LOOK BEYOND APPROVAL

Safety findings

Reported safety narratives, with historical warnings and uncertain findings separated. Read the record and supporting citations before drawing conclusions.

The categories on this page are editorial groupings for navigation. Each medical narrative below is taken from the therapy record; neither the grouping nor the underlying claim is an independent clinical validation. A note may refer to a different indication, dose or formulation. “No withdrawal” is not treated as a withdrawal; a separate explicit adverse-effect description can still be shown.

Platelet-derived growth factor BB in gelatin hydrogel sheetsNo trauma translation

FDA boxed warning added 2008 (increased cancer mortality with >=3 tubes); boxed warning REMOVED by FDA Dec 2018 after post-market studies showed no increased risk

The supplied narrative explicitly says the warning was removed. Shown as historical, not as a current warning.

Sources (4)

ChEMBL (EMBL-EBI) CHEMBL1201556 (BECAPLERMIN), max_phase 4, first_approval 1997
US Pharmacist/Healio: 2008 FDA boxed warning (cancer mortality, >=3 tubes)
Smith+Nephew/FDA: Dec 2018 removal of Regranex boxed warning
ClinicalTrials.gov NCT00034788 (diabetic ulcer), NCT00812513 (burns)

PTH(1-34), teriparatideNo trauma translation

Previously carried a boxed warning for osteosarcoma (rodent data) with a 2-year lifetime limit; FDA removed the boxed warning and cumulative-use limit in 2020.

The supplied narrative explicitly says the warning was removed. Shown as historical, not as a current warning.

Sources (3)

ChEMBL (EMBL-EBI)
ClinicalTrials.gov (NIH/NLM)
FDA 2020 removal of teriparatide osteosarcoma boxed warning