Psychiatric News July 16, 2004
Volume 39 Number 14
© 2004 American Psychiatric Association
p. 33
FDA Committee Urges New Warning On Antidepressants for Pregnancy
Jim Rosack
An FDA advisory committee says that despite a lack of conclusive data
about potential harm, antidepressant labels should warn pregnant women that
use of the medication could cause their newborn to suffer through
withdrawal.
The Pediatric Advisory Subcommittee of the Food and Drug Administration
(FDA) has advised the agency to require new warning language in the labels of
SSRI and SNRI antidepressants and in patient-information materials. The
labeling would inform patients that antidepressants taken by pregnant women
may result in a newborn experiencing a potentially significant withdrawal
syndrome.
"The point here is we've all been talking about giving the
information out to the doctors, and that is important, but you also have to
give it to the mother," said subcommittee member Judith O'Fallon, Ph.D.,
a researcher at the Mayo Clinic.
The FDA nearly always follows the advice of its advisory committees;
however, it is not legally bound to do so.
The pediatric subcommittee vote was the result of a June meeting in which
postmarketing adverse-event reports were reviewed for a number of drugs,
including venlafaxine–extended release (Effexor XR). Under the Pediatric
Research Equity Act of 2003, all drug manufacturers must submit data to the
FDA on postmarketing adverse events reported in pediatric populations.
In conjunction with the committee's regular review of postmarketing reports
of venlafaxine, the subcommittee added consideration of the proposed warning
language to its agenda and included a review of all pertinent reports
involving antidepressants.
The committee voted to recommend the warning language to the FDA for all
serotonin reuptake inhibitors and norepinephrine reuptake inhibitors, even
though the agency's data do not conclusively link the medications to fetal
toxicity. The agency has received reports of neurological, neuromuscular, and
autonomic effects in newborns whose mothers were taking fluoxetine (Prozac),
paroxetine (Paxil), citalopram (Celexa), venlafaxine (Effexor), sertraline
(Zoloft), and fluvoxamine (Luvox). Infants have exhibited agitation,
irritability, trouble feeding, and sleep disturbances that regulators believe
could be signs or symptoms of a withdrawal syndrome. In addition, some infants
have experienced respiratory distress, cyanosis, apnea, seizures, hypertonia,
hyperreflexia, and tremor.
The subcommittee members voted to not issue a public health advisory at
this time or recommend that the FDA require antidepressant manufacturers to
issue "Dear Healthcare Provider" letters. They were concerned that
doing so would scare pregnant women away from treatment, based on what is now
only preliminary information. Clearly more research needs to be undertaken,
members said, but in the mean-time, they strongly supported physician
education as an additional means of communicating the potential risks to
newborns.
The subcommittee specifically voted to recommend approval of proposed class
labeling for all SSRI/SNRIs within the pregnancy section of the label. The
proposed wording states:
"Neonates exposed to SSRI/SNRI antidepressants late in the third
trimester have developed AEs [adverse events] requiring prolonged
hospitalization, respiratory support, tube feeding. AEs may arise immediately
upon delivery."
In addition, under the dosage and administration section of the labeling,
physicians will be advised to taper dosage of the antidepressant during the
last trimester so that the fetus receives no drug through the placenta for at
least seven to 10 days prior to delivery. 
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