* Reviewers urge more study of weight gain, related issues
* Lilly, AstraZeneca drugs win new US approvals in kids
* Lilly says Zyprexa risks higher for youths than adults
(Adds Zyprexa approvals in adolescents, company comments)
By Lisa Richwine
WASHINGTON, Dec 4 U.S. drug reviewers have
urged regulators to take another look at the effects of newer
antipsychotic medicines on children following reports of weight
gain and other problems, a report released on Friday said.
Food and Drug Administration staff said a recent study of
health insurance claims found children treated with the drugs
"were much more likely to experience an adverse metabolic
effect than adults, and the likelihood was directly correlated
Metabolic effects can include abnormal weight gain,
diabetes and increases in cholesterol, blood pressure and blood
"Although observational studies have limitations ... this
provocative hypothesis should nonetheless be subject to some
further evaluation by the agency," staff in the FDA's division
of pharmacovigilance wrote in an Oct. 14 memo.
The memo was released as AstraZeneca (AZN.L) and Eli Lilly
(LLY.N) announced FDA approval of their antipsychotics for
younger patients. Astra's Seroquel was cleared for
schizophrenia patients ages 13 to 17 and bipolar disorder
patients ages 10 to 17, while Lilly's Zyprexa was approved for
schizophrenia and bipolar disorder in ages 13 to 17.
The drugs are in class known as atypical antipsychotics,
the newer family of antipsychotic medicines. Both classes of
drugs block the action of dopamine in the brain, but the newer
medicines act on other brain chemicals as well.
The atypical antispychotics are approved to treat
schizophernia, bipolar disorder, depression and and other
mental illnesses. The medicines also are increasingly
prescribed to children for unapproved uses such as attention
deficit hyperactivity disorder, or ADHD.
The FDA reviewed the drugs' use in children after a panel
of outside advisers in November 2008 asked for more long-term
data on the drugs' effects in youths. The agency will discuss
its most recent findings at a public meeting of that panel on
The report released on Friday said an FDA analysis showed
increased reporting of metabolic problems with Zyprexa and
Seroquel. Those findings "by themselves may not reflect true
agent-specific differences in risk," the agency staff added.
Reporting rates jumped for Zyprexa in 2006 and for Seroquel
in 2007, the FDA staff said. Those spikes may be partly
explained by cases submitted by law firms involved in suits
against the companies, the reviewers said.
Zyprexa already carries a warning that it appears to carry
increased metabolic risk over other atypical antipsychotics,
and FDA staff said that may have stimulated more reports of
problems with the drug.
Lilly spokesman Jamaison Schuler said the company has
acknowledged greater risks for younger patients treated with
"Clinicians should take into consideration the increased
potential for weight gain and (elevated blood fats) in
adolescents compared to adults, and the potential for long-term
risks, which in many cases may lead them to consider
prescribing other drugs first," Schuler said.
The FDA staff memo, written before Friday's approval of
Seroquel for adolescents, recommended the Seroquel data undergo
further review as was previously done for Zyprexa.
In a statement announcing Seroquel's approval for youths,
AstraZeneca said the drug's warnings were updated to include
information about weight gain and other issues seen in the
studies of adolescents.
Zyprexa is Lilly's top-selling drug with sales of $4.7
billion last year. Seroquel is the second-best seller for
AstraZeneca with 2008 sales of $4.5 billion.
The FDA review also included Bristol-Myers Squibb Co
(BMY.N) and Otsuka Pharmaceutical Co's Abilify, Johnson &
Johnson's (JNJ.N) Risperdal and Pfizer Inc's (PFE.N) Geodon.
Bristol-Myers and Otsuka monitor Abilify's safety,
including metabolic effects, and "welcome discussion in medical
and scientific forums to help ensure informed treatment
decisions," Bristol-Myers spokeswoman Sonia Choi said.
Johnson & Johnson spokesman Srikant Ramaswami said the
company had just received the FDA report and had not fully
A Pfizer spokeswoman did not immediately respond to a
request for comment.
(Reporting by Lisa Richwine; Editing by Steve Orlofsky, John
Wallace and Carol Bishopric)
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