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Subscribe To Our Syndicated NewsWarnings Added to Amgen Label's
-June 16, 2008
The FDA recently announced that it wants to increase the level of awareness on the warnings label’s for Enbrel.
Enbrel is a product of Amgen Inc., and is commonly prescribed to treat rheumatoid arthritis in children and adults, as well as adults with psoriasis.
Risks Found with Medication
According to research, Enbrel can lead to moderate and severe infections in patients and can even result in death in certain cases.
Despite these findings, Amgen is seeking to get FDA approval for the drug to treat children with psoriasis.
The FDA is reportedly meeting this week to discuss this proposal.
“Given these considerable risks associated with Enbrel, the benefit of this therapy in children with plaque psoriasis would need to be substantial in order to justify its approval and usage in the pediatric psoriasis population,” explains a spokesperson for the FDA.
Labels Updated
The FDA has agreed, whether the medication is approved for children with psoriasis, the labels are in need of updates.
The updates come in the aftermath of reports involving malignancies, infections and neurological problems among patients.
(Source: CNN)
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