Prozac Pregnancy Side Effects: It may cause pulmonary hypertension in babies: Pregnant women who are depressed may want to weigh the benefits of taking antidepressants against the possible, although inconclusive, risks to their developing fetuses.
Findings of a recent Nordic study published in the British Medical Journal found that newborn babies of women who take certain antidepressants are more likely to have pulmonary hypertension—or dangerously high blood pressure in their lungs.
The condition makes the babies unable to adapt to breathing on their own and can lead to organ failure and brain damage. About 11 percent of newborns diagnosed with pulmonary hypertension—known to doctors as persistent pulmonary hypertension of the newborn (PPHN)—will die from it, according to the American Academy of Pediatrics (AAP).
In general, one in every 1,000 babies born develops pulmonary hypertension, the group says. But women who, during pregnancy, took serotonin reuptake inhibitors (SSRIs)—commonly known by their brand names Prozac, Zoloft, Paxil, and Celexa and Lexapro—were twice as like to have babies with pulmonary hypertension compared with mothers who didn’t take SSRIs, the new study suggests.
SSRIs are one of the most-prescribed classes of antidepressants used to treat depression, anxiety disorders and some personality disorders. Some 1.5 percent of pregnant women in the United States take them.
The study, led by Helle Kieler at the Karolinska Institute’s Centre for Pharmacoepidemiology in Stockholm, looked at 1.6 million single births between 1996 and 2007 in Denmark, Finland, Iceland, Norway and Sweden.
The findings showed that newborn babies of some 17,000 mothers who filled out prescriptions for SSRIs before the eighth week of pregnancy had a slightly increased risk of having the condition—and the risk more than doubled for 11,000 expectant mothers who took the drugs after week 20 of their pregnancies.
The Karolinska Institute team said they also considered factors that have previously been associated with a baby’s development of PPHN: the mothers’ health conditions—obesity, diabetes or behaviors such as smoking—as well as the way the baby was delivered.
This translated to a fairly low absolute risk of about three in every 1,000 or 0.2 percent, the researchers noted. Still, doctors treating depression in pregnant woman may want to consider a non-drug approach to the condition, Kieler advised.
“As the risk in association with treatment in late pregnancy seems to be more than doubled, we recommend caution when treating pregnant women with SSRIs,” the researchers concluded.
The drugs analyzed included fluoxetine (Prozac, Sarafem, Symbyax), citalopram (Celexa), paroxetine (Paxil, Paxil CR, Pexeva), sertraline (Zoloft), fluvoxamine (Luvox, Luvox CR) and escitalopram (Lexapro). Vilazodone (Viibryd) is another SSRI, but it was not included in the analysis done by the Nordic researchers.
Risks of untreated depression
Meanwhile, if left untreated, depression during pregnancy also poses risks—not only to the depressed mother, but also to her child.
Health experts note that most women who stop medication during pregnancy relapse into depression. And previous studies suggest that untreated depression can raise the risk of premature delivery and low birth weight.
“This risk is not small and therefore outweighs the risk of persistent pulmonary hypertension,” the Agence France Presse quotes Dr. Jennifer Payne as saying. Dr. Payne is the director of the Johns Hopkins School of Medicine’s Women’s Mood Disorders Center.
Dr. Marjorie Greenfield, division director of obstetrics and gynecology at University Hospitals Case Medical Center in Cleveland points out that some depressed pregnant women are able to function without medication during pregnancy, Greenfield said. These women could steer clear of medications and consider alternatives such as talk therapy.
“There’s risk to having unmedicated depression as well as risk for treating depression. There needs to be good communication with moms about weighing risks and benefits,” she said.
FDA revises warning
In December 2011, the U.S. Food and Drug Administration advised physicians to continue treating mothers with antidepressants—a change in the position it held for five years.
The agency said it was revising its position because its initial warning in July 2006 on this potential risk was based on a single published study. “Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN,” the agency said.
The agency issued its first warning about the potential link between SSRIs and pulmonary hypertension in July 2006, following a study published in the New England Journal of Medicine that suggested pulmonary hypertension was six times more common in babies whose mothers took antidepressants after their second trimester than in babies whose mothers did not take an antidepressant.
“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 said in December safety announcement.
The FDA also noted, “It is well documented in the medical literature that SSRIs are used during pregnancy. In general, most epidemiology studies show that adverse events in pregnant patients are similar to those in non-pregnant patients, and many studies find no major fetal abnormalities in excess of the one to three percent found in the general population.
For pregnant women, the FDA has this advice:
If you are pregnant or plan to become pregnant, talk with your healthcare professional if you are depressed or undergoing treatment for depression to determine your best treatment option during pregnancy.
Talk to your healthcare professional about the potential benefits and risks of taking an SSRI during pregnancy.
Do not stop taking an SSRI antidepressant without first talking to your healthcare professional. Stopping an SSRI antidepressant suddenly may cause unwanted side effects or a relapse of depression.
Report any suspected side effects of SSRI use in pregnancy to your healthcare professional and to the FDA MedWatch program at 1-800-332-1088 or on its webpage.