The FDA stiffens warnings about atypical antipsychotics during pregnancy
The Food and Drug Administration on Monday said that it is strengthening the warning label on the family of drugs known as atypical antipsychotics to warn women about the danger to infants of using the drugs in the third trimester of pregnancy. The drugs, which are used to treat schizophrenia and bipolar disorder, include such well-known medications as Abilify, Geodon, Haldol, Risperdal, Seroquel and Zyprexa, as well as several lesser-known products. The agency said most doctors are already familiar with the potential problems, but that it wanted to make sure that the information is as widespread as possible.
The FDA said it had received 69 reports of problems with newborns linked to the drugs before Oct. 29, 2008, including withdrawal symptoms, abnormal muscle movements -- called extrapyramidal signs -- excessive sleepiness, tremor, respiratory distress and feeding disorders. Some of the infants recovered within hours or a few days, while others required prolonged hospitalization.
Experts said pregnant women or those who hope to become pregnant should not stop taking the drugs abruptly, as that could cause even more severe complications. Rather, they should consult their physicians to determine the best course of action.
The last change in the labeling of the drugs occurred in 2005, when the label was strengthened to warn that the medications increased the risk of dementia in older patients.
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