|
 "We did not see a meaningful increase in risk for any of the drugs
with the exception of risperidone," said lead author Krista
Huybrechts, of Brigham and Women’s Hospital and Harvard Medical
School in Boston.
Women taking the antipsychotic risperidone were about 26 percent
more likely than women not taking antipsychotic drugs to give birth
to children with birth defects, the researchers report in JAMA
Psychiatry.
There is no biological reason risperidone would increase the risk of
birth defects while others don't, Huybrechts said, adding that the
finding is a safety signal that should be investigated.
"It definitely needs more study," she said. "We did a lot of
analyses to see if we could explain that observation and we
couldn't."
Because of concerns surrounding the unknown effects of experimental
drugs on women and fetuses, researchers have traditionally excluded
pregnant women from clinical trials. That exclusion has led to a
lack of information about the safety of some drugs during pregnancy,
Huybrechts' team writes.
For the new study, the researchers used data on over 1.36 million
U.S. pregnant women enrolled between 2000 and 2010 in Medicaid, the
government-run insurance program for the poor.
The researchers attempted to match women who were similar to each
other, except for taking antipsychotic medications. Then they looked
to see if the newborns of women taking antipsychotics were more
likely to be diagnosed with a birth defect in the first 90 days of
life than the children of women not using the drugs.
The researchers also looked for differences between outcomes
depending on which of the two main types of antipsychotics women
used. So-called typical antipsychotics work by similar mechanisms to
one another, but the second-generation atypical antipsychotics act
differently from their predecessors.
About 33 of 1,000 children not exposed to antipychotics in the womb
were diagnosed with birth defects. That compared to about 38 per
1,000 children exposed to typical antipsychotics and about 45
children per 1,000 who were exposed to atypical antipsychotics.
[to top of second column] |
But after adjusting the numbers to account for other factors that
may increase the risk of birth defects, the researchers found no
increased risk for either type of antipsychotic drug - with the
exception of risperidone.
Dr. Katherine Wisner, who co-wrote an editorial accompanying the new
research, said the amount of data and the methods used make this a
"landmark" study.
"For women taking other medications besides risperidone, it is
really solid data to show there is no identifiable increased risk of
birth defects," said Wisner, of the Northwestern University Feinberg
School of Medicine in Chicago.
Huybrechts cautioned that people should not draw the conclusion that
antipsychotics are completely safe during pregnancy. The research
team only looked at birth defects, which is one potential outcome
during pregnancy.
The team has plans to evaluate antipsychotic use for the risk of
gestational diabetes and other pregnancy related outcomes, she said.
SOURCE: http://bit.ly/2bdxBnk and http://bit.ly/2bdxCHU JAMA
Psychiatry, online August 17, 2016.
[© 2016 Thomson Reuters. All rights
reserved.] Copyright 2016 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
