The Justice Department charged the drug maker Forest Laboratories on Wednesday with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers.
In a civil complaint filed by the United States attorney’s office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal.
From 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives, the complaint said.
An official of Forest, which is based in Manhattan, said the company’s lawyers were reviewing the complaint and did not have an immediate comment. Celexa and Lexapro are two versions of the same drug, citalopram. The drugs are currently approved by the Food and Drug Administration only for adults.
By failing to disclose the negative trial results, prosecutors said in the complaint, “Forest told prescribing physicians a half-truth and thereby prevented them and the public from having all potentially available information when making decisions about how to treat a serious medical condition in pediatric patients.”
Doctors are free to prescribe drugs to patients, including children, for whom those drugs are not approved by federal regulators. But it is illegal for companies to actively promote such uses.
http://www.nytimes.com/2009/02/26/business/26drug.html?em
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