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FDA Safety Panel Reviewing Enbrel Effects On Children

Posted by Jane Akre
Monday, June 16, 2008 5:16 PM EST
Category: Major Medical, Protecting Your Family
Tags: Psoriasis, FDA and Prescription Drugs, Defective Drugs

Enbrel and other TNF blockers are the subject of an advisory panel meeting Wednesday by the FDA.


IMAGE SOURCE: Wikimedia Commons/ psoriasis on palms/ author: Department of Defense 


The drug that has the attention of drug safety reviewers is called Enbrel and it is used to treat psoriasis, and other conditions.

An FDA advisory panel plans to meet Wednesday about the possible life-threatening complications children face when taking the drug, made by Amgen in cooperation with Wyeth. 

The companies would like to include children with moderate forms of psoriasis in their marketing scope. It is already approved for use in children and adults as a treatment for arthritis.

Whether the new use is approved or not, the FDA is considering strengthening the drug’s label to include a warning that its use can lead to death or hospitalizations in children. 

The panel will review entries into the FDA's adverse event reporting database.

In the case of Enbrel, that includes 949 reports of serious complication among children, ages 4 to 17, taking the drug for psoriasis and arthritis.  Five of the psoriasis patients were hospitalized, there were 14 deaths, and 76 cases of complications, among them, malignancies, infections, seizures, and anemia.

"Given that the drug usage in pediatric population is estimated to be fairly small at this time, the numbers and types of post-marketing adverse events reported are concerning," the reviewers wrote.

This class of drugs works by suppressing the immune system, specifically the tumor necrosis factor (TNF) chemical that can lead to inflammation.

The FDA safety panel will also consider seven cases of cancer among children taking Enbrel, to determine if TNF blockers, including rival products made by Johnson & Johnson, and Abbott Laboratories, are linked to cancer.  T

Those drugs include the brand names Remicade, Humira and Cimzia.

The FDA generally follows the recommendations of the advisory panel.

Even if Enbrel is not approved to be prescribed to children for psoriasis, doctors can still do so at their own discretion. 

The FDA is asking manufacturers of the TNF blockers to provide information about cases of cancers among children treated.  Long-term studies will begin next year and will take 10 years to complete.

Amgen and Wyeth tell Reuters they support the FDA review and will provide requested information.  

"At the current time, the FDA believes that the potential benefits of the use of TNF blockers outweigh the potential risks in certain children and young adults," the FDA said in a document on its Web site.

Consumers are being asked to report adverse events related to the drugs by calling 1-800-332-1088 or go to the FDA’s Medwatch Web site to make a report.  #

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