FDA Issues Information about Reported Paxil Side Effects

Washington, DCThe US Food and Drug Administration (FDA) has once again issued information about Paxil side effects and the side effects of similar antidepressants, although the new information says that studies about antidepressant use during pregnancy are contradictory. Some studies suggest an increased risk of Paxil birth defects and Paxil heart defects when expectant mothers use Paxil and other Selective Serotonin Reuptake Inhibitors (SSRIs) but others have not found such a link.

Back in July 2006, the FDA released a Public Health Advisory that the use of Paxil and other SSRI antidepressants during pregnancy was potentially linked to an increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN; formerly called Primary Pulmonary Hypertension of the Newborn). Persistent Pulmonary Hypertension of the Newborn is a serious birth defect in which the infant does not properly adapt to breathing after birth. Some newborns with PPHN experience extreme distress, including organ damage, brain damage and death.

That 2006 Public Health Advisory was based on information from one study, the FDA stated. On December 14, 2011, the FDA issued a new Drug Safety Communication, advising the public that newer studies have provided conflicting findings concerning the risk of PPHN in infants exposed to Paxil and other SSRIs prior to birth.

"FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN," the FDA stated. In making its announcement, the FDA reported that two studies suggest an increased risk of PPHN in pregnant women who use SSRI medications while three studies did not support that conclusion.

The FDA noted that there are no adequate and well-controlled studies of SSRIs in pregnant women, which makes it difficult to obtain reliable information. Of course, part of the problem with such studies is that they would require researchers to give pregnant women a medication that could potentially harm their infant, raising the problem of ethical issues with such studies.

Doctors and their patients are advised to weigh the small potential risk of using SSRIs during pregnancy with the risk of having untreated depression, which can result in poor birth outcomes, the FDA advises.