Teva and Daiichi Sankyo found in breach of the UK ABPI Code


Both Teva and Daichi Sankyo have been found to be in breach of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice by the Prescription Medicines Code of Practice Authority (PMCPA).

Teva was ruled in breach of several clauses of the 2019 Code for failing to include the black triangle for Ajovy in an article which, in the Panel’s view, Teva was responsible for and was promotional.

This was compounded by a failure to include an adverse event reporting statement, for failing to include prescribing information for Ajovy and Copaxone, and for failing to certify the article.

The company was also penalised for describing Copaxone as ‘new’ when it had been available for more than 12 months in the UK, and including a statement in the article which implied that Copaxone was licensed for all types of multiple sclerosis which was not so.

Daiichi Sankyo was found to be in breach of the Code for using a claim which misleadingly implied that Nilemdo (bempedoic acid) could be used therapeutically in combination with any oral lipid lowering treatment without making the contraindication with simvastatin >40mg daily immediately apparent.

In a separate case, Daiichi Sankyo was criticised for referring to the therapeutic use of Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) in combination with a statin/other lipid lowering therapies, without highlighting that they were contraindicated with simvastatin>40mg.

Because simvastatin is a commonly prescribed statin, the panel concluded that there was a risk that some patients on simvastatin >40mg daily might be inappropriately treated with Nilemdo or Nustendi.

The company was also found in breach for the repeated failure to comply with the Code on this matter which might prejudice patient safety.

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