The FDA is requiring a label change to the Pregnancy section of all antipsychotic drugs to note potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal in newborns whose mothers received these drugs during the third trimester of pregnancy.
Symptoms may include agitation, increased or decreased muscle tone, tremors, sleepiness, significant difficulty breathing, as well as difficulty feeding.
To report an adverse event from antipsychotics:
return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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