FDA weighs risk of antipsychotic drugs for kids

RUETERS
Three antipsychotic drugs appear to work in children and teens but their risks must be weighed as the makers aim to promote the medicines for youth, U.S. drug reviewers said in documents released on Friday.

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 and teens with schizophrenia or bipolar disorder. All three are blockbuster medicines already sold for adults.

An FDA panel meets next week to make recommendations on the companies' bids to promote the drugs for children and teens.

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.

"We generally are in agreement that the sponsors have provided adequate support to suggest effectiveness," Dr. Thomas Laughren, director of the FDA's psychiatry drugs division, wrote in a May 8 memo prepared for the advisory panel.

The risks for children appeared "to be qualitatively similar to those observed" with adults, he added.

Still, all of the medicines "have significant risks that must be considered," Laughren said.

Two similar medicines, Johnson & Johnson's Risperdal and Bristol-Myers Squibb Co's Abilify, are already approved to treat the diseases in younger patients.

The drugs, called atypical antipsychotics, are widely used for various mental illnesses but have drawn scrutiny for complications including weight gain and blood sugar increases, prompting concern about diabetes.

Risks from the three drugs under review "are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades," Laughren said.

Schizophrenia causes hallucinations, delusions and disorganized thoughts while bipolar disorder causes dramatic mood swings from manic episodes to depression. Laughren noted both are serious illnesses that place "a substantial burden for both patients and their families."

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.

Some FDA reviewers urged an extension of a current heart-related warning for adults taking Geodon to children.

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 and the risks for children were similar to adults, except that sedation and sleepiness were higher in kids. A study of children with bipolar disorder showed a "low propensity" for weight gain, the company said.

Lilly is asking to sell Zyprexa, its top drug, for bipolar episodes or schizophrenia in patients ages 13 to 17 after other treatments are tried first. FDA staff backed the drug as a second-choice treatment, saying it had a higher risk for weight gain and other problems compared with Risperdal and Abilify.

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.

The FDA staff documents and company statements can be found on the FDA's website at:here s/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/ucm164276.htm

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(Reporting by Lisa Richwine and Susan Heavey; Editing by Toni Reinhold and Tim Dobbyn)