The Risks of Anitpsychotic Drugs and Pregnancy

The FDA has published an alert about the risks for pregnant women of using antipsychotic medication in the final trimester of their pregnancy.
Agency scientists reviewing the FDA's Adverse Event database found 69 cases of mothers taking antipsychotic medications in their final trimester whose newborns suffered abnormal muscle movements and other withdrawal symptoms linked to antipsychotic medication.
Newborns' EPS and withdrawal symptoms may include any of the following: serious difficulty in breathing, problems in feeding, abnormal increase or decrease in muscle tone (too stiff or too flabby), tremors, and agitation.
Some newborns' symptoms resolved within hours or days without treatment; other infants required continued hospitalization for observation and treatment.
The FDA's alert included a recommendation to healthcare providers that they closely monitor all newborns whose mothers are being treated with antipsychotic medication for EPS and withdrawal symptoms.
In many of the cases in the FDA database, mothers were also being treated with other drugs that increased the risk of EPS, such as antidepressants, opioids, and benzodiazapines (a family of drugs used for anxiety and as sleep medications).
Prematurity, and mothers' health conditions such as placental problems and pre-eclampsia were also complicating factors in many cases.
Nonetheless, there were in the database instances of newborns who experienced EPS whose mothers did not have health conditions and were not taking any other drugs, and for whom maternal antipsychotic medication was the only apparent causal link.
Antipsychotic medications are often an essential part of the treatment plan for psychiatric disorders such as schizophrenia and bipolar disorder.
For many people who live with these disorders, the medications are helpful in managing their illness, and should not be stopped abruptly.
The FDA's warning, which will be reflected in the prescribing and package literature, makes clear that healthcare providers who are providing prenatal or psychiatric care for pregnant women should know that the use of antipsychotics in pregnancy raises the likelihood of EPS in newborns.
Women who are taking antipsychotic medication and become pregnant should discuss the decision to continue their medications or to discontinue them, and the pros and cons of their decision, with their healthcare providers.
The FDA update applies to all antipsychotic medications, both the conventional antipsychotics and the newer generation of medications.
Covered medications include Abilify, Clozaril, FazaClo ODT, Fanapt, Geodon, Haldol, Invega and Invega Sustena, Loxitane.
Moban, Navane, Orap,Risperdal, Risperdal Consta, Saphris, Seroquel; Seroquel XR, Stelazine,Thorazine, Zyprexa, Zyprexa Relprev, Zyprexa Zydis, and Symbyax.