Health Canada, the agency responsible for regulating prescription medication in Canada, announced last year that it will provide the public with more drug side effect information, in particular complications that occur when a medication is used for an “off-label,” or unapproved uses. The July 3rd announcement followed the publication of a Toronto Star investigation that detailed reports linking off-label use of Zofran with birth defects.
A month before announcing the promised change, the Star reported that Health Canada removed mention of such incidents before they were published in the agency’s online database. Following that report, a spokesperson for the agency told that Star that the reporting system is being updated, and will disclose the once-omitted information once that is complete.
In July 2014, the Toronto Star published an investigation detailing at least 20 Canadian women who had given birth to children with serious birth defects, including heart malformations and oral clefts, after taking Zofran or a generic equivalent during their pregnancies. Zofran is currently not approved to treat pregnancy-related nausea and vomiting, and to access side effect information related to its off-label use, the Star had to search the database maintained by the U.S. Food & Drug Administration.
“Health Canada, which has similar reports in its internal database, said it has not done any reviews of these cases and there are currently ‘no emerging safety issues requiring further assessment’ of the drug’s use for morning sickness,” the Star reported.
Since the Star published its report, a number of Zofran lawsuits have been filed in the U.S. on behalf of children who were allegedly born with serious congenital malformations due to their mothers’ use of the drug in the first trimester of pregnancy. Among other things, these lawsuits accuse GlaxoSmithKline of concealing the drug’s alleged link with birth defects, and of illegally promoting its use as a treatment for pregnancy-related nausea and vomiting.
Because Zofran and its generic counterparts are prescribed to about 1 million pregnant women in the U.S. every year, it’s expected that the litigation involving the drug will grow. If you think this medication harmed your baby, please contact a Zofran lawyer calling (888) 881-3077 to learn more about joining this growing litigation.