Depression Med Linked to Pediatric Suicide Approved by FDA for KidsMar 24, 2009 | Parker Waichman LLP
Although it has long been known that antidepressants are dangerous for pediatric patients, Forest Laboratories just announced that its antidepressant Lexapro (escitalopram oxalate) has been approved for major depressive disorder (MDD) in children aged 12 to 17 reports HealthDay News.
According to Forest Laboratories, about two million teenagers in this country have experienced MDD in the past year, said HealthDay News; a fact used to market Lexapro to young patients despite evidence showing that Lexapro promotes suicidal thoughts in pediatric patients. The U.S. Justice Department recently charged Forest Labs for such inappropriate marketing to children. Now, less than one month later, Forest Labs received approval for Lexapro to be prescribed to the very group it was accused of improperly marketing, points out Modern Medicine.
In a prior Wall Street Journal (WSJ) article, the same prosecutors charged Forest Labs with violating anti-kickback laws by paying doctors to prescribe Lexapro to vulnerable, pediatric patients. The suit also accused Forest Labs of violating the False Claims Act when it marketed the drug and accuses Forest of covering up a medical study that concluded that Lexapro and Celexa—another antidepressant—were not effective medications for children, said WSJ. An earlier Bloomberg.com article said the complaint charges that Forest was unwavering in its marketing of the drugs.
Knowing that the drugs were ineffective in children and could also cause suicidal thoughts in pediatric patients, Forest went ahead and promoted Lexapro and Celexa for use in children, going so far as to cite a study that was more conducive to its needs, hiding the negative findings. Meanwhile, the U.S. Food and Drug Administration (FDA) had not approved the drugs for use in children at that time.
Lexapro was approved for adults in 2002 and is one of a class of antidepressants called selective serotonin reuptake inhibitors—or SSRIs. Lexapro and other similar drugs now include a “black box” warning label indicating that the medications are linked with an increased risk of “suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders,” quoted HealthDay News, adding that those considering Lexapro use in pediatric patients “must balance this risk with the clinical need.”
Reuters said federal prosecutors alleged both Lexapro and Celexa have been inappropriately used to treat pediatric depression and that after a five-year investigation, the U.S. Justice Department accused Forest of urging pediatricians to prescribe the drugs, enticing them with bribes and perks, said Reuters. The complaint also accused Forest of ignoring a study that revealed that Celexa, which is chemically similar to Lexapro, was ineffective in children and then having its sales staff use a second study that with more positive outcomes for Lexapro’s pediatric use, reported Reuters.
Using the complimentary study, the FDA approved the controversial medication for use in the vulnerable population despite established research to the contrary and that the study used did not indicate the drug’s efficacy; Forest also admitted that there was no clinical proof that Lexapro could control symptoms in teens taking Celexa. Regardless, the FDA said such “maintenance efficacy” could be “extrapolated” from adult data.