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A healthcare professional complained to the MHRA about an advertisement for BuTrans Transdermal Patches produced by Napp Pharmaceutical Limited for healthcare professionals, which was published in BMJ of 22 March 2008. The complainant was concerned th at the advertisement was misleading as it was not clear that the product was a second line treatment for severe osteoarthritis pain.
The MHRA did not uphold the complaint.
It is well established in the target audience that strong opioids are not first line options in osteoarthritis (OA), even in severe pain. This has been re-inforced by the recent NICE guidance in OA. This guidance does however note that "if paracetamol or topical NSAIDs are insufficient for pain relief for people with osteoarthritis, then the addition of opioid analgesics should be considered. Risks and benefits should be considered, particularly in elderly people."
The indication is given in full in the Prescribing Information which also details the contra-indications and key warnings etc which put the claims into context. The font size meets the standard set in guidance.
There is also text underneath the main strapline to note that it is a strong opioid. This is a factual statement, but also gives the impression of a warning. This text is of an appropriate size to be clearly legible to readers.
Date case raised: 25 March 2008
Date action agreed: 1 April 2008
Date of publication: 22 April 2008
