Antipsychotics During Pregnancy May Cause Problems for Newborns: FDA

Federal drug regulators indicate that new warnings will be added to antipsychotic medications about a risk of movement problems and withdrawal symptoms for newborns when the drugs are used by pregnant women.

On February 22, the FDA issued a safety alert, announcing that new label warnings would be required for old and new antipsychotic drugs including Seroquel, Zyprexa, Risperdal, Geodon, Invega and Abilify, among others.

The new warnings will alert doctors and patients to the risk of abnormal muscle movements known as extrapyramidal signs (EPS) and drug withdrawal symptoms in newborns whose mothers took an antipsychotic during the third trimester.

The FDA has identified at least 69 cases of neonatal EPS linked to antipsychotic drugs through adverse event reports filed by health care professionals and patients. The onset of symptoms seem to appear from birth to one month after birth and include agitation, abnormal muscle tone (increased or decreased), tremors, sleepiness, severe difficulty breathing and difficulty eating. In some cases the symptoms disappear within hours without treatment, but in other cases they can cause prolonged hospital stays for the newborn.

Antipsychotics are a broad class of medication used to treat psychiatric problems such as bipolar disorder and schizophrenia, but they are also often used by doctors to treat a variety of off-label ailments that have not been approved by the FDA. The drugs are known to have the ability to cross the placenta and affect unborn children.

The FDA is advising healthcare professionals to be aware of the possible side effects of antipsychotics on newborns when used during pregnancy and that use during the third trimester can result in EPS. Doctors should advise patients regarding the benefits and risks of antipsychotics during pregnancy. If they know the mother was on antipsychotics in the third trimester they should monitor the newborn for signs of EPS or withdrawal.

Patients are being advised to notify their healthcare professional if they become pregnant or plan on becoming pregnant while on an antipsychotic. The FDA recommends that they not stop taking an antipsychotic medication when they discover they are pregnant until they have talked to their healthcare provider.

The new label warnings will apply to all antipsychotics. A full list of drugs affected is available on the FDA’s drug safety communication regarding the new label warnings.