Popular Anti-Depressant Approved For Use in Children, Teens

Lexapro, a popular antidepressant recently linked to accusations of dishonest marketing tactics and illegal paybacks to physicians, has been approved by the Food and Drug Administration for use in children and teens.

Forest Laboratories Inc., the company behind the drug, has been accused of illegally marketing Lexapro to kids for years by trying to buy favor with pediatricians through vacations, tickets to sporting events, and other perks.

About two million adolescents in the United States suffer from major depressive disorder and Lexapro is now only the second anti-depressant approved for such younger patients.

Federal Accusations of Wrongdoing

In February 2009, federal prosecutors accused Forest of downplaying a study which showed Celexa, another Forest drug closely related to Lexapro, was not effective for use in children while continuing to promote another study, which reached a positive conclusion about using the drug in children.

Despite those serious allegations, the FDA found that favorable results from two recent clinical trials of Lexapro and Celexa warranted approving their use to treat major depressive disorder and as a maintenance therapy in adolescents between the ages of 12 and 17. The drugs were already approved for the uses in adults.

However, Forest admits that those studies, while successful, did not find that Lexapro and Celexa are effective in treating kids. Also, the company said Lexapro’s ability to maintain control over the symptoms of major depressive disorder in adolescents has not been shown.

Authorities claim that Medicare and other federal health care programs have paid “thousands of false and fraudulent claims for Celexa and Lexapro prescriptions that were not covered for off-label pediatric use and/or were ineligible for payment as a result of illegal kickbacks paid by Forest.”

Top-Seller Approved for Kids

Lexapro is a top-selling drug in the United States and is derived from Celexa, an older generation drug that has been mostly replaced by cheaper generic versions. Celexa, which is still approved to treat adult depression, was not approved by the FDA for use in children. The drug has been linked to increased risk of suicidal thoughts and attempted suicide.

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