Comment from Zhang Joanne
AnonymousSupportIndividual
Summary: Lauren H. Schwartz, writing as a parent, supports the citizen petition and requests specific safety measures including mandatory boxed warnings, public hearings, and enhanced adverse event reporting.
I, as a parent, support the petition and the following are what I am asking for:
1. A mandatory boxed warning under 21 C.F.R. § 201.80(e) naming stroke, cancer, sterility, venous thromboembolism risk and cognitive decline
2. A “Part 15” public hearing to get transparent scientific debate on the record
3. A comprehensive safety review and REMS evaluation
4. Mandatory enhanced adverse event reporting
5. Development of communications for medical providers regarding safeguards