 Warning! Depression Med, Lexapro, Linked to Pediatric Suicide Approved by FDA for Kids
Source: www.yourlawyer.com Parker Waichman Alonso LLP Date: 4/3/09
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.
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