Grant: Rapid Funding for DSEN Targeted Research - Prospective Studies

This research project investigates the safety of ondansetron, a drug that is used to treat severe nausea and vomiting. The work is in response to a safety question raised by Health Canada and the Drug Safety and Effectiveness Network regarding the effect this drug may have on the heart. More specifically, this study focuses on children and pregnant women, two groups of patients who may be particularly susceptible to developing adverse reactions from this medication. We will ask children from British Columbia, Ontario and Quebec and pregnant women from British Columbia and Ontario, who receive ondansetron, to participate in this study. In participating patients, we will monitor their heart while they receive the drug and collect information about previous conditions and other medications the patients receive to see if use of ondansetron in certain circumstances increases the risk of heart problems. We believe that a person's genetic make up may also help us understand which patients are most likely to suffer an adverse effect from ondansetron. Thus, we will collect a DNA sample from all study participants and conduct genetic analyses to determine if certain genetic factors put patients at increased risk of heart problems from ondansetron. Results of this study will help doctors decide how to best use ondansetron so it is safe for children and pregnant women who require treatment of severe nausea and vomiting.