Drug Maker Accused of Illegally Marketing Antidepressants for Kids and Teens

Forest Laboratories, the maker of the popular brand-name antidepressants Lexapro and Celexa, illegally marketed the drugs for use in children and teens while hiding data showing the drugs were not as effective as other drugs and increased the risk of suicide in younger people, according to U.S. prosecutors.

Lexapro and Celexa are two versions of the same drug, citalopram, and approved by the Food and Drug Administration for use only in adults. They belong to a family of drugs called selective serotonin reuptake inhibitors (SSRIs) and have been prescribed to millions of adults in the United States for the treatment of depression and generalized anxiety disorder, two conditions which affect about 27 million American adults.

Lexapro is Forest’s best-selling drug, earning the company $2.3 billion in 2008 alone. The company has asked the FDA to approve the drug for use in treating depression in adolescents.

Negative Study Results Were Concealed

The Justice Department charged Forest Laboratories with illegally marketing Lexapro and Celexa from 2001 to 2004 by disclosing the positive results of a clinical study of the drugs without also releasing data showing the drugs were not effective in many children and could result in some young patients becoming suicidal.

In doing so, prosecutors allege, Forest told prescribing physicians a “half-truth” about the drugs and exposed pediatric patients to increased risk of suicide. It is illegal for drug companies to promote the use of drugs for treating medical conditions for which the drugs have not been FDA-approved.

Government Seeking Millions Paid for Improper Prescriptions

Prosecutors also are seeking to recover money paid for prescriptions of the drugs for children under federal health-care benefits programs. That amount could reach millions of dollars, although an amount being sought was not specified in the government’s complaint filed against Forest.

Forest also is accused of giving tickets to baseball games, gift certificates to expensive restaurants, and other forms of kickbacks to doctors who prescribed its drugs. Some physicians were sent on vacations paid for by the company, prosecutors allege.

New Disclosure Rules Are In Place

Drug companies are now required to disclose the results of all their clinical trials, regardless of whether the results are positive or negative. However, Forest’s marketing of Celexa and Lexapro to adolescents and children happened before those rules were in place.

Studies Showing Negative Results Were Hidden

Forest knew about two studies conducted in the 1990s regarding the use of Celexa to treat depression in children, according to federal prosecutors. One study reached positive results about the use, while the other came to a negative conclusion on the issue, officials said.

For years, Forest officials cited the positive study results to physicians in encouraging Celexa as a treatment for pediatric depression, but failed to disclose the negative study findings, prosecutors said.

Many physicians continue to prescribe Lexapro and Celexa to treat depression in children. The drugs carry a prominent “Black Box” warning to advise doctors and patients about the increased risk of suicide in children and teens.

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