The Justice Department has charged drug manufacturer Forest Laboratories with defrauding the government of millions of dollars after it, allegedly, illegally marketed popular antidepressants Lexapro and Celexa for unapproved uses in children and teenagers. Lexapro is Forest Lab’s biggest seller, with total sales of $2.8 billion in 2008. In the civil complaint, filed by the United States Attorney’s office in Boston, prosecutors claimed that for many years, former top executives of the company concealed many clinical studies that showed the drugs were not effective in children and may even cause some to become suicidal. Although current rules demand companies provide the results of all clinical trials, the trials of Lexapro and Celexa date to before these rules were in place.
Prosecutors also claim Forest Labs provided kickbacks, such as baseball tickets and gift certificates to expensive restaurants, to physicians who prescribed the drugs. Though it did not specify a figure, the government is attempting to recover three times the amount of money spent by federal programs to pay for pediatric prescriptions of the two drugs.
From 2001 to 2004, Forest Labs heavily publicized the clinical research that showed the drugs were effective; it did not disclose the negative clinical trial results within the company or to outside researchers. Prosecutors claim that by this failure to disclose negative results, the company told a half-truth to doctors who prescribe the medication. While it is legal for doctors to prescribe medication to patients, including children, for whom the drugs are not yet approved by regulators, it is illegal for companies to advertise these uses.
Lexapro and Celexa are forms of the drug citalopram. The Food and Drug Administration (FDA) currently approves the use of the drugs for adults only, though doctors still widely use these drugs to treat children. Now, however, these drugs, including Lexapro and Celexa, carry a "black box" warning that states the drugs may create suicidal thoughts or behavior in children. Forest Labs does not currently have a comment regarding the situation.
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