FDA REQUESTS STRONGER WARNING FOR PAXIL
The FDA has called on GlaxoSmithKline (GSK) to strengthen the warning on its
top-selling antidepressant Paxil to alert consumers that clinical studies in
pregnant women demonstrate the drug poses a risk to the fetus.
The agency's requested labeling change comes roughly nine weeks after GSK sent
a letter to physicians warning that pregnant women exposed to Paxil (paroxetine
HCl) or Paxil CR (paroxetine HCl controlled-release tablets) during the first
trimester were more than twice as likely to have a child with birth defects
than women taking other antidepressants. GSK's warning was based on preliminary
data from a GSK-led retrospective epidemiologic study involving nearly 3,600
pregnant women, according to the letter.
Based on the preliminary data, GSK updated Paxil's labeling to reflect the clinical
trial results. Since that time, data from a second study has emerged, suggesting
similar health risks in pregnant women, the FDA said. The second study showed
that the risk of heart defects in infants whose mothers had taken Paxil in the
first three months of pregnancy was 1.5 percent, compared to 1 percent on mothers
who took other antidepressants. GSK has also updated its labeling to reflect
the preliminary data from the second trial, the agency said.
The FDA has also asked GSK to change the pregnancy category on Paxil's labeling
from "C" to "D," a stronger warning. Category D means that
controlled or observational studies in pregnant women have demonstrated a risk
to the fetus. Category C indicates there are no adequate or well-controlled
studies in humans to determine the effect of the drug on the fetus.
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