Antipsychotic Medication During Pregnancy Does Affect Babies
A 7-year study of women who take antipsychotic medication while pregnant, proves it can affect babies.
The observational study, published in the journal PLOS ONE, reveals that whilst most women gave birth to healthy babies, the use of mood stabilisers or higher doses of antipsychotics during pregnancy increased the need for special care after birth with 43% of babies placed in a Special Care Nursery (SCN) or a Neonatal Intensive Care Unit (NICU) - almost 3 times the national rate in Australia.
As well as an increased likelihood of the need for intensive care, the study showed that antipsychotic drugs affects babies in other ways, with 18% being born prematurely, 37% showed signs of respiratory distress, and 15% developed withdrawal symptoms.
Jayashri Kulkarni, MD, Monash Alfred Psychiatry Research Centre (MAPrc), Monash University, Melbourne, Australia, said the study highlights the need for clearer health guidelines when antipsychotic drugs are taken during pregnancy.
“There’s been little research on antipsychotic medication during pregnancy and if it affects babies,” he said. “The lack of data has made it very difficult for clinicians to say anything conclusively on how safe it is for babies. This new research confirms that most babies are born healthy, but many experience neonatal problems such as respiratory distress.”
With no existing data to draw on, MAPrc established the world-first National Register of Antipsychotic Medications in Pregnancy (NRAMP) in 2005. Women who were pregnant and taking antipsychotic medication were recruited from around Australia through clinical networks in each state and territory. In all 147 women were interviewed every 6 weeks during pregnancy and then followed until their babies were aged 1 year.
The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to treat symptoms of psychiatric disorders, such as bipolar disorder and schizophrenia.
The new labeling standards are for older antipsychotic drugs as well as newer ones. The FDA says its labeling change is intended to address the potential risk for abnormal muscle movements, called extrapyramidal signs (EPS), and withdrawal symptoms in newborns whose mothers were treated with antipsychotic drugs in the third trimester of pregnancy.
The FDA says the labeling change affects these antipsychotic drugs:
Abilify
Clozaril
FazaClo
Fanapt
Geodon
Haldol
Invega
Loxitane
Moban
Navane
Orap
Risperdal
Saphris
Seroquel
Stelazine
Symbyax
Thorazine
Zyprexa
The FDA says in a statement on its web site that health care professionals “should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy.”
The agency warns that patients taking the drugs should not stop using their medications if they become pregnant without talking to their doctors or other health care professional. The FDA says that “abruptly stopping antipsychotic medications can cause significant complications for treatment.”
“The potentially harmful effects of taking an antipsychotic drug in pregnancy have to be balanced against the harm of untreated psychotic illness,” said Dr. Kulkarni. “The good news is we now know there are no clear associations with specific congenital abnormalities and these drugs.”
“However clinicians should be particularly mindful of neonatal problems such as respiratory distress, so it’s critical that Neonatal Intensive Care Units, or Special Care Nurseries are available for these babies,” he added.
Antipsychotic drugs are currently used to treat a range of psychiatric disorders including schizophrenia, major depression and bipolar disorder. About 20 per cent of Australian women experience depression in their lifetime, compared to 10 per cent of men. In Australia 25 per cent of women experience postnatal depression and 20 per cent experience severe menopausal depression.
Women have much higher rates of anxiety disorders and there are equal percentages of men and women with schizophrenia (2 per cent) and bipolar disorder (about 3 per cent).
Professor Kulkarni said the emergence of new antipsychotic drugs means that many women with a well controlled psychiatric disorder are able to contemplate having babies, but there have always been concerns about the effect of treatment on their offspring.
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SOURCE: Monash University