Zofran Linked To Birth Defects, Adverse Fetal Outcomes In Hundreds Of Adverse ... - Legal Examiner
We asked for every adverse event report submitted in relation to GlaxoSmithKline’s Zofran, along with generic equivalents using the same active ingredient, ondansetron. Eventually, the FDA responded with two massive files of data, spanning from January of 1991 to April of 2015. In total, we received over 3,800 pages of reports comprising almost 8,700 individual adverse events. Then we sifted through the data, searching for any adverse event reports in which maternal or fetal exposure to Zofran had been listed as a suspected cause of birth defects , congenital abnormalities or other adverse fetal outcomes. On our website, you’ll find an infographic presenting the highlights of our analysis in visual form and a thorough breakdown of every birth defect and abnormality mentioned in the adverse event reports we received from the FDA. Zofran Suspected Cause Of Over 400 Birth Defects & Adverse Fetal Events, Monheit Law’s FOIA Request Reveals Between January 1, 1991 and April 30, 2015, Monheit Law identified 475 reports of birth defects and adverse fetal outcomes in which Zofran... In many instances, the FDA received multiple adverse fetal event reports naming Zofran as a suspected cause in a single day. While health care professionals are allowed to submit adverse event reports directly to the FDA, the vast majority of AERs we received had been submitted by. Source: montco.legalexaminer.com
