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FDA Considers New Psychiatric Drugs for Children

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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.

Add a Comment4 Comments

EmpowHER Guest

What a scam to force children to take unapproved medications for profit, follow AstraZenica's contributions to congress and the timing of the FDA approvals.

June 10, 2009 - 5:39pm
EmpowHER Guest

The drug industry has promoted these drugs off-label to children and been sued by practically every state in the union and lost. The use of these drugs has skyrocketed with much harm done so it's the perfect solution to get FDA approval for the drugs so the money making can continue.

It's well known that Soteria House and other studies have shown that people left alone and not locked up and drugged tend to get better while drugging does bring about a lifelong consumer and a miserable person at the same time. The lawsuits barely scrap the surface of the profits.

Children's developing bodies do not need such toxic harsh drugs. Coming off the drugs is a nightmare so there is another plus for a life long consumer. What a farce and tragedy if these drugs are approved for children.

June 9, 2009 - 11:12am
EmpowHER Guest

Here is some more information about how FDA physicians state that antipsychotic drugs for kids may have benefits, but do come with risks: http://www.newsinferno.com/archives/6716#more-6716

June 8, 2009 - 4:40pm
EmpowHER Guest

I took Zyprexa a powerful schizophrenic drug for 4 years it was prescribed to me off-label for post traumatic stress disorder was ineffective costly and gave me diabetes.

This is a powerful drug that can damage a young person physiologically for life.Please take with caution and learn as much as you can about side effects.

Daniel Haszard http://www.zyprexa-victims.com

June 6, 2009 - 5:14am
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