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.
Lexapro and Celexa are two versions of the same drug, citalopram, and approved by the Food and Drug Administration for use only in 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.
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.
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
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.
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.
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
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
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.
