AUTH/2645/10/13 & AUTH/2647/10/13: Patient v Amgen and GlaxoSmithKline (Prolia) – No breach | PMCPA Case

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Key facts

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Case numbers	AUTH/2645/10/13 and AUTH/2647/10/13
Parties	Complainant: Patient; Companies: Amgen UK Limited and GlaxoSmithKline UK Limited
Medicine	Prolia (denosumab)
Issue type	Patient information; alleged missing/withheld side-effect information; foreign-language leaflet; “yellow marker/black triangle” concerns; correspondence with company
Applicable Code year	2012
Complaint received	20 October 2013
Case completed	19 February 2014
Result	No breach
Clauses considered	2, 4.10, 4.11, 7.2, 7.6, 7.9, 9.1 and 22.2
Appeal	Complainant appeal; unsuccessful (Panel rulings upheld)
Notable materials	Patient booklet “Understanding Osteoporosis” (Prolong Patient Support programme), ref DMB-GBR-AMG-037-2012/UK/DNB 0002g/12/32043984

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

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A patient prescribed Prolia (denosumab) complained about information supplied by Amgen UK; GlaxoSmithKline (GSK) was involved as co-promoter.
The patient received a Prolia injection at a hospital (August 2012) and said she was told side effects were only those in a leaflet from a national patient support group, which she alleged was inaccurate.
After administration, she was given a German package leaflet and alleged this prevented her from identifying side effects and implied the medicine was not licensed for UK use.
She reported mouth/tongue ulcers and cracks at the side of her mouth within 3–6 weeks and alleged these were not disclosed pre-treatment; she also alleged Prolia had a “yellow card marker” and that she was not told it was “still on trial”.
She complained about Amgen’s subsequent correspondence, alleging it denied knowledge of mouth ulceration and only referred to osteonecrosis of the jaw (ONJ), despite patient materials listing “persistent pain and/or non-healing sores of the mouth or jaw” as a rare side effect.
The PMCPA considered the complaint under the 2012 Code and within the scope of the Code (noting some issues raised were outside scope, including non-promotional package leaflets).

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No breach of the Code was ruled for Amgen and for GSK.
The Panel found that the foreign-language package leaflet issue and the content of non-promotional package leaflets were outside the scope of the Code and not Amgen’s responsibility under the Code.
No breach was found regarding adverse event reporting statements/black triangle display because no Prolia promotional material was provided by the complainant (burden of proof not met).
The Panel found Amgen’s correspondence was not misleading and was a fair reflection of the SPC regarding adverse events.
The patient support booklet (“Understanding Osteoporosis”, Prolong Patient Support programme) sponsored by Amgen and GSK was considered a fair reflection of the UK SPC.
The complainant appealed; the Appeal Board upheld the Panel’s rulings (appeal unsuccessful).

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