FDA Considers New Psychiatric Drugs for Children

The U.S. government is considering clearing three blockbuster psychiatric drugs currently taken by adults for use in children and adolescents, the Associated Press reported.

The drugs are now approved to treat schizophrenia and bipolar mania, also known as manic depressive disorder, in adults.

The Food and Drug Administration said the drugs appear to work in adolescents, but reviewers worry about exposing youngsters to the medications' side effects, which include weight gain, high blood pressure and sleepiness.

"These risks are of particular concern because of the lifelong nature of these disorders," Dr. Thomas Laughren, the FDA director for psychiatric products, wrote in documents posted online, the AP reported.

The issues will be discussed at a meeting Tuesday, when outside experts will voice their opinions about the drugs' risks and benefits. The FDA usually follows its advisory panels' advice, the AP said.

The drugs -- made by Pfizer Inc., Eli Lilly & Co. and AstraZeneca -- are currently approved to treat schizophrenia and bipolar mania in adults. Together, they accounted for $7.4 billion in sales last year, according to IMS Health, the AP said.

Many physicians already prescribe these drugs to children and teens. While it is permissible for doctors to prescribe as they see fit, pharmaceutical companies can only promote the drugs for FDA-approved uses, the APadded.

Source : www.empowher.com