Information about the potential risks for extrapyramidal and withdrawal symptoms in newborns exposed in utero to antipsychotics in the third trimester is being added to the prescribing information of all antipsychotics, the Food and Drug Administration announced on Feb. 22.
These symptoms "may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding," which in some infants "may subside within hours or days and do not require specific treatment," according to the statement posted on the FDA’s MedWatch site. However, other newborns with these symptoms might need to be hospitalized for a longer period, the statement adds.
These were among the symptoms that have been reported to the FDA’s Adverse Event Reporting System (AERS) in newborns born to mothers who had taken antipsychotics – which cross the placenta – during pregnancy. A search of the AERS database through Oct. 29, 2008, identified 69 cases of neonatal extrapyramidal symptoms (EPS) or withdrawal associated with different antipsychotics, with symptoms that varied in severity. Some babies recovered within hours or days without any specific treatment "while others required intensive care unit support and prolonged hospitalization," the statement said. Symptoms appeared anywhere from birth through age 1 month, according to those cases that included information about the timing of the symptoms.
Phenobarbital and benzodiazepines were among the treatments used for these symptoms. Blood levels of the drugs were not available, so it was not possible to determine whether symptoms were attributable to drug toxicity or withdrawal – and most of the 69 cases were confounded by other factors, which included concomitant use of other drugs known to be associated with withdrawal symptoms, prematurity, congenital malformations, and obstetric and perinatal complications. But some cases also suggested "neonatal EPS and withdrawal may occur with antipsychotics alone," the statement added.
The FDA recommends that newborns who have been exposed to antipsychotics and show signs of EPS or withdrawal should be monitored.
The information is being added to the pregnancy section of the labels for the entire class of antipsychotics, used to treat schizophrenia and bipolar disorder, which includes drugs such as haloperidol and chlorpromazine that have been available for decades, as well as the newer atypicals, such as aripiprazole, olanzapine, and ziprasidone.
The MedWatch report includes a section for patients, advising them not to stop taking antipsychotics if they become pregnant, without consulting their health care professionals.
Adverse events related to the use of these products should be reported to the FDA online or at 800-332-1088.