It might sound like a candidate for the So What? award, but the FDA's approval of the "atypical" antipsychotic Risperdal for use in children and adolescents is a landmark decision. The drug is already commonly used in kids, but there's been a lack of clinical data to support its effectiveness and/or safety. And the drug, like others in its class, carries some serious side effects, including weight gain that can lead to diabetes.
With the FDA's endorsement--based on a handful of short-term studies the agency requested--doctors may feel more comfortable reaching for their prescription pads to order the Johnson & Johnson drug, which is used against schizophrenia and bipolar disorder. Already J&J's best-selling drug, with some $4 billion in sales per year, Risperdal may get a bump upward with this decision, but it's set to lose patent protection next year.
Previously, lithium was the only drug approved for use in adolescents with bipolar disorder, and there's been no drug--that's right, not one--approved for kids with schizophrenia. But keep an eye on Risperdal: the FDA granted approval without running the new study data by an advisory panel, and plenty of doctors think older, less expensive drugs are safer and more effective. The debate will continue.
- check out the release
- read the Boston Globe report
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