Claims based on tolerability

In Case AUTH/3231/7/19 and AUTH/3255/7/19 (Complainant v Shield & Norgine), one of the Complainant's issues was that claims that the product was well tolerated were not supported by the SPC. The SPC listed 6 adverse events in the common category. The Complainant viewed that this meant that the product was not well tolerated.

The Respondent(s) noted that there is a difference between tolerability and adverse events. The listed common side effects were mild-moderate in severity. The EPAR described the safety profile as “reassuring”. Reported adverse events were similar to those described for other similar products, and their incidence was low. The EPAR included a statement that the product had ‘ acceptable safety profile although 18% of patients discontinued treatment...’.

The Panel did not consider that the complainant had shown on the balance of probabilities that there was evidence to show the medicine was not well tolerated. Taking all circumstances into consideration, the Panel did not consider that the number of common adverse events necessarily meant that the product was not well tolerated. The Panel did not consider that the claim was inconsistent with the SPC as alleged. The Panel ruled no breaches of the Code in this regard.

See the full case here:

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