More conclusive link needed on teratogenicity and atypicals in pregnancy

CHICAGO – If you’re currently treating any pregnant patients who are taking atypical antipsychotics, Dr. Marlene P. Freeman and her colleagues, who’ve started a national registry for tracking these data, hope to hear from you.

"We also need information not just on patients who are taking antipsychotics but also on those who aren’t, so that we can expand the number of controls," Dr. Freeman said in an interview during Psychiatry Update 2014, cosponsored by the American Academy of Clinical Psychiatrists and Current Psychiatry.

"Our registry is carefully, prospectively done," said Dr. Freeman while speaking at the meeting. "It’s all done by phone, with two calls during pregnancy and one post partum."

Findings based on data collected before June 2013 and presented at a teratogenicity meeting last year were "not unblinded in terms of what medications were associated with what outcomes or who the controls were," she said. However, so far the trend is that antipsychotic use isn’t likely going to turn out to be as adverse as valproic acid, the anticonvulsant that ultimately was found associated with teratogenicity, said Dr. Freeman, who is the clinical director of Women’s Mental Health Center at Massachusetts General Hospital in Boston, where the registry is housed. "Rates of malformations [found in the registry data so far] were at or below the rates in the general population," she said, adding that definitive results are still needed.

At this time, more than 400 patients are enrolled in the registry, which began in 2011 in an effort to build a definitive database on teratogenicity and atypicals in pregnancy. According to Dr. Freeman, a German study published recently showed no significant difference between rates of major malformations between those exposed to first-generation antipsychotics or second-generation atypicals during the first trimester (J. Clin. Psychopharm. 2013;33:453-62). However, compared with controls, the major malformation rate was just over two times greater among those exposed to atypicals.

Meanwhile, a prospective Canadian study also cited by Dr. Freeman did not find a significant difference in congenital malformations between children born to mothers taking atypicals, compared with controls (BMJ Open 2013;3:e003062 [doi:10.1136/bmjopen-2013-003062]).

According to Dr. Freeman, the need for clear, substantial data is important, because the use of atypicals in pregnancy is on the rise. A study published last year and cited by Dr. Freeman found that among 585,615 U.S. deliveries that occurred during 2001-2007 with prescriptions dispensed to the mother between 60 days before or on the date of delivery, 0.72% received an atypical antipsychotic and 0.09% received a typical antipsychotic (Arch. Womens Ment. Health 2013;16:149-57). There was a 2.5-fold increase in atypicals prescribed over the course of the study period. Depression was the most common mental health diagnosis (63%), followed by bipolar disorder (43%), and schizophrenia (13%).

Dr. Freeman disclosed she has industry relationships with GlaxoSmithKline, Takeda/Lundbeck, and Genentech, among others. Current Psychiatry and this news organization are owned by the same parent company.

For more information on the National Pregnancy Registry, click here.

[email protected]

On Twitter @whitneymcknight

CHICAGO – If you’re currently treating any pregnant patients who are taking atypical antipsychotics, Dr. Marlene P. Freeman and her colleagues, who’ve started a national registry for tracking these data, hope to hear from you.

"We also need information not just on patients who are taking antipsychotics but also on those who aren’t, so that we can expand the number of controls," Dr. Freeman said in an interview during Psychiatry Update 2014, cosponsored by the American Academy of Clinical Psychiatrists and Current Psychiatry.

"Our registry is carefully, prospectively done," said Dr. Freeman while speaking at the meeting. "It’s all done by phone, with two calls during pregnancy and one post partum."

Findings based on data collected before June 2013 and presented at a teratogenicity meeting last year were "not unblinded in terms of what medications were associated with what outcomes or who the controls were," she said. However, so far the trend is that antipsychotic use isn’t likely going to turn out to be as adverse as valproic acid, the anticonvulsant that ultimately was found associated with teratogenicity, said Dr. Freeman, who is the clinical director of Women’s Mental Health Center at Massachusetts General Hospital in Boston, where the registry is housed. "Rates of malformations [found in the registry data so far] were at or below the rates in the general population," she said, adding that definitive results are still needed.

At this time, more than 400 patients are enrolled in the registry, which began in 2011 in an effort to build a definitive database on teratogenicity and atypicals in pregnancy. According to Dr. Freeman, a German study published recently showed no significant difference between rates of major malformations between those exposed to first-generation antipsychotics or second-generation atypicals during the first trimester (J. Clin. Psychopharm. 2013;33:453-62). However, compared with controls, the major malformation rate was just over two times greater among those exposed to atypicals.

Meanwhile, a prospective Canadian study also cited by Dr. Freeman did not find a significant difference in congenital malformations between children born to mothers taking atypicals, compared with controls (BMJ Open 2013;3:e003062 [doi:10.1136/bmjopen-2013-003062]).

According to Dr. Freeman, the need for clear, substantial data is important, because the use of atypicals in pregnancy is on the rise. A study published last year and cited by Dr. Freeman found that among 585,615 U.S. deliveries that occurred during 2001-2007 with prescriptions dispensed to the mother between 60 days before or on the date of delivery, 0.72% received an atypical antipsychotic and 0.09% received a typical antipsychotic (Arch. Womens Ment. Health 2013;16:149-57). There was a 2.5-fold increase in atypicals prescribed over the course of the study period. Depression was the most common mental health diagnosis (63%), followed by bipolar disorder (43%), and schizophrenia (13%).

Dr. Freeman disclosed she has industry relationships with GlaxoSmithKline, Takeda/Lundbeck, and Genentech, among others. Current Psychiatry and this news organization are owned by the same parent company.

For more information on the National Pregnancy Registry, click here.

[email protected]

On Twitter @whitneymcknight

CHICAGO – If you’re currently treating any pregnant patients who are taking atypical antipsychotics, Dr. Marlene P. Freeman and her colleagues, who’ve started a national registry for tracking these data, hope to hear from you.

"We also need information not just on patients who are taking antipsychotics but also on those who aren’t, so that we can expand the number of controls," Dr. Freeman said in an interview during Psychiatry Update 2014, cosponsored by the American Academy of Clinical Psychiatrists and Current Psychiatry.

"Our registry is carefully, prospectively done," said Dr. Freeman while speaking at the meeting. "It’s all done by phone, with two calls during pregnancy and one post partum."

Findings based on data collected before June 2013 and presented at a teratogenicity meeting last year were "not unblinded in terms of what medications were associated with what outcomes or who the controls were," she said. However, so far the trend is that antipsychotic use isn’t likely going to turn out to be as adverse as valproic acid, the anticonvulsant that ultimately was found associated with teratogenicity, said Dr. Freeman, who is the clinical director of Women’s Mental Health Center at Massachusetts General Hospital in Boston, where the registry is housed. "Rates of malformations [found in the registry data so far] were at or below the rates in the general population," she said, adding that definitive results are still needed.

At this time, more than 400 patients are enrolled in the registry, which began in 2011 in an effort to build a definitive database on teratogenicity and atypicals in pregnancy. According to Dr. Freeman, a German study published recently showed no significant difference between rates of major malformations between those exposed to first-generation antipsychotics or second-generation atypicals during the first trimester (J. Clin. Psychopharm. 2013;33:453-62). However, compared with controls, the major malformation rate was just over two times greater among those exposed to atypicals.

Meanwhile, a prospective Canadian study also cited by Dr. Freeman did not find a significant difference in congenital malformations between children born to mothers taking atypicals, compared with controls (BMJ Open 2013;3:e003062 [doi:10.1136/bmjopen-2013-003062]).

According to Dr. Freeman, the need for clear, substantial data is important, because the use of atypicals in pregnancy is on the rise. A study published last year and cited by Dr. Freeman found that among 585,615 U.S. deliveries that occurred during 2001-2007 with prescriptions dispensed to the mother between 60 days before or on the date of delivery, 0.72% received an atypical antipsychotic and 0.09% received a typical antipsychotic (Arch. Womens Ment. Health 2013;16:149-57). There was a 2.5-fold increase in atypicals prescribed over the course of the study period. Depression was the most common mental health diagnosis (63%), followed by bipolar disorder (43%), and schizophrenia (13%).

Dr. Freeman disclosed she has industry relationships with GlaxoSmithKline, Takeda/Lundbeck, and Genentech, among others. Current Psychiatry and this news organization are owned by the same parent company.

For more information on the National Pregnancy Registry, click here.

[email protected]

On Twitter @whitneymcknight