Study Questions SSRI use in Pregnancy
Reported February 4, 2005
(Ivanhoe Newswire) — Women who use antidepressants during pregnancy may run the risk their newborns will be born with neonatal withdrawal syndrome, a condition characterized by convulsions, irritability, abnormal crying, and tremors.
According to investigators publishing in this week’s issue of The Lancet, 93 such cases have been reported worldwide since antidepressant drugs known as serotonin reuptake inhibitors, or SSRIs, were introduced in the late 1980s. The researchers found the cases by searching the World Health Organization’s database on adverse drug reactions, which includes more than 3 million health records from 72 countries.
Among the 93 cases identified by the report, 64 were in babies whose mothers took paroxetine (Paxil). Fourteen cases involved fluoxetine (Prozac or Sarafem), nine were related to sertraline (Zoloft), and seven involved citalopram (Celexa).
Since two-thirds of the cases involved paroxetine, the researchers call for doctors to use particular caution when considering that drug for their pregnant patients, writing, “Paroxetine should not be used in pregnancy, or if used, it should be given at the lowest effective dose.”
Doctors prescribing other SSRIs, including fluoxetine and sertraline, should carefully monitor patients and remain vigilant about identifying any cases of neonatal withdrawal syndrome and reporting those cases to drug vigilance systems.
In an accompanying commentary, Yale University School of Medicine researchers in New Haven, Conn., warn more study is needed to determine whether the problems seen in this study are limited to a particular antidepressant or whether all the drugs in the SSRI class might cause similar problems. In the meantime, they too call for doctors to more carefully assess the use of these drugs, noting this study and others continue to question the safety of these medications in some people. They write, “The threshold for prescribing antidepressants could have unwittingly been set too low.”
SOURCE: The Lancet, 2005;365:482-487, 452-452