By Lisa Richwine and Susan Heavey

FDA weighs risk of antipsychotic drugs for kids

The Food and Drug Administration is considering whether to approve AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly and Co’s Zyprexa for children . All three are blockbuster medicines already sold for adults.

Doctors can already prescribe them for children, but FDA approval would allow companies to promote the drugs, with combined sales of over $10 billion a year, more widely.

Two similar medicines, Johnson & Johnson’s Risperdal and Bristol-Myers Squibb Co’s Abilify, are already approved

Pfizer has applied for approval of Geodon for acute treatment of bipolar disorder in 10- to 17-year-olds. Geodon’s sales topped $1 billion in 2008.

Geodon’s labeling should note that children also risk QT prolongation, a type of irregular heartbeat that in rare cases increases the chance of sudden death, FDA clinical reviewer Mark Ritter wrote in another memo released on Friday.

He said data suggest children are “at least as sensitive” to QT prolongation from Geodon “and may potentially be at greater risk” for serious irregular heartbeats.

Pfizer said Geodon was well-tolerated overall

Lilly is asking to sell Zyprexa, its top drug, for bipolar episodes or schizophrenia in patients ages 13 to 17

Lilly, in a separate summary released by the FDA, said Zyprexa’s potential side effects were similar with children and adults and its current label “clearly communicates the risks.” Zyprexa had 2008 sales of $4.7 billion.

AstraZeneca is seeking approval of Seroquel for acute treatment of schizophrenia in teens, and for acute treatment of bipolar mania in ages 10 to 17. Seroquel is the second-best-selling product for AstraZeneca with 2008 sales of $4.5 billion.

Company spokeswoman Kirsten Evraire said there was “an unmet medical need” for treating children with the conditions despite the approved therapies. Seroquel offers a “positive benefit-risk profile” for youth with the disorders, she said.

Full article


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