Fluoxetine HCl (Prozac) Therapy in Late Pregnancy Linked to Newborn Risk for
Persistent Pulmonary Hypertension
On March 15, the FDA approved safety labeling revisions for fluoxetine HCl
capsules/oral solution and delayed-release capsules (Prozac and Prozac
Weekly; Eli Lilly & Co) to warn of potential risks associated with both
continuation and discontinuation of fluoxetine HCl therapy during pregnancy.
Data from a retrospective case-control study of 1213 women suggest that
continued use of fluoxetine HCl and other selective serotonin reuptake
inhibitors past the 20th week of pregnancy is linked to a 6-fold increased
risk for persistent pulmonary hypertension in newborns. Persistent pulmonary
hypertension normally occurs in 1 or 2 newborns per 1000 births and often
involves severe respiratory tract failure requiring immediate treatment.
The FDA notes that although the study was too small to compare individual
drugs and the risk thus far has not been investigated by other studies, the
potential risk for persistent pulmonary hypertension adds to growing
concerns regarding use of selective serotonin reuptake inhibitors during
Newborn adverse events previously reported in association with prenatal
exposure include irritability, difficulty feeding, and rare cases of
difficulty breathing. In addition, use of fluoxetine HCl during the first
trimester has been epidemiologically linked to an increased risk for cardiac
Women receiving antidepressant therapy who are pregnant or considering
becoming pregnant should consult with their healthcare professional prior to
discontinuing or continuing antidepressant therapy. Such a decision should
be made only after careful consideration of individual treatment-related
risks and benefits.
The FDA notes that patients who elect to discontinue selective serotonin
reuptake inhibitor therapy should be closely monitored for depression
relapse. According to results from a prospective longitudinal study of 201
women, those who discontinue antidepressant therapy are 5 times more likely
to have a relapse during pregnancy compared with those who continue
Fluoxetine HCl capsules and oral solution are indicated for the treatment of
major depressive disorder, obsessive-compulsive disorder, panic disorder,
and bulimia nervosa.