James_P_Reichmann_Citizen_Petition_Redacted (1)
The FDA has been facing a citizen petition attempting to change the indications of Zofran for pregnant women and greater warn about its relation to birth defects. We certainly hope the FDA reevaluates their position in light of the mounting evidence demonstrating statistically significant evidence of certain birth defects. The Petition filed in January 2012 cited early evidence linking ingestion risks during pregnancy. Since the study, there has been even more case studies and database analysis that demonstrate a causal relationship between Zofran and birth defects.