[NYAPRS Enews] FDA: New Cautions for Antipsychotic Drug Use by Pregnant Women

[Harvey Rosenthal]

FDA Orders New Cautions on Antipsychotic Drugs
By John Gever, Senior Editor, MedPage Today  February 22, 2010

 

WASHINGTON-All antipsychotic drugs, including older agents, as well as
second-generation products, must contain new label information regarding
their use in pregnancy, the FDA said. In particular, the new labeling
will address the risk of extrapyramidal symptoms (EPS) and withdrawal
syndromes in newborns.

"FDA has updated the Pregnancy section of drug labels for the entire
class of antipsychotic drugs to include consistent information about the
potential risk for EPS and/or withdrawal symptoms in newborns whose
mothers were treated with these drugs during the third trimester of
pregnancy," the agency said in a notification to health care
professionals.

The FDA has identified 69 episodes of neonatal EPS or withdrawal in
adverse event reports submitted to the agency through October 2008.
Among the symptoms listed in the reports: agitation, hypertonia,
hypotonia, tremor, somnolence, respiratory distress, and feeding
disorder.

However, blood levels of the drugs involved were not provided in the
reports, the agency said, so it was "not possible to determine whether
the events resulted from antipsychotic drug toxicity or withdrawal."

Onset of symptoms ranged from birth to 1 month later, and the severity
varied as well. The FDA indicated that some infants recovered within
hours, while others needed intensive care and prolonged hospitalization.
Most of the cases also involved other potential causes of the symptoms,
such as other psychotropic drugs and medical problems associated with
the pregnancy or delivery.

"However, there were some cases which suggest that neonatal EPS and
withdrawal may occur with antipsychotics alone," the FDA said.

The agency's announcement did not indicate which specific antipsychotic
drugs were named in the adverse event reports.

In any event, the FDA is requiring the standardized cautions be carried
on all antipsychotic drugs-20 different types sold under 23 brand names
are included in the order. These range from the first antipsychotic drug
used in modern practice, chlorpromazine (Thorazine), to such newer
agents as aripiprazole (Abilify) and quetiapine (Seroquel).

All the products are approved to treat schizophrenia; some also have
been cleared for bipolar disorder.

The official order can be read at:
http://www.fda.gov/Drugs/DrugSafety/ucm243903/ 

To watch the video clip, please visit:
http://www.cnn.com/video/data/2.0/video/politics/2011/01/16/sotu.01.16.f
rese.earley.cnn.html

 

http://www.medpagetoday.com/Psychiatry/Schizophrenia/25003 

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