AUTH/3312/2/20 - Anonymous v Johnson & Johnson

Nicorette prescribing information

  • Received
    19 February 2020
  • Case number
  • Applicable Code year
  • Completed
    29 May 2020
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous complainant, who described him/herself as a concerned UK health professional, complained that the prescribing information in a journal advertisement (ref UK/NI/19-14927a) for Nicorette (nicotine), placed by McNeil Products Ltd, was out of date which could lead to adverse effects on patient safety. The prescribing information in the advertisement was dated June 2016; the advertisement was approved in November 2019. The complainant noted that the Nicorette summary of product characteristics (SPC) had been updated to include significant changes to Section 4.4 (Special warnings and precautions for use).

Nicorette was a brand of nicotine replacement therapy (NRT) indicated for use in adults and children over 12 years of age.

The detailed response from Johnson & Johnson, which owned McNeil Products Ltd, is given below.

The Panel noted that the changes implemented in Section 4.4 of the SPC in December 2019 were minor.

In the Panel’s view, the complainant had not established that the Section 4.4 SPC changes were such that consequential changes needed to be made to the prescribing information which had been approved in June 2016 and appeared in the advertisement at issue. No breach of the Code was ruled. The Panel noted Johnson & Johnson’s submission that when notification of the update was received, an assessment was made and no change was deemed necessary. There was no evidence that high standards had not been maintained and the Panel ruled no breaches of the Code including of Clause 2.