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Taking the popular antidepressant Paxil while pregnant can harm newborn babies, new Canadian research suggests.
Doctors at Toronto's Hospital for Sick Children suspect babies can suffer from "discontinuation syndrome" -- withdrawal symptoms -- if their mothers used the drug during the last three months of pregnancy.
In their study, 12 babies born to 55 women who took Paxil during the third trimester suffered from complications in their first weeks of life, including respiratory distress, hypoglycemia and jaundice. All of the babies recovered within two weeks.
On the other hand, only three babies of 54 born to a control group endured similar complications. Their mothers quit taking Paxil by the second trimester or took another drug altogether.
"This highly suggests that paroxetine [Paxil] exposure near term may compromise fetal and natal health," said Dr. Adriana Costei, who presented the research at the Pediatric Academic Societies annual meeting in Baltimore yesterday.
"The fact that the adverse events were brief, without other underlying pathology, further supports drug exposure as the mechanism for the adverse effects."
The solution may seem straightforward -- pregnant women should not take the drug immediately before their due dates -- but the reality is much more complicated, said Dr. Gideon Koren, the lead researcher and a professor of pediatrics, pharmacology and medicine at the University of Toronto.
"The context is very serious," he said. "These are not conditions in which you can easily tell women to stop taking the drug."
Women often take Paxil because they suffer from clinical depression. Switching to another drug does not always ease their symptoms and quitting the treatment, even for just a few months, can have dire consequences, Dr. Koren said.
He referred to the case of Suzanne Killinger Johnson, the Toronto psychologist who leaped in front of a Toronto subway train with her baby in her arms two years ago. She had apparently stopped taking antidepressants because she feared the medication could poison her son through her breast milk.
Paxil belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs) that also includes Zoloft and Prozac. They all work by adjusting the amount of serotonin in a person's brain, but each drug has a different "half-life," meaning it stays in a person's body for a different length of time.
Paxil leaves the body more quickly than others and can "jolt" the nervous system if patients miss doses or suddenly stop their treatment. Past studies have shown people taking Paxil suffer from withdrawal reactions more often than people taking other SSRIs, Dr. Koren said.
The babies' adverse complications are probably their version of withdrawal, because the drug readily enters the placenta when a patient is pregnant, he added.
The researchers say their study is the first to link higher rates of perinatal complications with Paxil.
Three Canadian class actions have been filed against GlaxoSmithKline in the past week alleging thousands of Paxil users suffered withdrawal reactions when they attempted to reduce or discontinue their daily doses of the drug, and that the company failed to warn users of the drug's addictive nature. The allegations have not yet been proven in court.
A statement released yesterday by GlaxoSmithKline acknowledges discontinuation symptoms may occur in some Paxil patients, but stresses they are usually mild, short-lived and can be minimized by slowly reducing the dosage over time.
"Although animal studies have not shown any teratogenic or selective embryotoxic effects, the safety of Paxil in human pregnancy has not been established," the statement notes. "Paxil should not be used during pregnancy unless the potential benefit to the patient outweighs the possible risk to the fetus."
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