Forest accused of illegal promotion

US drugmaker Forest Laboratories has been accused of promoting two of  its antidepressants, Lexapro (escitalopram) and Celexa (citalopram),  for unapproved use in children and of paying kickbacks to physicians to  prescribe these drugs.

In the complaint, unsealed in the US District Court in Massachusetts, it  was alleged that the company's illegal promotional practices "caused  thousands of false and fraudulent claims to be submitted to federal  health programs." This also pointed to a double-blind,  placebo-controlled pediatric trial that found Celexa no more effective  than a dummy pill for use in children and that, in the study, more  patients taking the drug attempted suicide or reported suicidal thoughts  than those in the control arm. This led the US Food and Drug  Administration to deny approval for the drug's pediatric use.

It is further alleged that, despite the FDA's denial of a pediatric  indication, Forest actively promoted pediatric use of the drugs and  misled physicians and the public by failing to disclose the results of  the negative study. The same study was among those later considered by  the FDA when it mandated that Forest add a "black box warning to both  the Celexa and Lexapro labels.The complaint claims that the drugmaker  sought to induce physicians and others to prescribe Celexa and Lexapro  by providing them with various forms of illegal remuneration, including  cash payments disguised as grants or consulting fees, expensive meals  and lavish entertainment and other valuable goods and services, all in  violation of the federal anti-kickback statute.