FDA Approves Lilly Antipsychotic for Teens
From Associated Press (December 4, 2009)
INDIANAPOLIS,--Drug maker Eli Lilly & Co. said Friday it received U.S. approval to market its best-selling medication Zyprexa for adolescents with schizophrenia and manic depression.
The Food and Drug Administration approved the drug for adolescents aged 13 to 17 years old, but cautioned that the drug can cause weight gain and high blood sugar in younger patients.
New labeling for the drug will recommend physicians consider other treatments first, according to a statement from Lilly.
Zyprexa was Lilly’s top-selling medication last year with sales of $4.7 billion.
Earlier this year a medical study found that youngsters are more prone to gain weight when taking antipsychotics drugs than adults. The study in the Journal of the American Medical Association found children and teens can gain nearly 20 pounds and become obese within just 11 weeks.
Zyprexa and other antipsychotic medications are often prescribed to treat attention deficit disorder in young patients, although they are not formally approved for the use.
The FDA is slated to examine the weight-gain side effect in children at a hearing next week.
Antipsychotics have grown into the top-selling class of prescriptions in the U.S., with 2008 sales of $14.6 billion, according to health care analysis firm IMS Health.
Shares of Eli Lilly & Co. rose 49 cents, or 1.3 percent, to
$37.88 in afterhours trading after finishing the regular session
down one cent at $37,39.
Posted: December 2009