attack Patients Often Avoid Follow-up Care and Medication 2Health News:Surgery, Radiation Treatment Double Life Expectancy for Prostate Cancer Patients 2
(Date:7/31/2015)... SAN DIEGO , July 31, 2015 ... Eisai Co., Ltd. (Headquarters: Tokyo , ... Halozyme Therapeutics, Inc. (Headquarters: San Diego, California ... , "NASDAQ: HALO") have signed a clinical collaboration agreement ... , "eribulin") in combination with Halozyme,s investigational drug PEGPH20 ...
(Date:7/30/2015)... July 30, 2015 Edwards Lifesciences Corporation (NYSE: ... valves and hemodynamic monitoring, today announced that Robert A. ... "Bob is an ardent champion for innovation in ... to have him on Edwards, board as we pursue our ... chairman and CEO.  "Bob has provided a valuable perspective to ...
(Date:7/30/2015)... July 30, 2015  ResMed Inc. (NYSE: RMD ... 30, 2015.  Revenue for the quarter was $453.1 million, ... June 30, 2014 (a 17 percent increase on a ... with the quarter ended June 30, 2014.  Diluted earnings ... the quarter ended June 30, 2014.  ...
Breaking Medicine Technology:Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 2Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 3Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 4Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 5Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 6ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 2ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 3ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 4ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 5ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 6ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 7ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 8ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 9ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 10ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 11ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 12ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 13ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 14ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 15ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 16
... 2011 Researchers presented data demonstrating increased specificity ...  MRI for the detection of breast cancer at ... National Interdisciplinary Breast Center Conference held March 12 ... poster presentation, titled Pre-Surgical Detection of Malignancies ...
... Varian Medical Systems (NYSE: VAR ) announced ... fiscal year 2011 following the close of regular trading on ... by a teleconference available to all interested parties at 2:00 ... conference call webcast will be available on the company website ...
Cached Medicine Technology:Researchers Present Key Findings Comparing PEM to MRI for Identification of Contralateral Breast Cancer at the National Consortium of Breast Centers (NCBC) Conference 2Varian Medical Systems Schedules Second Quarter FY2011 News Release and Conference Call 2
... the only four-color, automated benchtop flow cytometry ... cell sorting. Designed specifically to support a ... offers software instrument control, auto-sample loading, and ... productivity. FACSCalibur is fully modular so it ...
... cytometer especially suited for cell analysis ... CyFlow allows to analyze scatter signals ... fluorescence channels. Data acquisition, analysis, and ... built-in PC employing Partec DPAC software, ...
This unique system combines the analytical power of a research cytometer into a compact, truly walk away, clinical analyzer ergonomically designed to expedite sample throughput....
The Cytomics FC 500 Series delivers flexible testing, powerful software and a user-friendly interface features that help researchers optimize their overall workflow efficiency while maintaining true ...
Medicine Products: