FDA Staff Wants Amgen To Add Stronger Warning About Enbrel Side Effects In Children

June 2008 Staff Report Cites Cancers, Infections, And Neurological Problems Similar To Serious Side Effects In Adults

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 16, 2008 the FDA released a staff report, "Enbrel (etanercept) for the Treatment of Pediatric Plaque Psoriasis", which was prepared for the Dermatologic and Ophthalmic Drugs Advisory Committee's June 18, 2008 meeting.

In part, that FDA advisory committee will consider whether or not Amgen Inc. -- which markets Enbrel with Wyeth -- should be permitted to promote Enbrel for use by children with moderate to severe forms of the skin condition psoriasis.  At present, Enbrel is prescribed to treat psoriasis in children on an "off-label" basis, which means that the FDA has not approved Enbrel for that type of use but doctors are allowed to prescribe it to children with psoriasis when using their medical judgment.

According to a June 16, 2008 Reuters article, "UPDATE 2-Amgen's Enbrel in kids 'concerning'-FDA staff", by reporter Susan Heavey:

Regardless of whether the regulators approve the new use, FDA staff reviewers recommended the agency strengthen the drug's label to include reports of serious side effects in children that could lead to deaths or hospitalizations....

FDA safety reviewers looked at 949 reports of serious complications in children ages 4 to 17 taking Enbrel, or etanercept, for psoriasis as well as arthritis.

Among them, 61 reports were for psoriasis patients, according to the documents. No deaths were reported, but five patients were hospitalized.

Overall, the FDA found 14 deaths and 76 other life-threatening cases. Complications included serious infections as well as 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.

The FDA staff who prepared this June 2008 report will present their findings to the Dermatologic and Ophthalmic Drugs Advisory Committee which, in turn, will make a recommendation to the FDA about whether or not Enbrel should be approved for the treatment of psoriasis in children.

As we reported recently, the FDA also is investigating whether Enbrel, along with rival products Johnson & Johnson's Remicade and Abbott Laboratories Inc's Humira, are linked to cancer in children.

According to the June 16 Reuters news article:

FDA reviewers found seven cases of cancer in children taking Enbrel, and two cases were reported in an Amgen study, according to the documents released on Monday.

We will watch for the advisory panel's recommendation about whether Enbrel should be used for pediatric psoriasis and for developments in the FDA's investigation about whether Enbrel, Humira, and/or Remicade are linked to cancer in children.