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."

Authorities also looked at one reported case of histoplasmosis in a patient taking Cimzia. There have also been reports of other fungal infections, notably coccidioidomycosis and blastomycosis, some fatal, in patients taking these drugs.

The FDA is already in the middle of a safety review of TNF blockers, including an investigation into whether or not the drugs are linked with the development of cancer, particularly lymphoma, in children and young adults. "We have a six-month timeline for that review, and we intend to meet that timeline," Siegel said.

All the drug labels already include information about possible fungal infections, but authorities expressed concern that the issue wasn't highlighted appropriately.

"We've been concerned about the possibility of serious infectious since we initially approved these drugs, and it has been in the labeling since the beginning," Siegel said. "Warnings about serious infections have included fungal infections. What's new is that we became aware that some physicians may not be considering the possibility of fungal infections early enough, so we want to raise awareness. So far, companies have been fully cooperating with efforts here."

"We don't want to give the impression that these conditions were neglected," Siegel continued. "They're hard to diagnose, and they can mimic other conditions. We think the new message is that people weren't aware that this might happen but that it is under-diagnosed and important to identify."

The manufacturers are required to submit labeling changes within 30 days or to outline reasons as to why labeling changes are not necessary.

Doctors and patients should be on the lookout for persistent fever, cough, shortness of breath and fatigue. Any patients experiencing these symptoms, especially if they live or have traveled to areas where the fungus is endemic, should seek medical attention immediately.

"What we're trying to do here is help patients own their own health care, and our advice is don't hesitate to contact their doctor if they feel any of these key symptoms related to these kinds of infections," Siegel said.

More information

The FDA has more on TNF blockers.



SOURCES: Sept. 4, 2008, teleconference with Jeffrey Siegel, M.D., clinical team leader, Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

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:8/20/2017)... Centennial, CO (PRWEB) , ... August 20, 2017 , ... ... in the same household? If so, you may be interested in participating in ... The purpose of this research is to understand more about the relational aspects of ...
(Date:8/19/2017)... York, New York (PRWEB) , ... August 19, ... ... Street Health has announced that it is the first organization with pending recognition ... CDC’s National Diabetes Prevention Program (“DPP”) via group telehealth classes and live video ...
(Date:8/19/2017)... ... August 19, 2017 , ... Physician Partners ... Orlando location as an interventional pain management physician. He brings a wealth of ... of migraine headaches, and significant experience in spinal cord stimulation for chronic pain. ...
(Date:8/18/2017)... ... August 18, 2017 , ... ... specialized asset-light logistics provider of complex transport solutions for mission-critical and non-discretionary ... Unitrans International Corporation, a division of Roadrunner Transportation Systems, Inc. (NYSE: RRTS). ...
(Date:8/18/2017)... ... ... The Dawn Johnson Insurance Group, a Missouri-based insurance and financial planning firm ... for efforts to educate the local population on cancer realities while attracting donations to ... , Each day in America, roughly 4,600 new cases of cancer are diagnosed and ...
Breaking Medicine News(10 mins):
(Date:7/28/2017)... July 28, 2017 Hill-Rom Holdings, Inc. ("Hill-Rom") ... third quarter ended June 30, 2017, and updated its ... For the fiscal third quarter, Hill-Rom ... $0.68 per diluted share in the prior-year period. These ... $0.39 per diluted share primarily related to the non-cash ...
(Date:7/27/2017)... July 27, 2017  West Pharmaceutical Services, Inc. (NYSE: ... for the second-quarter 2017 and updated financial guidance for ... Second-Quarter 2017 Highlights Reported net sales ... the prior-year quarter. Net sales at constant currency (organic) ... EPS was $0.51, compared to $0.60 in the prior-year ...
(Date:7/26/2017)... , July 26, 2017 Sancilio Pharmaceuticals ... of our clinical trial evaluating Altemia TM , an ... (SCA) and Sickle Cell Disease (SCD). The SCOT Trial, ... the efficacy and safety of Altemia TM in ... conducted under US IND 125274. ...
Breaking Medicine Technology: