Editorial: In Utero Exposure to Antipsychotics

However, it should be appreciated that for many patients, the use of atypical antipsychotics across pregnancy may be required to sustain psychiatric well-being. In fact, the FDA does not recommend arbitrary discontinuation of these agents, but rather notes that health care professionals "should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy."

Clearly, given the nature of the psychiatric disorders for which these medicines are being used, the clinician needs to be particularly mindful that abrupt discontinuation of this class of medicines can increase the risk of recurrence of the underlying illness. Perhaps the most prudent clinical approach in this situation is one of careful observation – as opposed to arbitrary discontinuation of a typical or atypical antipsychotic, which is neither suggested nor implied in the FDA’s communication. The FDA communication, which is not a warning, presumably serves to provide extra data for the clinician to factor into risk-benefit decisions.

Clearly, only a prospective study with clear knowledge of exposure and concomitant drug therapy with prospective assessment of the exposed newborns will yield information that refines our knowledge of this signal, which the FDA has suggested may exist. Eligible patients for the MGH National Registry of Atypical Antipsychotics can enroll by calling 866-961-2388.