SAN ANTONIO — Study data from the National Pregnancy Registry for Atypical Antipsychotics indicate it is unlikely for second-generation antipsychotics to raise risk of major malformations in pregnancy beyond the 10-fold increase found in the general population, said a study co-author here at the U.S. Psychiatric and Mental Health Congress.
The primary goal of the registry is major malformation frequency in infants exposed to atypical antipsychotics during pregnancy, according to Marlene P. Freeman, MD, of Harvard Medical School and Massachusetts General Hospital. These malformations include heart defects, cleft lip or neural defects. The Registry is based at the Center for Women’s Mental health at Massachusetts General Hospital.
Marlene P. Freeman
The most recently reported data included 487 women age 18 to 45 years (353 pregnant women who used second-generation antipsychotics and 134 controls). Women were contacted three times by phone in an 8-month period — twice during pregnancy and once post-partum.
Of live births that had exposure to second-generation antipsychotics, there were 3 major malformations (absolute risk: 1.4%). The control group had 1 major malformation (absolute risk: 1.1%).
Data “basically did not show an increased risk of major malformations,” Freeman said.
The study is still enrolling, she said.
“If you have woman in your practice who is pregnant, she can be in a registry or she can be a control. And that, in my mind, is such a precious gift if a woman is motivated to do it,” she said, and suggested that the attendees of the Congress contact her about the registry.
“We can send you flyers and other materials for your office,” she said.
“Not only do we have the Atypical Registry but we now have an Antidepressant Registry and a Stimulant Registry, Freeman said. – by Joan-Marie Stiglich, ELS
Freeman MP. Collaborative medical decision making for providers and patients for pregnancy: The new FDA pregnancy labels and what the mean. Presented at: U.S. Psychiatric and Mental Health Congress; Oct. 21-24, 2016; San Antonio.
Cohen et al. Reproductive safety of second-generation antipsychotics: Current data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. American Journal of Psychiatry. 2016;173(3):263-270.
: Freeman reports receiving research support from GlaxoSmithKline and Takeda; serving on advisory boards for Takeda/Lundbeck, Otsuka, Genentech, and Johnson and Johnson; serving as consultant for JDS Therapeutics; and performing medical editing for DSM Nutritionals and GOED Omega-3.