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.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.

1 Comments

  • jamieJuly 19, 2011 at 8:32 pm

    took seroquel entire pregnancy. baby showing signs of withdrawal but they don't want to consider it. no blood work just going by their test score???

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Management of Ozempic Lawsuit Pretrial Proceedings To Be Reassigned Following Death of MDL Judge
Management of Ozempic Lawsuit Pretrial Proceedings To Be Reassigned Following Death of MDL Judge (Posted 6 days ago)

The judge overseeing Ozempic lawsuits consolidated in federal court has died, requiring a new judge to be assigned to oversee coordinated pretrial proceedings over claims the diabetes drug and similar medications caused stomach paralysis and other intestinal complications.