None of the 70,000 Adverse Events of Puberty Blocking Drugs Were a “Safety Priority” for Biden’s FDA

 This summary examines the concerns raised regarding the FDA's handling of adverse events related to puberty-blocking drugs and their safety monitoring.

• The FDA established the Safety First Steering Committee (SFSC) in the early 2000s for drug safety, which is now thought to have been transitioned to the Drug Risk Management Board (DRMB).

• The DRMB lacks transparency, and its reports do not mention the off-label use of hormone modulators in children for gender transition, missing over 70,000 adverse event reports.

• Under the leadership of Dr. Patrizia Cavazzoni, previously affiliated with Big Pharma, significant adverse outcomes from puberty blockers, such as deaths and disabilities, were not prioritized.

• The FDA's annual drug safety reports have consistently failed to acknowledge these adverse events associated with puberty blockers.

• These medications, initially designed for serious health conditions, are now prescribed to healthy children, leading to serious health risks, including heightened chances of stroke and cardiac issues.

• The FDA has issued warnings about the potential life-threatening effects of puberty blockers but did not actively inform the public, contrasting sharply with the attention given to drugs like hydroxychloroquine.

• Calls for increased FDA transparency and a focus on drug safety were highlighted, particularly with the new administration under President Trump aimed at reforming safety protocols.

The FDA's neglect in addressing the serious safety issues surrounding puberty-blocking drugs raises significant concerns about the health risks posed to children and the efficacy of the agency's monitoring processes. Through increased focus on drug safety and transparency, it is hoped that more robust protections will be delivered to the public.

https://brownstone.org/articles/none-of-the-70000-adverse-events-of-puberty-blocking-drugs-were-a-safety-priority-for-bidens-fda/