A UCSD study released today is fueling concerns about the effects of certain antidepressant drugs on pregnant women, saying that their use late in pregnancy can significantly increase the chance of deadly lung problems in newborns.
Normally, the lung disorder is rare, with one to two per 1,000 births. But when pregnant women took the drugs in question after the 20th week of pregnancy, the incidence rose to six to 12 per 1,000 births, a report by Dr. Christina Chambers and colleagues at UC San Diego found.
The antidepressants that increased that risk are in a class called SSRIs or selective serotonin reuptake inhibitors. They include citalopram, fluoxetine, paroxetine and sertraline sold under 19 brand names, including Celexa, Prozac, Paxil and Zoloft.
Babies born with the lung disorder, persistent pulmonary hypertension or PPH, often require mechanical assistance to breathe. Between 10 percent and 20 percent will die soon after birth, while others will have developmental delays, hearing loss and brain abnormalities.
Chambers said she didn’t want pregnant women now taking the drugs to become scared.
“Ninety-nine women in 100 who take SSRIs late in pregnancy will not have a baby with PPH, so the risk is fairly low,” Chambers said. “But the risk is higher than if the women don’t take the drugs, so I think it’s important to get the information out there so health providers and women aren’t navigating in the dark.”
In a Washington news conference yesterday, a U.S. Food and Drug Administration official called Chambers’ findings significant and “worrisome,” especially because 10 percent to 15 percent of women of reproductive age have major depression and are the biggest users of antidepressant drugs.
Dr. Sandra Kweder, deputy director of the FDA’s Office of New Drugs, added that the report comes only a few weeks after a flurry of other large studies on other problems with antidepressants, particularly SSRIs.
Kweder said the FDA will issue a “public health advisory” in the next few days that may include a recommendation that manufacturers of antidepressant drugs conduct additional safety studies.
Women should not go off their antidepressants cold turkey, Kweder said.
“Don’t panic,” she said, adding that women with concerns should talk to their doctors. A decision about whether to stop taking the drugs should take into account the severity of the depressive symptoms that prompted the prescription.
“Stopping these medicines on your own can sometimes create more problems than it solves,” Kweder said. “Often these medicines are associated with withdrawal symptoms, which can be problematic for many patients.”
Recent reports have linked SSRIs and other antidepressants with problems in newborns such as not eating properly, jitters and seizures. One study published last week in The Archives of Pediatrics & Adolescent Medicine said 30 percent of infants exposed to SSRIs in the womb develop sugar imbalance, sleep disturbances and difficulty eating that show up like the symptoms of drug withdrawal.
In December, the FDA warned that the use of one SSRI, paroxetine sold as Paxil, during the first trimester is associated with increased risk of birth abnormalities such as cardiac defects.
Another study published last week in the Journal of the American Medical Association dispelled a previously held belief that hormonal and other biochemical changes in pregnant women somehow protected them from clinical depression.
Dr. Lee S. Cohen, a psychiatrist at Massachusetts General Hospital and lead author of the report, wrote that 68 percent of women who discontinued antidepressant treatment after getting pregnant had a significant relapse into depression before giving birth.
Published reports suggest that the use of antidepressants by pregnant women results in some negative impact for as many as 30 percent of their newborns, although most of the time the problems are short-lived and reversible.
“Most studies have not suggested a smoking gun for long-term problems with the use of SSRIs,” said Dr. James Mills, a researcher with the National Institute of Child Health and Human Development. “But that’s not true for PPH. In that group (of newborns) the story is very different” because PPH is so serious.
In Chambers’ study, the higher incidence of PPH did not occur in women who took non-SSRI antidepressants. These include tricyclics such as amitriptyline sold as Elavil, bupropion sold as Wellbutrin, venlafaxine sold as Effexor and trazodone sold as Desyrel.
The higher risk also was not seen in women who stopped taking SSRIs by the 20th week of pregnancy, her study found.
Asked if she she would take an SSRI if she were pregnant and depressed, Chambers said that it would depend on how depressed she was, what other coping mechanisms were available and whether she were given options for alternative medications.
She stressed that more research is needed to look further into the future for children exposed in the womb to antidepressants.
Chambers urged the FDA and drug companies to develop “better information about this group of antidepressants, and as it is developed it needs to be disseminated.”
The UCSD study, done with colleagues in Boston, Toronto and Philadelphia, is published in today’s New England Journal of Medicine. Participants were enrolled from more than 100 hospitals, including 17 in San Diego County.
As they read Chambers’ study, San Diego area psychiatrists yesterday said they were rethinking the way they prescribe this class of medication to patients who may be thinking of having children.
But sometimes they have no choice, they said, in the case of a patient who is severely depressed and for whom other categories of antidepressants don’t work.
“Sometimes there is no other way to help a woman who is in a severely restless and agitated state,” said Dr. Rodrigo Munoz, a psychiatrist and former president of the San Diego County Medical Society.
“No doubt giving the woman any medication during pregnancy is taking a risk.”
Mission Valley psychiatrist Dr. Catherine Moore said she takes into account how sick her patient is.
“Some women are so depressed, they’re not eating well, and that may have an effect on a baby’s low birth weight or cause developmental delays,” Moore said.
That absolutely needs to be taken into account, she said.
The FDA’s Kweder said the Chambers study, added to the others, “absolutely highlights the critical need for more and better information about the safety and best uses of drugs during pregnancy.
“What you’re seeing is that our society’s increasing reliance on pharmaceuticals is finally extending to pregnant women, but there’s a paucity of information designed to look at this in a systematic way,” Kweder said.