Antidepressants During Pregnancy

The Babble Staff

The full effects of second-generation antidepressants such as Prozac and Zoloft on pregnant women and their children are unknown. Specialists say different risks are involved at the various stages of pregnancy, and few thorough studies have been done on how hormonal changes affect the way drugs are metabolized. Some studies maintain that the risks are negligible, while others indicate withdrawal symptoms in newborns and increased chances of low birth weight and preterm labor. The hormonal changes of pregnancy leave depression-prone women vulnerable. To some medical experts, the risks of taking a depressed woman off medication during pregnancy outweigh potential side effects to her fetus. Other doctors urge caution, claiming that any drug use during pregnancy is potentially harmful and that little is known about the long-term effects of antidepressants on child development. Others advocate holistic alternatives, ranging from light therapy to diet supplements. However, experts agree that women should talk to their doctors before embarking on any therapies, holistic or otherwise.

Women who take antidepressants during pregnancy have no more risk of having a baby with birth defects than women who don't take the drugs, according to a study.

The use of antidepressants from a class known as selective serotonin reuptake inhibitors (SSRIs) during pregnancy did not increase the risk of congenital malformations, low birth weight or preterm labor, researchers said.

Previous studies have found that SSRIs might increase the risk of early labor, however the current study found no such association.

Three of the women taking Prozac at relatively high doses did have low birth weight babies, however. Researchers say this may have been a result of the women's depression rather than the drug.

There have also been reports of complications in newborns such as jitteriness and rapid breathing associated with antidepressant use during pregnancy, which researchers say need to be further investigated.

Based on the study's results, researchers concluded that pregnant women should minimize their use of antidepressants when possible and opt for other options such as psychotherapy and group support.

From "Fluoxetine (Prozac) and Pregnancy, Birth Outcomes in Pregnant Women Taking Fluoxetine"

Many women are taking the drug fluoxetine (Prozac) either when they fall pregnant or while they are trying for pregnancy. There is some research into the outcomes of pregnancies in women who are using this common anti-depressant. There are two concerns with regard to pregnancy and Prozac — firstly whether its use in the first trimester is associated with any risk to the developing fetus — is there an increased risk of congenital abnormalities? Secondly, does it affect the outcome of the pregnancy or the subsequent development of the fetus?

There is no evidence that first trimester use of fluoxetine leads to higher rates of pregnancy loss or increased risk of fetal abnormality. There is consistency among the animal and human studies and significant numbers have now been accrued (about 1,000 first trimester exposures in all).

In 1996, a study was published that suggested worse outcomes for the babies of women who continued fluoxetine usage during the last trimester of pregnancy [3]. They included 73 exposed infants and found higher rates of early delivery, smaller babies, increased risk of breathing problems and feeding difficulties, and more admissions to the neonatal intensive care unit.

There is further reassurance from two other studies which find no increase in problems when fluoxetine is continued into the third trimester.

Women who take the popular antidepressant Prozac while pregnant might negatively affect the development of their babies.

Researchers found some of the consequences included babies that were born lighter and sleepier than normal. Respiratory problems were another reported consequence. A report revealed that the effects of taking the drug were more likely to happen in utero exposure during the late stages in gestation.

The report involved the study of Prozac, known generically as fluoxetine. Although the studied toxicity of this drug was considered to be reversible, long-term studies have yet to be performed to observe residual effects.

Experts also found that Prozac could affect sex drive in both adult men and women, and it was discovered that the drug was getting into the blood of newborns through breast milk. It was also reported that mood disorders in women of childbearing years was common and statistics showed that 15.6 percent of women met the qualifications for major depression while in their third trimester of pregnancy.

Researchers suggested further examination of how and why antidepressants could trigger the production of new brain cells, which could affect a fetus or newborn in ways that haven't yet been explored.

There are no definitive answers about the long-term effects of Zoloft and many other medications on babies. Experts say that while they have certainly learned some useful information for successful drug treatment in pregnancy, their knowledge is limited for the most part. That goes for information in the literature and on the labels doctors use to make clinical decisions, says Beth Conover, a genetic counselor who coordinates the Teratogen Information Service at the University of Nebraska Medical Center. "Teratogen" is a term that refers to any substance with the potential to cause birth defects.

Conover says advising patients and doctors about medication use in pregnancy is like working in shades of gray. "Parents want someone to assure them their babies will be OK, and of course that's what we want to do," she says. "But it's very hard to prove absolute safety. We would need extensive, long-term studies to do that, and we don't have them in many cases."

Dianne Kennedy, a regulatory health project manager with the Food and Drug Administration's Center for Drug Evaluation and Research (CDER), says withholding all medication during pregnancy is not the answer. Too many conditions pose more of a health risk if left untreated, she adds (see "The Danger of Untreated Disease"). In fact, medication use in pregnancy is common, and the number of prescriptions tends to rise with the mother's age. "We use the safest, best drugs we can so women can receive the treatment they need," Conover says.

The FDA has taken several steps to improve doctors' ability to give pregnant women safe and effective drug treatments. For example, the FDA regularly trains its reviewers in translating reproductive studies in animals into health risks for humans. The agency has also drafted a guidance document for industry on establishing pregnancy registries. Sponsored mostly by pharmaceutical companies, these studies identify women using certain drugs and then observe pregnancy outcomes.

In addition to general questions about safety, almost no information is available to help doctors know what the best dose of a particular medicine is for pregnant women. Changes in the body's physiology during pregnancy have the potential to require that doses be increased or decreased.

Zoloft's product labeling indicates that there are no well-controlled studies on the drug in pregnant women, that the effect of Zoloft on labor and delivery in humans is unknown, and that it also isn't known whether, or in what amount, the drug is excreted in human milk.

Unless research focuses on a pregnancy-related condition such as labor induction, drugs typically aren't studied in pregnant women because of the fear of exposing the woman to an experimental drug and harming the fetus.

The FDA is also working with the Centers for Disease Control and Prevention (CDC) on strategies for more comprehensive data collection. "CDC has birth defects surveillance, FDA has spontaneous event reports, some companies conduct pregnancy registries, and clinicians are seeing their own cases," Kweder says. "But there is no way yet that we can systematically bring all of this together, and that's the direction we need to go."

Taking the popular antidepressant drug Prozac late in pregnancy may be toxic to the fetus, a government report shows.

Mothers who take Prozac during the third trimester of pregnancy risk premature delivery, the report says. They also put their infants at risk of "poor neonatal adaptation."

Prozac taken by breastfeeding mothers, the report says, may retard infants' early growth.

These aren't Prozac's only effects on reproduction. The report also says that the antidepressant also has "reproductive toxicity." Adults taking the drug may find sexual orgasm difficult or impossible. And some women taking the drug may have changes in the length of their menstrual cycle.

"Patients should be aware that these are the risks of taking Prozac," Hines tells WebMD. "They really should talk with their doctors about them before going on the drug."

Tarra Ryker, spokeswoman for Prozac maker Eli Lilly & Co., says that the risks of untreated depression far outweigh those of properly prescribed antidepressants. Lilly is a WebMD sponsor.

"We don't believe there is sufficient evidence to conclude that Prozac is a developmental or a reproductive toxin," Ryker tells WebMD.

"There may be some side effects that cannot be avoided, but the benefits of this drug may be so great they outweigh the risks," Hines says.

"The main benefit is it is preventing depression at a vulnerable time in a vulnerable person," Levy tells WebMD. "Prozac can be helpful in warding off postnatal depression, which is bad for a woman and bad for her baby."

"If women stop antidepressant treatment during pregnancy, their risk for recurrence of their underlying depression is very, very high," Cohen tells WebMD. "And depression during pregnancy is associated with bad outcomes for newborns and very bad outcomes for women."

Hines, Cohen, Levy, and Ryker agree that pregnant women -- or women planning to become pregnant -- should not stop taking Prozac or other antidepressants until they've talked it over with their doctors.

Hines disagrees. [...] the panel members find the evidence disturbing enough to recommend caution.

"We think that there is some concern," Hines says. "We don't think these toxicities are life threatening, but we feel that to be one hundred percent confident in the safety of this drug, it would be good to have more studies done."

The panel concluded its report by recommending that more human and animal studies look closely at the effects of Prozac and other antidepressants on reproduction and child development.

"We found that the risk for relapse of depression is indeed very high during pregnancy," Cohen says. "I worry about pregnant women who have a history of depression and who stumble across this CERHR report. I worry that this huge effort on the part of CERHR will actually not help with the clinical care of patients."

From "Antidepressants in pregnancy may pose risks," by Alana Semuels

Pregnant women who take antidepressants such as Prozac and Paxil may be increasing the chances that their babies suffer from irritability, tremors and seizures at birth.

But while the babies of women who took antidepressants in the third trimester of pregnancy were three times more likely to have these symptoms than other babies, the effects were not found to last more than a few weeks, doctors at the University of Pittsburgh School of Medicine report in today's issue of the Journal of the American Medical Association.

Pregnant women with depression can be treated in a few different ways, including psychotherapy. Pharmaceutical solutions include a type of antidepressants called selective serotonin reuptake inhibitors, or SSRIs, which include Prozac, Paxil and Zoloft; and a type called serotonin/norepinephrine reuptake inhbitiors, or SNRIs, such as Effexor. This study looked at women taking both classes of medication; both types appear to affect babies.

Babies may be irritable because they are experiencing withdrawal — basically going "cold turkey" off a drug that they've been receiving through a mother's placenta, said Moses-Kolko. The symptoms may also be due to the toxicity of the drugs, some of which stay in the system; a baby's enzymes are not developed enough to purge the system of them quickly.

The most severe symptoms found in the literature review included seizures, vomiting and difficultly breathing; in one case, a baby needed to be intubated. Usually, the babies suffered only short-term, mild effects such as difficulty feeding and sleeping, irritability, and prolonged crying. Little conclusive research is available on how antidepressants affect newborns

"We can't assume that there's no adverse effects," said Sandy Zeskind, a research professor in pediatrics at the University of North Carolina-Chapel Hill. He believes that there are longer-lasting effects than those that can be explained by withdrawal.

Babies who were prenatally exposed to SSRIs had adverse effects on their central and autonomic nervous systems, according his research, which he presented on Monday at the Pediatric Academic Societies' annual meeting.

Only one drug has been approved by the FDA for use during pregnancy for any condition, said Einarson, and it alleviates the symptoms of morning sickness. This means that for whatever else ails her, a woman who takes medicine during pregnancy might be taking some risk.

From "Pregnancy and the Drug Dilemma," by Michelle Meadows

There are no definitive answers about the long-term effects of Zoloft and many other medications on babies. Experts say that while they have certainly learned some useful information for successful drug treatment in pregnancy, their knowledge is limited for the most part. That goes for information in the literature and on the labels doctors use to make clinical decisions, says Beth Conover, a genetic counselor who coordinates the Teratogen Information Service at the University of Nebraska Medical Center. "Teratogen" is a term that refers to any substance with the potential to cause birth defects.

Conover says advising patients and doctors about medication use in pregnancy is like working in shades of gray. "Parents want someone to assure them their babies will be OK, and of course that's what we want to do," she says. "But it's very hard to prove absolute safety. We would need extensive, long-term studies to do that, and we don't have them in many cases."

Dianne Kennedy, a regulatory health project manager with the Food and Drug Administration's Center for Drug Evaluation and Research (CDER), says withholding all medication during pregnancy is not the answer. Too many conditions pose more of a health risk if left untreated, she adds (see "The Danger of Untreated Disease"). In fact, medication use in pregnancy is common, and the number of prescriptions tends to rise with the mother's age. "We use the safest, best drugs we can so women can receive the treatment they need," Conover says.

The FDA has taken several steps to improve doctors' ability to give pregnant women safe and effective drug treatments. For example, the FDA regularly trains its reviewers in translating reproductive studies in animals into health risks for humans. The agency has also drafted a guidance document for industry on establishing pregnancy registries. Sponsored mostly by pharmaceutical companies, these studies identify women using certain drugs and then observe pregnancy outcomes.

In addition to general questions about safety, almost no information is available to help doctors know what the best dose of a particular medicine is for pregnant women. Changes in the body's physiology during pregnancy have the potential to require that doses be increased or decreased.

Zoloft's product labeling indicates that there are no well-controlled studies on the drug in pregnant women, that the effect of Zoloft on labor and delivery in humans is unknown, and that it also isn't known whether, or in what amount, the drug is excreted in human milk.

Unless research focuses on a pregnancy-related condition such as labor induction, drugs typically aren't studied in pregnant women because of the fear of exposing the woman to an experimental drug and harming the fetus.

The FDA is also working with the Centers for Disease Control and Prevention (CDC) on strategies for more comprehensive data collection. "CDC has birth defects surveillance, FDA has spontaneous event reports, some companies conduct pregnancy registries, and clinicians are seeing their own cases," Kweder says. "But there is no way yet that we can systematically bring all of this together, and that's the direction we need to go."