Yesterday, the Toronto Star reported that an unapproved anti-nausea drug used for morning sickness is linked to birth defects. The drug—ondansetron—is being prescribed by doctors for Hyperemesis gravidarum (the kind of extreme morning sickness that Kate Middleton had). Ondansetron is approved by Health Canada for chemotherapy patients; yet, it has not been given the go-ahead to treat pregnant women. However, some doctors have been prescribing the drug “off label” to help expectant moms handle cases of extreme vomiting.
The Star went through reports from the US-based Food and Drug Administration (FDA) and found that at least 20 pregnant Canadian women treated with ondansetron experienced side effects, including two infant deaths and multiple cases of babies born with heart and kidney defects.
According to the Star:
- Four of the Canadian babies from the FDA documents reviewed by the Star were born weighing as little as four-and-a-half pounds. In six cases, a suspected side-effect of ondansetron was listed as “fetal growth restriction.”
- The Star looked at Canadian side-effect reports filed with the FDA database between 2010 and 2013. Each report is based on the opinion of a doctor, pharmacist or patient.
- To further complicate the issue, a study published in the prestigious New England Journal of Medicine said that ondansetron was safe for fetuses, although another study contradicted the findings.
This is scary news for women who have already taken the drug, or who are so sick that doctors prescribe it as a last resort. A mother quoted in the Star said that it was the only thing that stopped her constant vomiting. Luckily, her daughter did not have any side effects, but she says that she would take it again because it was the only thing that got her through her pregnancy.
Read more: The facts of morning sickness>
Ondansetron is not related to Diclectin (doxylamine-pyridoxine), which is approved by Health Canada for nausea during pregnancy and does not have any known side effects.
Did you take a drug to ease your vomiting and nausea while pregnant?