AUTH/3319/3/20 - Complainant v AstraZeneca

Concerns about promotion of Symbicort

  • Received
    10 March 2020
  • Case number
    AUTH/3319/3/20
  • Applicable Code year
    2019
  • Completed
    01 July 2020
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned UK health professional, complained about promotional material for Symbicort (budesonide/formoterol) created by AstraZeneca UK Ltd and hosted on the Guidelines in Practice website. Symbicort was variously indicated for use in the treatment of asthma and/or chronic obstructive pulmonary disease (COPD) according to the strength and formulation used.

The complainant was concerned that the prescribing information which was available on a downloadable formulary decision guide was out-of-date as there had been two updates since it was created. The complainant noted that Section 4.4, Special warnings and precautions for use, of the summary of product characteristics (SPC) had had the following text added ‘Complete withdrawal of inhaled corticosteroids should not be considered unless it is temporarily required to confirm diagnosis of asthma’.

The complainant alleged that the omission of that statement could be a patient safety issue, especially as the material at issue was to help guide formulary decisions and treatment algorithms.

The detailed response from AstraZeneca is given below.

The Panel noted that the formulary decision guide in question clearly related to the use of Symbicort in the treatment of COPD. The complainant had drawn attention to a statement included in Section 4.4, Special warnings and precautions for use, of the Symbicort SPC ie ‘Complete withdrawal of inhaled corticosteroids should not be considered unless it is temporarily required to confirm diagnosis of asthma’. AstraZeneca submitted that this warning was specific to the treatment of asthma and thus did not need to be included in COPD prescribing information.

On the basis of the information before it, the Panel considered that there was no evidence that the warning in question should have been included in the COPD prescribing information and so in that regard it ruled no breach of the Code.
The complainant gaveno reasons for his/her concern regarding patient safety and had not explained how and why omission of the warning would, as implied, hinder rational formulary decisions or treatment algorithms. The Panel noted that the prescribing information in the formulary decision guide for Symbicort in COPD included the statement, under ‘Warnings and Precautions’, ‘Treatment should not be stopped abruptly without supervision by a physician’. Readers were also advised to consult the SPC before prescribing which the Panel considered they would do before making any formulary decisions or treatment algorithms.
The Panel considered that the complainant had not established that AstraZeneca had failed to maintain high standards and no breach of the Code was ruled. It also ruled no breach of Clause 2.