08 | 31 | 2007 Posted By Regan Zambri & Long

FDA: Antipsychotic Drug Approved for Children, But Critics Disagree

The U.S. Food and Drug Administration (FDA) recently announced its approval of the antipsychotic drug Risperidone (marketed as Risperdal) for the treatment of schizophrenia in adolescents between 13 and 17 years of age, and for the treatment of bipolar I disorder in children and adolescents between the ages of 10 and 17.  It is the first atypical psychiatric drug ever approved to treat these disorders in children, and at least one human interest organization is concerned that the drug's approval came too easily.

The Alliance for Human Research Protection (AHRP), a 501(c)3 organization supporting human research ethics and human rights, has denounced the drug's approval as emblematic of the FDA's "slip shod safety review and approval process."  According to AHRP, the FDA quietly approved Risperdal for its new use without convening any advisory committee to evaluate the risks or benefits of the drug in children, bypassing public debate, and relying heavily on industry-sponsored research for safety information.  The agency also knew before it took action that Johnson & Johnson had withdrawn its application for pediatric approval of Risperdal in the United Kingdom after the U.K. Medicines Authority announced that it would condition its approval on the addition of further safety measures to protect children.

According to the AHRP, even some psychiatrists paid by pharmaceutical manufacturers admit that Risperdal causes severe, debilitating side effects.  The group cites evidence submitted in the course of litigation which demonstrates that Risperdal has raised prolactin levels so abnormally high in boys that some have grown breasts large enough to require mastectomies.  Weight gain typically associated with the drug also contributes to the development of type 2 diabetes.

Concerns over the drug's dangers are overshadowed by the fact that FDA approval should give Risperdal another significant boost in sales.  Currently, it is the second best-selling antipsychotic, with $2.6 billion in sales last year alone. 

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