FDA cuestiona uso de antidepresivos en el embarazo, pero médicos dicen que son esenciales

If you are pregnant or a new mother and are suffering from depression or anxiety, you can call or text the National Maternal Mental Health Hotline, available 24/7: 833-TLC-MAMA (833-852-6262). Postpartum Support International can help you find a local mental health provider at 800-944-4773 or psidirectory.com.

Before the birth of her second child, Heidi DiLorenzo experienced anxiety. She was concerned about her blood pressure and preeclampsia, which led to her being hospitalized twice during her pregnancy. She was upset that something terrible and uncertain would happen to her three-year-old daughter. She worried that she would not be able to love her second child as much as her first.

But DiLorenzo, a lawyer in Birmingham, Alabama, wasn't worried about taking Zoloft. She was already using this medication for anxiety before the birth of her first child and continued to take it during this pregnancy as well as her last pregnancy.

Since giving birth to her second daughter in September, she credits a higher dose of medication with helping her get out of the “dark pit” of sadness she found herself in after giving birth. “I wouldn't be such a good mother to my girls if I didn't accept this,” she said. “I wouldn’t have the strength.”

DiLorenzo is one of the approximately 20% of women in the United States who you have depression or anxiety during or after pregnancy.

However, only half of them receive adequate treatment, according to Kay Roussos-Rosswho directs the Perinatal Mood Disorders Program at the University of Florida. And only 5% take selective serotonin reuptake inhibitors (SSRIs), a class of drugs commonly used to treat both conditions.

Medical experts are now concerned that a roundtable convened in July by the Food and Drug Administration (FDA) could lead to an increase in cases of untreated depression.

Many of the 10 panel members expressed concerns about the use of SSRIs such as Zoloft during pregnancy. Among them were Josef Witt-Derring, a psychiatrist whose clinics help people get off antidepressants, and Adam Urato, an obstetrician-gynecologist who recently asked the FDA to place stronger warnings on the drugs.

Although the discussion did not constitute official FDA guidance, the panelists in statements that the American College of Obstetricians and Gynecologists (ACOG) called “extravagant and unreasonable”— have linked these drugs to an increased risk of miscarriage, birth defects and autism in children exposed during pregnancy.

The Society of Maternal-Fetal Medicine said its members were “dismayed unfounded and false claims FDA commission members.”

Antidepressants are a safe and “life-saving” tool given that mental health issues such as suicide and overdose are the leading causes of maternal death in the country, ACOG President Steven Fleischman said in a statement on the organization's website.

Kristena Rainesnurse practitioner who helped find first psychiatric department The nation's perinatal hospital in North Carolina said SSRIs are “probably the most studied medications during pregnancy.”

In long-term studies of children exposed to these drugs in utero, researchers found no problems, he said.

It's too early to tell whether this discussion has affected drug prescription rates or whether pregnant women are becoming more avoidant of these medications.

But Raines, who teaches at the University of North Carolina School of Medicine at Chapel Hill, says he's already fielding questions from his patients. He noted that the misinformation spread by the participants in the discussion, as well as distorted statements President Donald Trump about taking Tylenol during pregnancy is making their job harder.

Dorothy DeGuzman, a family medicine physician who treats high-risk pregnancies in California, said, “There is already a lot of stigma around using antidepressants during pregnancy. This will only increase the fear.”

Panel

The July discussion was one of four roundtables the FDA has held since May. In the past, the agency has carefully vetted members of its advisory committees to avoid conflicts of interest.

However, these groups were selected privately and the activities were conducted with little public outreach. A MedPage Today Study A paper published in July called into question the ethics and legality of the tables, according to researchers and consultants.

Emily Hilliard, a spokeswoman for the Department of Health and Human Services (HHS), did not respond directly about the panel's selection process. The events are round tables where experts review the latest scientific evidence, assess potential health risks and “explore safer alternatives,” he said.

The July Commission seemed to respond to executive order which Trump issued in February to create the Make America Healthy Again commission and task it with “evaluating the prevalence and risks of the use of selective serotonin reuptake inhibitors” and other drugs.

Kellyn Haight plans to continue taking Zoloft during her next pregnancy. “I'm willing to take risks because I know what the alternative is and I don't want to go back to that,” she said.(Katie Lynskey Shaw for KFF Health News)

Secretary of Health and Human Services Robert F. Kennedy Jr., who oversees the FDA, often criticizes these drugs. He stated:without evidence— this could have contributed to the school shooting.

In his opening remarks at the July meeting, FDA Commissioner Marty Macari also raised concerns about the drugs. “From a national perspective, the more antidepressants we prescribe, the more depression there is,” he said.

“This is not luxury”

The panel's sole member, board-certified psychiatrist and obstetrician-gynecologist Kay Roussos-Ross of the University of Florida, expressed different concerns. “Research shows that women who stop taking medications during pregnancy are five times more likely to relapse,” she said.

She added that mothers with moderate to severe depression or anxiety during pregnancy have a higher risk preterm birth and low birth weight babies. If they do not receive treatment, they are more likely use drugs or alcohol and be at risk of suicide.

They may also have difficulties create link with their children, which increases the risk that children will face problems such as attention deficit hyperactivity disorderdepression or anxiety is not due to the SSRIs, but due to maternal mental health problems.

“I want to emphasize that mental health treatment during pregnancy is not a luxury,” she told the panelists. “It's a necessity.”

Overall, about 19% of U.S. women ages 20 to 30 have depression, and about 10% are taking SSRIs, according to the latest data from the Centers for Disease Control and Prevention (CDC).

But research shows that half of women stop taking antidepressants before or during pregnancy.

One reason so few pregnant women get treatment for depression is because they are already afraid to take any medications during pregnancy, doctors say.

Most of DeGuzman's patients are beneficiaries of Medicaid, a health insurance program for people with low incomes or disabilities. Half are Hispanic. Although she often prescribes SSRIs, she says her patients rarely take them.

This issue is especially relevant for non-Hispanic black and Hispanic mothers who experience higher levels of depression and anxiety than non-Hispanic white women, but less likely to receive appropriate treatment. Factors contributing to these disparities include systemic racism, exposure to violence, misdiagnosis, and lack of access to health care.

Photo of Kellyn Haight and her daughter sitting by a shed outside.
Haight and his daughter at their home in Brevard, North Carolina.(Katie Lynskey Shaw for KFF Health News)

Shanna Williams, a perinatal therapist who serves African-American mothers in Philadelphia, said many of her patients already tend to rely more on family and friends than on doctors to decide whether it's safe to take antidepressants while pregnant or breastfeeding.

The FDA panel is “another voice saying they shouldn't do this,” he said. – And it doesn't help.

Judith Blancwho studies the perinatal mental health of women of color, said universal access to child care and paid maternity leave would be a big help. “My research has shown that the most important thing we can offer is social support,” said Blanc, an assistant professor of psychiatry at the University of Miami Miller School of Medicine. “We need the community to act.”

Kellyn Haight experienced debilitating depression after moving to the mountain town of Brevard, North Carolina. This former obstetrics nurse had no care for her two-year-old daughter and no family or close friends while her husband was away at work.

Her doctor prescribed Prozac, but it didn't help her. She called her husband at home, but her insomnia worsened. One morning he begged her to end his suffering. Her husband took her to the emergency room, where she was transferred to the psychiatric ward of a local hospital. There, she said, her clothes were taken off and she was placed in a closed room. “I felt like an animal,” said Haight, now 37. “One of my biggest fears is that this will happen again.”

After leaving the hospital, Haight saw a psychiatrist and began taking Zoloft. He made friends and began to feel stable.

Now that her daughter is 5 years old, she is trying to have another child and plans to continue taking Zoloft throughout her pregnancy. “I prefer to be safe and close to my daughter,” she said. “I’m willing to take risks because I know what the alternative looks like and I don’t want to go back to that.”

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