Daiichi-Sankyo, Bayer, Otsuka and Others Called Out for UK Advertisement Breaches

Regulatory NewsRegulatory News | 12 August 2019 |  By 

The UK’s Prescription Medicines Code of Practice Authority (PMCPA) this month and next month will publish ads in the British Medical Journal, the Pharmaceutical Journal and the Nursing Standard to highlight misleading advertisements and promotional materials made by companies Daiichi-Sankyo, GW Pharmaceuticals, Bayer, Otsuka and Proveca.

In the case of Daiichi-Sankyo, the company issued a corrective statement for distributing two information guides on Lixiana (edoxaban) for failing to include a specific warning.

Bayer was called out for a misleading claim about Xarelto (rivaroxaban) which potentially put the safety of patients with severe renal impairment at risk, and GW, meanwhile, was criticized for promoting its seizure treatment Epidiolex (cannabidiol) before it won marketing authorization.

Otsuka was also reprimanded for failing to communicate changes to the summaries of product characteristics (SPCs) from 2017 for Jinarc (tolvaptan), Samsca (tolvaptan) and Abilify (aripiprazole), and for failing to update prescribing information and relevant materials and to withdraw materials in a timely manner.

PMCPA said its Appeal Board “was very concerned that an overall failure of governance processes at Otsuka Europe and Otsuka UK to implement and update SPC changes and update materials in a timely manner had potential patient safety implications. Otsuka Europe and Otsuka UK were publicly reprimanded and were required to be audited.”

In addition, Proveca sent a letter to pharmacists supplying unlicensed and off-label glycopyrronium that compete with the company’s product, known as Sialanar (glycopyrronium bromide). PMCPA said the letter “could be seen as threatening in tone.”



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