OFFICIAL DOCUMENTS
FDA - 2011. Eli Lilly.
In April 2011, Eli Lilly sent a letter to the FDA acknowledging that there had been the “occasional persistence of sexual dysfunction following discontinuation of fluoxetine treatment” in trials, urging them to update their adverse reactions section of the Fluoxetine drug leaflet.
MHRA - 2009 - Assessment Report
In this September 2009 report, Eli Lilly shared clinical findings (in human patients) with the UK's medication regulator (MHRA). The MHRA wanted Eli Lilly to determine if there was any data that suggested Prozac (fluoxetine) affected sexual development in juvenile patients. Eli Lilly ultimately convinced the regulator that a clinical study would be too complex to conduct and the results would be too difficult to interpret.
EMA - 2006. Prozac.
In 2006 the European Medicines Agency (EMA) signed a Post-Marketing Agreement with Eli Lilly to ensure that the SSRI Prozac (fluoxetine) is safe for children and adolescents. Prozac was the only antidepressant given European marketing authorization to treat moderate to severe depression for children aged 8 and up. The EMA was in part concerned because of evidence from animal studies that show SSRIs cause testicular toxicity. The EMA requested further studies from Eli Lilly, because they were concerned about whether Prozac interfered with sexual maturation and fertility.
Sweden - 2009. LV - Prozac
In September 2009, Sweden's medication regulator, the Medical Products Agency (Läkemedelsverket, LV), commented on the findings of the UK's MHRA and France's ANSM in this email. Although Sweden wasn't one of the 2 reference countries chosen to handle this Post-Marketing Agreement for Prozac, their regulator still expressed concern that more research was needed to prove that the medication was safe for juveniles.
Prozac FUM - Pre Clinical 2008.
In July 2008, Eli Lilly submitted this report to the UK's MHRA. The purpose of this report is to assess the findings of juvenile toxicity studies conducted to investigate the effect of Prozac (fluoxetine) on neurohormonal sexual maturation and testicular pathogenesis in rodents.