Bristol-Myers Squibb and Pfizer v Daiichi-Sankyo

Promotion of Lixiana

On 14 December 2018 the following corrective statement was issued by Daiichi-Sankyo

Between July 2016 and 20 August 2018, a Lixiana (edoxaban) Initiation Information Guide (ref EDX/16/0171) and/or a Lixiana Practical Guide (ref EDX/15/0091(4)) might have been provided to you by Daiichi-Sankyo UK Limited. 
Section 4.4 of the Lixiana SPC, Special warnings and precautions for use, states under the sub heading ‘Renal function in [nonvalvular atrial fibrillation] NVAF’:

‘A trend towards decreasing efficacy with increasing creatinine clearance was observed for edoxaban compared to well-managed warfarin (see section 5.1). Therefore, edoxaban should only be used in patients with NVAF and high creatinine clearance after a careful evaluation of the individual thromboembolic and bleeding risk.

Assessment of renal function: CrCL should be monitored at the beginning of the treatment in all patients and afterwards when clinically indicated (see section 4.2).’

Daiichi-Sankyo apologises for the fact that the items at issue failed to include this warning other than in the prescribing information. Daiichi-Sankyo takes its responsibilities under the ABPI Code of Practice for the Pharmaceutical Industry and patient safety seriously and is disappointed at these failings. As an organisation we will take all possible steps to ensure that this is not repeated.

Following a complaint under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Appeal Board ruled that the omission rendered the materials misleading and therefore the materials did not encourage the rational use of the medicine. The Appeal Board also ruled that Daiichi-Sankyo had failed to maintain high standards and had brought discredit upon and reduced confidence in the pharmaceutical industry. As a result of the above Daiichi-Sankyo has been required to issue this corrective statement and to refer to the published report for the case which contains full details. In addition Daiichi-Sankyo has been required to recover the material at issue. If you still have the material at issue please return it in the attached prepaid envelope as soon as possible.

On 14 December Daiichi-Sankyo sent the following Corrective Statement to recipients of the material at issue and relevant UK prescribers.