Use of Antidepressants While Pregnant Can Affect Baby

Spanish researchers find withdrawal symptoms

THURSDAY, Feb. 3, 2005 (HealthDay News) -- Women who take antidepressants like Paxil or Prozac while pregnant may have babies who experience withdrawal syndrome in the first few days of life, a new study finds.

Spanish scientists, using a worldwide drug alert system, found a higher-than-expected incidence of neonatal withdrawal syndrome, consisting of convulsions, irritability, abnormal crying and tremors, among babies of women who took selective serotonin reuptake inhibitors (SSRIs), the class of drugs that includes Paxil and Prozac.

Their report, which is published in the Feb. 5 issue of The Lancet, found the association seemed to be highest among women who used Paxil.

"There is an association in some cases, not in every single case," said Dr. Emilio Sanz, the lead author of the paper and a clinical pharmacology professor at the University of La Laguna School of Medicine in Tenerife. "If you have a pregnant woman that is depressed and is treated with anti-depressants, you should use the lowest effective dose or psychotherapy or other approaches if you can."

"Doctors should be more careful in prescribing SSRIs, especially paroxetine [Paxil] during pregnancy," added Dr. Vladislav Ruchkin, an associate research scientist at Yale University School of Medicine and the author of an accompanying editorial in the journal.

SSRIs, which first hit the market in 1988, are widely used to treat depression, anxiety and other mood and behavioral disorders in adults as well as children. But the drugs have been the subject of much recent controversy.

Reports last year of suicidal thinking in adolescents who use them led to a U.S. Food and Drug Administration review of clinical trials of antidepressants, which confirmed the association. That, in turn, led to the FDA's ordering a "black box" warning on the labels.

There has also been concern that SSRIs triggers manic behavior in 10 to 14 year olds, although a study released just this week found that the benefits of antidepressants appeared to outweigh the risk of suicide.

Several smaller studies, however, have already shown an increased risk of complications for pregnant women taking SSRIs.

For this latest research, investigators screened an international drug surveillance system maintained by the World Health Organization (WHO). The database contains three million records from 72 countries dating back to 1968. A signaling system sends alerts when there are more cases than there should be.

The investigators found a total of 93 cases of neonatal convulsions or withdrawal syndrome associated with SSRI use. About two thirds of the cases (64) were associated with Paxil, 14 with Prozac, nine with Zoloft and seven with Celexa, they said.

The database had incomplete information on dosage and duration of treatment and also doesn't include information on how many people were or are using these drugs.

Although those babies who experienced withdrawal syndrome appear to recover within a short period of time, Ruchkin is concerned that there may be a developmental impact on the infant brain, a subject on which there is little research.

"A number of studies suggest that SSRIs may have a long-term impact on the child's brain," he said, adding, however, that most such studies have been done with mice and that human studies need to be done.

For the moment, there is no clear guidance other than to exercise caution, Sanz said, with doctors assessing the severity of each woman's case before prescribing antidepressants.

More information

For more on this drug monitoring system, visit the World Health Organization.

SOURCES: Emilio Sanz, M.D., professor of clinical pharmacology, University of La Laguna School of Medicine, Tenerife, Spain; Vladislav Ruchkin, M.D., Ph.D., associate research scientist, Yale Child Study Center, Yale University School of Medicine, New Haven, Conn.; Feb. 5, 2005, The Lancet
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