ADELPHI, Md. (AP) – Advisers to the Food and Drug Administration say three psychiatric drugs appear safe and effective for children and adolescents, despite side effects that can increase the risk of diabetes.
The FDA’s panel of experts voted to affirm that drugs from AstraZeneca, Eli Lilly and Pfizer appear safe and useful for treating schizophrenia and bipolar disorder in patients ages 10 to 17.
All three drugs already are approved for adults with schizophrenia and bipolar disorder.
The FDA is not required to follow the group’s advice, though it usually does. A positive FDA decision would expand the use of drugs that already make up 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.
THIS IS A BREAKING NEWS UPDATE. The earlier story is below.
ADELPHI, Md. (AP) – Advisers to the Food and Drug Administration say a psychiatric drug from AstraZeneca is safe and effective for children and adolescents, despite side effects that can increase the risk of diabetes.
The FDA’s panel of experts has voted overwhelmingly that Seroquel is a useful treatment for schizophrenia and bipolar disorder in patients ages 13 to 17. The group also voted 8-1 that Pfizer’s Geodon is safe for children and adolescents with bipolar disorder, though nine panelists abstained, complaining of incomplete data from the company.
The group also is weighing expanded approval of Eli Lilly’s Zyprexa. All three drugs already are approved for adults with schizophrenia and bipolar disorder.
The FDA is not required to follow the group’s advice, though it usually does.
Date: June 9, 2009
Source: Associated Press