Israeli Study: One in 3 infants Suffer SSRI Withdrawal

The entire profession seems to be in the business of marketing antidepressants, encouraging rather than discouraging women–even as they cannot deny there are risks.  Headline news reports in the press and network TV (Feb. 1) announced: 

“Pregnant women who stop taking antidepressants run a high risk of slipping back into depression, a study found — dispelling a myth that the surge of hormones during pregnancy keeps mothers-to-be happy and glowing.”

Expanding on a study published in the Journal of the American Medial Association, two of whose authors declared conflicts of interest, Dr. Catherine Spong, of the National Institute of Child Health and Human Development, assured the public on CBS: "It’s important to look at what type of antidepressant is being used and when it’s being used during pregnancy. Although antidepressants generally are considered to be safe during pregnancy, some have been linked to complications, such as complications of the developing baby’s heart as well as the withdrawal syndrome that occurs after birth. These are, in general, very rare, though."

Throughout the years the profession has reassured women that taking antidepressants during pregnancy was preferable to being depressed. The  American Family Physician website:  http://www.aafp.org/afp/20041201/fpin.html

Minnesota Biomedical Library: http://www.biomed.lib.umn.edu/hmed/2000/10/20001001_dep.html announces: “Depression poses greater risks during pregnancy than Prozac doctors say.”

But then comes reality-based medicine with jolting evidence of harm to infants exposed to Paxil in utero. Reuters reports that a study in Israel found that: “Nearly one in three infants born to women taking anti-depressant drugs exhibit signs of withdrawal.” 

Withdrawal syndrome, which is acknowledged in the GSK Paxil (Seroxat) label in the UK, is not yet acknowledged in FDA-approved labels. It is an explosive Pandora’s box that haunts patients trying to stop taking SSRIs. Withdrawal syndrome demonstrates the addictive nature of SSRIs. 

Contact: Vera Hassner Sharav
veracare@ahrp.org

Reuters

Moms’ antidepressants hit third of newborns: study

Mon Feb 6, 4:03 PM ET

Nearly one in three infants born to women taking anti-depressant drugs exhibit signs of withdrawal and expectant mothers may want to limit the drugs they take, researchers said on Monday.

Symptoms such as high-pitched crying, tremors, gastrointestinal problems and disturbed sleep may show up in the first 48 hours after birth and were more pronounced in infants whose mothers had been taking higher doses.

A closer look at the 37 infants exposed in the womb to paroxetine hydrochloride, sold as Paxil by GlaxoSmithKline, showed the risk of symptoms disappeared if the mother’s dosage was less than 20 milligrams daily while the risk was highest among those exposed to 27 milligrams or more.

Thirty percent of the 60 newborns exposed to one of the popular class of drugs known as selective serotonin reuptake inhibitors (SSRIs) in the womb were found to have withdrawal symptoms and the symptoms were classified as severe in 13 percent, said the study by Dr. Rachel Levinson-Castiel of the Children’s Medical Center of Israel, in Petah Tiqwa.

Symptoms usually did not peak until after the first day of life but the long-term effects are not known, the study said.

Two of the exposed infants suffered seizures but they did not persist.
Previous studies into the effects of SSRIs on newborns have identified other symptoms such as rapid breathing, bluish skin color from lack of oxygen, feeding difficulties, low blood sugar and jitteriness.

Yet a study published last week by researchers at Massachusetts General Hospital in Boston said women who need an antidepressant cannot depend on hormonal changes in pregnancy to relieve their symptoms so may choose to continue taking the drug.

"Because maternal depression during pregnancy also entails a risk to the newborn, the risk-benefit ratio of continuing SSRI treatment should be assessed," Levinson-Castiel wrote in the journal Archives of Pediatrics and Adolescent Medicine.

Unfortunately, "the long-term effects of in utero exposure to SSRIs have not been demonstrated clearly," not even for those whose symptoms were severe early on, she wrote.

Both studies recommended pregnant women simplify their drug regimen to a single drug at the lowest effective dose. 
 

Anti-depressants ‘risk for newborns’

From correspondents in Chicago
07 February 2006

NEARLY one in three infants born to women taking anti-depressant drugs exhibited signs of withdrawal and expectant mothers might want to limit the drugs they take, researchers said today.

Symptoms such as high-pitched crying, tremors, gastrointestinal problems and disturbed sleep may show up in the first 48 hours after birth and were more pronounced in infants whose mothers had been taking higher doses.

A closer look at the 37 infants exposed in the womb to paroxetine hydrochloride, sold as Paxil by GlaxoSmithKline, showed the risk of symptoms disappeared if the mother’s dosage was less than 20 milligrams daily while the risk was highest among those exposed to 27 milligrams or more.

Thirty per cent of the 60 newborns exposed to one of the popular class of drugs known as selective serotonin reuptake inhibitors (SSRIs) in the womb were found to have withdrawal symptoms and the symptoms were classified as severe in 13 per cent, said the study by Dr Rachel Levinson-Castiel of the Children’s Medical Centre of Israel, in Petah Tiqwa.

Symptoms usually did not peak until after the first day of life but the long-term effects are not known, the study said.

Two of the exposed infants suffered seizures but they did not persist.
Previous studies into the effects of SSRIs on newborns have identified other symptoms such as rapid breathing, bluish skin colour from lack of oxygen, feeding difficulties, low blood sugar and jitteriness.

Yet a study published last week by researchers at Massachusetts General Hospital in Boston said women who need an antidepressant could not depend on hormonal changes in pregnancy to relieve their symptoms so might choose to continue taking the drug.

"Because maternal depression during pregnancy also entails a risk to the newborn, the risk-benefit ratio of continuing SSRI treatment should be assessed," Dr Levinson-Castiel wrote in the journal Archives of Pediatrics and Adolescent Medicine.

Unfortunately, "the long-term effects of in utero exposure to SSRIs have not been demonstrated clearly", not even for those whose symptoms were severe early on, she wrote.

Both studies recommended pregnant women simplify their drug regimen to a single drug at the lowest effective dose.

~~~~~~~~~~~~~

Depression A Risk During Pregnancy

MIAMI, Feb. 1, 2006
(CBS/AP) Pregnant women who stop taking antidepressants run a high risk of slipping back into depression, a study found dispelling a myth that the surge of hormones during pregnancy keeps mothers-to-be happy and glowing.

The study offers new information but no clear answers for expectant mothers who must balance the risk of medications harming the fetus against the danger of untreated depression.

"It’s important that patients not assume that the hormones of pregnancy are going to protect them from the types of problems they’ve had with mood previously," said Dr. Lee Cohen of Massachusetts General Hospital, one of the study’s co-authors.

Indeed, on The Early Show Wednesday, Dr. Catherine Spong, a pregnancy specialist with the National Institute for Child Health and Human Development, stressed that, "There’s been a growing body of evidence that suggests depression itself is very common during pregnancy."

The study does not deal with postpartum depression the depression that sets in after delivery and that is often blamed on hormonal changes. The research looks only at depression during pregnancy, a condition far less understood.

But, says Spong, "This study provides critical information for pregnant women with major depression.

"Even though it was previously thought that pregnancy protected against recurring episodes of depression, relapses continue to occur. This is vitally important for these women."

No one knows how many pregnant women are on antidepressants, but it’s safe to say millions of women of childbearing age take them. Medco Health Solutions estimates 8.4 million American women ages 20 to 44 take antidepressants.

Other research has shown risks to the fetus including possible heart defects from antidepressant use during pregnancy.

"Drugs rarely, if ever, are actually studied in pregnancy to determine whether they are safe," Spong observes. "It’s important to look at what type of antidepressant is being used and when it’s being used during pregnancy. Although antidepressants generally are considered to be safe during pregnancy, some have been linked to complications, such as complications of the developing baby’s heart as well as the withdrawal syndrome that occurs after birth. These are, in general, very rare, though."

Researchers followed 201 pregnant women with histories of major depression who were taking drugs such as Prozac, Zoloft, Effexor and Paxil.
Because of ethical concerns, the researchers did not randomly assign the women to either stop or continue medication. Instead, the women decided what to do; researchers then watched what happened.

Sixty-eight percent of those who stopped taking antidepressants slipped into depression. They were five times more likely to suffer a relapse than the women who continued on drugs.  But staying on antidepressants did not shield expectant mothers from depression entirely; 26 percent of those who continued drug treatment became depressed anyway.

Dr. Katherine Wisner of the University of Pittsburgh School of Medicine says the study makes an important contribution by quantifying the risk of relapse. She was not involved in the study but does similar work.  "I was taught in my residency that women don’t get depressed during pregnancy," says Wisner, who was a psychiatry resident in the early 1980s. But "I had patients who were depressed. I asked my supervisor, `You mean I’m really not seeing patients who are depressed?’"

The study appears in Wednesday’s Journal of the American Medical Association and was funded by the National Institute of Mental Health. Two of the co-authors declared in the paper that they have financial ties to several antidepressant manufacturers.

Other researchers have shown that antidepressant use during the last three months of pregnancy can make newborns jittery and irritable and can cause serious breathing problems. In addition, the Food and Drug Administration has warned that Paxil may be linked to fetal heart defects if a pregnant woman takes it during the first three months of pregnancy.

Dr. Peter Kramer, author of "Listening to Prozac" and "Against Depression," says the study provides information that can help women and doctors decide what to do.
"Ideally, everyone would like to go through pregnancy off all medication," Kramer says. "But these are serious issues, and both decisions can be justified."
Kramer suggested some women might want to get off antidepressants but schedule more psychotherapy while pregnant.

Spong says women "absolutely" shouldn’t immediately go off antidepressants if they learn they are pregnant: "As with any medication in pregnancy, it’s very important for her to talk with her doctor as to the risks and benefits of that medication. And a woman with major depression clearly needs close and careful monitoring, as relapses can occur during pregnancy."

©MMVI, CBS Broadcasting Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.

Antidepressants Safe During Pregnancy

By Pippa Wysong
The Medical Post, January 28, 1997

TORONTO – Women who suffer from depression may be cheered by news that it is safe to take antidepressants while pregnant.

After a follow-up study of children born to women taking antidepressants, researchers from the Hospital for Sick Children’s Motherisk program found nothing unusual in terms of I.Q., language or other psychological or behavioral measures.

Tricyclic antidepressants
The study focused on children born to mothers who had been taking tricyclic antidepressants or fluoxetine.
"Depression is common among women of reproductive age," said Dr. Gideon Koren, head of Motherisk and professor of pediatrics at the University of Toronto.

An estimated 8% to 20% of women get depressed at some point in their lives yet the messages about taking antidepressants during pregnancy have been mixed.

Some doctors advise against taking the medications and others say it is probably safe, he said.
Generally, drug-induced malformations are triggered during the first trimester of pregnancy. The brain, however, develops throughout the entire nine months and potentially can be injured after the first trimester.

Fluoxetine
Both tricyclics and fluoxetine cross the placenta, though animal studies have shown large doses of the drugs do not cause malformations.

Depression is not a mild problem and can have severe consequences. "Untreated, depression can lead to suicide attempts," he said.

There can be a real balancing act when weighing the risk to the mother of untreated depression versus the risk to the fetus from taking a drug, he said.

Since 1985, 129 pregnant women who were taking antidepressants have been counselled by Motherisk staff. Out of the group 80 who had given birth were available for follow-up.

Some of the initial group were excluded from the study because they had been taking other medications as well, declined to participate or had either spontaneous or therapeutic abortions.

Forty of the women had taken tricyclic antidepressants during the first trimester, 36 took antidepressants throughout the whole pregnancy, two took them during the first and second trimesters and two during the first and third only.

Antidepressants
There were 55 women who had taken fluoxetine, 37 of whom took the drug during the first trimester, and 18 throughout the pregnancy.

The offspring of these women were compared to 84 controls who were born to women who had not taken any antidepressants.

When compared to the controls, the women taking antidepressants consumed more alcohol and smoked more. Those on fluoxetine had more pregnancies, more previous therapeutic abortions and tended to be from a lower socioeconomic group than women in the other two groups.

The rate of major malformations was similar among all three groups with three occurring in the children who had been exposed to tricyclics in utero, two in those exposed to fluoxetine and two in the controls.

Psychological and behavior tests done on the children had similar results among the three groups. The children, who were between one-and-a-half and six years of age had similar results on I.Q. tests, language skills and behavioral development, Dr. Koren said.

The severity of the mother’s depression was taken into consideration in the analysis.
What was related to a negative result in terms of child development was a low socio-economic status. But this has been shown in other studies, he said.

Copyright © 1997 Maclean Hunter Publishing Limited
Reprinted with permission.

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