Feb. 3, 2005 -- Women taking antidepressant drugs, such as Paxil, Prozac, Zoloft, and Celexa, may want to talk to their doctors about their medications if they're pregnant or planning to get pregnant.
There's a chance that such drugs -- called selective serotonin reuptake inhibitors (SSRIs) -- might cause withdrawal symptoms in babies born to women who took the drugs during pregnancy.
SSRIs have been in use since 1988. They were first introduced to treat depression. They're becoming "the gold standard of treatment for a wide spectrum of mood and behavioral disorders, say the researchers, who included professor Emilio Sanz, MD, of Spain's University of La Laguna.
Besides depression, SSRIs are used to treat "obsessive-compulsive disorder, panic disorder, social phobia, post-traumatic stress disorder, premenstrual dysphoric disorder, and generalized anxiety disorder," say the researchers in The Lancet's Feb. 5 issue.
But for all their success, the drugs are not without controversy. Last October, the FDA ordered all antidepressant drugs -- including SSRIs -- to carry warning labels that the medications increase the risk of suicidal thoughts and behaviors in children and adolescents.
93 Suspected Cases Worldwide
Sanz and colleagues studied adverse drug reaction records maintained by the World Health Organization. The database includes more than 3 million records on all kinds of drugs, reported by 72 countries.
By November 2003, WHO records showed 93 suspected cases of SSRI-induced withdrawal symptoms in newborns. Of those cases, 64 were associated with Paxil, 14 with Prozac, nine with Zoloft, and seven with Celexa.
Neonatal withdrawal syndrome associated with SSRIs is characterized by convulsions, irritability, abnormal crying, and tremor, say the researchers.
"SSRIs, especially [Paxil], should be cautiously managed in the treatment of pregnant women with a psychiatric disorder," write the researchers.
Most Reports Centered on Paxil
Nearly two-thirds of the reports were related to Paxil. The researchers say Paxil "should not be used in pregnancy, or if used, should be given at the lowest effective dose."
The researchers don't conclude that Paxil withdrawal is more of a problem than that of other drugs. They don't know why Paxil prompted more reports. "It certainly gives a strong suggestion that symptoms of withdrawal might be a greater problem for [Paxil] than for other drugs," they say.
Left untreated, major depression during pregnancy can lead to poor nutrition, insomnia, and an increased risk of smoking, drinking alcohol, using drugs, or other behaviors that risk health. Also, such women may be less likely to seek prenatal care. And there's the potentially devastating effect on the newborn: Untreated major depression during pregnancy can raise the risk of premature labor and low-birth-weight babies.
Depression during pregnancy should not be ignored. Every situation is different. Women should talk to their doctors to determine the risks of depression during pregnancy against any potential risks of treatment.
Of the Paxil cases, only 13 reports cited a dose (10 to 50 mg per day). Eight cases reported how long the drug had been taken (four moths to five years, stopping at delivery).
The first possible SSRI baby withdrawal case was entered into the WHO's database in 1995. That case concerned fluoxetine (sold as the brands Prozac and Sarafem). The researchers also say that "an association between [Paxil] and neonatal convulsions was identified in December 2001" by mining WHO data.
"It would be unwise to assume the other SSRIs are immune to the problem," say Vladislav Ruchkin and Andrés Martin of Yale University's medical school, commenting in The Lancet.
"It remains to be seen whether Sanz and colleagues' report ultimately reflects a minor problem for a particular antidepressant, or further evidence of a larger set of serious problems for SSRI use in young people," they write.
Previous Paxil Study
In 2002, a small study on Paxil and babies' withdrawal symptoms was reported at the annual meeting of the Pediatric Academic Societies.
University of Toronto researcher Gideon Koren, MD, studied 55 women who took Paxil while pregnant, 27 who stopped taking Paxil after their second trimester, and 27 who took other drugs not considered harmful during pregnancy.
Twelve of the babies exposed to Paxil through the third trimester had complications that lasted one to two weeks and required hospitalization. Nine of those babies had respiratory problems, two had low blood sugar, and one had jaundice.
In all of those cases, the babies got better. There were no long-term negative effects from Paxil, and Koren told WebMD that he didn't think there should be any real concern about taking Paxil through pregnancy. However, he did suggest careful monitoring of the baby of any woman on an SSRI.
Patients should consult their doctors with any questions about SSRIs and pregnancy.