GSK breached ABPI Code over Zejula AE management webpage that omitted discontinuation scenarios

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Key facts

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Case number	AUTH/3836/10/23
Company	GSK
Complainant	Anonymous, contactable complainant (health professional)
Medicine	Zejula (niraparib)
Material/channel	Promotional webpage on GSKPro (Zejula section), page titled “PRIMA AE management”
Main issue	AE management claims implied dose interruption/modification was sufficient and did not highlight that discontinuation may be required in certain circumstances per the SmPC
Applicable Code year	2021
Breach clauses	Clause 6.1; Clause 5.1
No breach clauses	Clause 11.2; Clause 2
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	10 October 2023
Case completed	13 September 2024
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous, contactable health professional complained about a GSK promotional webpage for Zejula (niraparib) on the GSKPro site, titled “PRIMA AE management”.
The webpage stated: “If your patients have any side effects with ZEJULA (niraparib), they may be managed via dose interruption and modification”.
It also stated: “Regularly monitoring your patient’s complete blood count and blood pressure can help identify when dose modification may be required”.
The complainant alleged the page was misleading because it did not mention that the SmPC requires discontinuation in certain circumstances (eg severe persistent haematologic toxicity/pancytopenia not resolving within 28 days, confirmed MDS/AML, hypertensive crisis or uncontrolled medically significant hypertension).
GSK acknowledged the webpage should have included clearer information about discontinuation scenarios and accepted breaches of Clauses 6.1 and 5.1, but denied breaches of Clauses 11.2 and 2.
The Panel considered the page’s layout, including the statement: “Please refer to the SmPC when making prescribing decisions. The information provided here is to supplement rather than replace advice in the SmPC”.
The Panel emphasised it was well established that each webpage should be capable of standing alone.

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Breach of Clause 6.1 (Making a misleading claim).
Breach of Clause 5.1 (Failing to maintain high standards).
No breach of Clause 11.2 (Promotion in accordance with marketing authorisation / not inconsistent with SmPC).
No breach of Clause 2 (Discredit to the industry).

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