OT: Warning From F.D.A. on Arthritis Drugs for Young Patients

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The drugs are prescribed to children with rheumatoid arthritis, inflammatory

bowel disorder and Crohns disease.

Warning From F.D.A. on Arthritis Drugs for Young Patients

http://www.nytimes.com/2009/08/05/health/05DRUG.html?ref=health

 

By THE ASSOCIATED PRESS

August 5, 2009

WASHINGTON (AP) Federal regulators on Tuesday added stronger warnings to a group

of best-selling drugs used to treat arthritis and other inflammatory diseases,

saying they can increase the risk of cancer in children and adolescents.

After more than a year of review, Food and Drug Administration scientists said

the drugs appeared to increase the risk of cancer after they were used for more

than two and a half years.

The agency studied several dozen reports of cancer, some fatal, in children

taking the drugs. Half of the cases were lymphomas, a cancer that attacks the

immune system.

The drugs are known as tumor necrosis factor blockers and work by neutralizing a

protein that, when overproduced, causes inflammation and damage to bones,

cartilage and other tissue. The drugs are prescribed to children with rheumatoid

arthritis, inflammatory bowel disorder and Crohn’s disease.

The drug agency will bolster the black box warning on the five drugs sold in the

United States, including Abbott Laboratories Humira, & Remicade

and Simponi, and Enbrel, which is marketed by Amgen and Wyeth. All the products

are multibillion- dollar sellers. Enbrel was the biggest moneymaker of the

group, with sales in the United States of $3.4 billion last year.

The action also affects Cimzia, which was introduced in May by the Belgian drug

maker UCB.

Along with updating the drugs labels, the F.D.A. is requiring companies to add

information about cancer risks to the medication guides given to patients. The

agency said it was also working with the manufacturers to further define the

scope of the cancer risk.

& said in a statement that it would coordinate closely with the

F.D.A. to ensure that health care providers, patients and caregivers are

properly informed.

Amgen and Wyeth said they would continue working with regulators to evaluate the

potential risks and benefits of their drug.