In a recent Public Health Advisory, FDA summarized two new studies that practitioners should consider when making decisions about prescribing SSRIs and other antidepressant medications for pregnant women and those planning a pregnancy.
The first study followed pregnant women with a history of depression who had been taking antidepressants before they got pregnant. Those who stopped their medications were five times more likely to experience a relapse of depression during their pregnancy than those who continued to take the drugs. FDA's Advisory recommends that women who are pregnant or considering pregnancy not discontinue their antidepressants without consulting their physician. If the medication is stopped, patients should be monitored closely for signs of a relapse.
The second study found that infants born to women who had taken SSRIs after the 20th week of pregnancy experienced a sixfold increase in the risk of persistent pulmonary hypertension of the newborn (PPHN). PPHN is a life-threatening condition that becomes evident soon after birth and occurs in one to two per thousand births in the U.S. Infants with PPHN become hypoxemic because of abnormal blood flow through the heart and lungs.
These two studies underscore the need to weigh the risk of relapse in a pregnant woman who discontinues her antidepressant medication against the risk of rare but serious adverse effects in her infant if she continues to take the drug.
FDA Patient Safety News: November 2006
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=57#1In a recent Public Health Advisory, FDA summarized two new studies that practitioners should consider when making decisions about prescribin...all »In a recent Public Health Advisory, FDA summarized two new studies that practitioners should consider when making decisions about prescribing SSRIs and other antidepressant medications for pregnant women and those planning a pregnancy.
The first study followed pregnant women with a history of depression who had been taking antidepressants before they got pregnant. Those who stopped their medications were five times more likely to experience a relapse of depression during their pregnancy than those who continued to take the drugs. FDA's Advisory recommends that women who are pregnant or considering pregnancy not discontinue their antidepressants without consulting their physician. If the medication is stopped, patients should be monitored closely for signs of a relapse.
The second study found that infants born to women who had taken SSRIs after the 20th week of pregnancy experienced a sixfold increase in the risk of persistent pulmonary hypertension of the newborn (PPHN). PPHN is a life-threatening condition that becomes evident soon after birth and occurs in one to two per thousand births in the U.S. Infants with PPHN become hypoxemic because of abnormal blood flow through the heart and lungs.
These two studies underscore the need to weigh the risk of relapse in a pregnant woman who discontinues her antidepressant medication against the risk of rare but serious adverse effects in her infant if she continues to take the drug.
FDA Patient Safety News: November 2006
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=57#1«
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