Prozac’s dark legacy: regulators ignored early warnings of sexual harm

Internal documents show Eli Lilly and regulators buried evidence that Prozac could permanently alter sexual development.

When Prozac was first approved for children in Europe nearly 20 years ago, regulators already knew the drug could interfere with sexual development.

Internal documents reveal that Eli Lilly, the manufacturer, and European authorities were aware of clear animal data showing delayed puberty, testicular damage, and disrupted hormones — yet they pushed ahead anyway.

The warnings were buried in annexes and footnotes, dismissed as “monitorable events” or “clinically irrelevant.” Studies that regulators demanded from Eli Lilly to clarify the risks were quietly shelved.

And now, two decades later, a new generation of patients is paying the price.