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FDA: Remicade Users May Suffer Blood Disorders

People who use the drug Remicade for rheumatoid arthritis may be at increased risk of a serious blood disorder, the U.S. Food and Drug Administration warned.

The drug's maker, a & subsidiary called Centocor, has 580 reports of adverse reactions, a company spokesperson told the Associated Press. Forty-four of those reports involved a serious blood disorder, and included 12 patients who ultimately died, the wire service account said.

But an FDA spokeswoman said "It was unclear whether these deaths were caused by this product."

The Pennsylvania company has revised its product label and sent a warning to doctors, advising that some patients have suffered reductions in blood cell and platelet counts, making them more vulnerable to infections and abnormal bleeding, the AP reported. In rare cases, users contracted central nervous system problems that led to decaying blood vessels, according to the wire service.

The company is warning doctors to be cautious when prescribing the drug to people with a history of blood problems. It's also warning that Remicade users who have persistent fevers should seek immediate medical care, the AP said.

Copyright © 2004 ScoutNews, LLC. All rights reserved.

Last updated 8/25/2004.

This article can be accessed directly at:http://drkoop.com/template.asp?page=newsDetail & ap=93 & id=1504744

From: mncnotenuftime@... Sent: Wednesday, August 25, 2004 9:37 AMTo: Stillsdisease Subject: FDA Warning

My Husband told me he seen something on the news last night about the FDA sending a warning out for the use of Remicade. Has anyone seen this? I am going to investigate it today......Carey

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Hi Carey:

Yes, it was in the newspaper this morning but it must have been out for a couple of days because the paper down here that we call the mullet (fish) wrapper is usually about three days late! Let me see if I can print the entire article.

"FDA issues Remicade warning

by Diedtra

Washington

The Food and Drug Administration and Manufacturer Centocor are warning Doctors that patients receiving the drug Remicade to treat arthritis and Crohn's disease have suffered sometimes fatal blood and central nervous system disorders.

Centocor, a subsidiary of health-care product manufacturer & said the FDA has been told of 580 adverse reaction reports among 509,000 worldwide patients, said Craig Buchholz, a Centocor spokesman. Fortyfour reports were were most worrisome because they involved significant blood disorders.

At least 12 patients taking Remicade -- in combination with other drugs -- died worldwide.

The Malvern, PA.-based company, working with the federal drug regulatory agency, revised its label for the monoclonal antibody.

The company's Aug. 11 warning letter to doctors said patients receiving Remicade suffered reductions in their red and white blood cell, granulocyte and platelet counts, leaving them more vulnerable to abnormal bleeding and infections. In rare instances, patients suffered central nervous system disorders, including confusing immune system responses that swelled, then decayed, blood vessels."

WE WILL WIN

Love Y'all

"NEVER FIGHT FAIR"

Panama City, FL

Please visit the International Stills Disease Foundation Inc. Web Site at

www.stillsdisease.org

There is now a Third Political Party: The "VPA", Veterans Party of America.

Veterans= "Third Class Citizens"

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Everyone,

Thank you for the info on the Remicade as I have a friend that uses it for the treatment of her chrons disease.

Traci

Tracilyn Brown

Southern land

-----Original Message-----From: Bob Himes Sent: Wednesday, August 25, 2004 3:09 PMTo: Stillsdisease Subject: Re: FDA Warning

Hi Carey:

Yes, it was in the newspaper this morning but it must have been out for a couple of days because the paper down here that we call the mullet (fish) wrapper is usually about three days late! Let me see if I can print the entire article.

"FDA issues Remicade warning

by Diedtra

Washington

The Food and Drug Administration and Manufacturer Centocor are warning Doctors that patients receiving the drug Remicade to treat arthritis and Crohn's disease have suffered sometimes fatal blood and central nervous system disorders.

Centocor, a subsidiary of health-care product manufacturer & said the FDA has been told of 580 adverse reaction reports among 509,000 worldwide patients, said Craig Buchholz, a Centocor spokesman. Fortyfour reports were were most worrisome because they involved significant blood disorders.

At least 12 patients taking Remicade -- in combination with other drugs -- died worldwide.

The Malvern, PA.-based company, working with the federal drug regulatory agency, revised its label for the monoclonal antibody.

The company's Aug. 11 warning letter to doctors said patients receiving Remicade suffered reductions in their red and white blood cell, granulocyte and platelet counts, leaving them more vulnerable to abnormal bleeding and infections. In rare instances, patients suffered central nervous system disorders, including confusing immune system responses that swelled, then decayed, blood vessels."

WE WILL WIN

Love Y'all

"NEVER FIGHT FAIR"

Panama City, FL

Please visit the International Stills Disease Foundation Inc. Web Site at

www.stillsdisease.org

There is now a Third Political Party: The "VPA", Veterans Party of America.

Veterans= "Third Class Citizens"

Visit the Still's Disease Message Boardhttp://disc.server.com/Indices/148599.htmlThe materials and information contained in this message are not intended to replace the services of a trained health professional or to be a substitute for medical advice of physicians and/or other health care professionals. The International Still's Disease Foundation is not engaged in rendering medical or professional medical services. You should consult your physician on specific medical questions, particularly in matters requiring diagnosis or medical attention. The International Still's Disease Foundation makes no representations or warranties with respect to any treatment, action, application, medication or preparation by any person following the information offered or provided within this support form. ion by any person following the information offered or provided within this support form.

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