AUTH/3149/1/19 - Anonymous Complainant v Endo Ventures

Promotion of Fluoxetine

  • Received
    09 January 2019
  • Case number
  • Applicable Code year
  • Completed
    30 April 2019
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2019 Review

Case Summary

A complainant who described him/herself as a concerned UK health professional, complained about an advertisement for fluoxetine issued by Endo Ventures.  Fluoxetine’s indications included the treatment of major depressive episodes in adults.  The advertisement included a claim for fluoxetine ‘for treatment of depressive illness’. 

The complainant alleged that ‘depressive illness’ as referred to in the advertisement was broader than the licensed indications.

The detailed response from Endo Ventures is given below.

The Panel noted that fluoxetine was indicated for adults for major depressive episodes, obsessive compulsive disorder or bulimia nervosa and for children and adolescents aged 8 years and above for moderate to severe major depressive episodes.  The Panel noted that these indications were given in the prescribing information in the advertisement as were details about the age range for use of the medicine.  The first mention of an indication was in the advertisement where the claim ‘for treatment of depressive illness’ appeared below the product name.  The Panel considered that the claim was not an accurate reflection of any of the fluoxetine indications and was therefore inconsistent with the SPC.  The Panel ruled a breach of the Code as acknowledged by Endo Ventures. 

The Panel considered that high standards had not been maintained and ruled a further breach.