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Japan tells Pfizer, Bayer, Daichi and others to expand drug warnings

By Gareth MacDonald+



The MHLW has ordered Pfizer, Bayer, Daichi Sankyo and firms selling generic warfarin and azithromycin in Japan to expand their products’ adverse event warnings.

The Ministry of Health, Labor and Welfare (MHLW) issued an order on August 3 telling warfarin manufacturers to change warning labels to include the risk of calciphylaxis – the accumulation of calcium in blood vessels.

The regulator cited 11 cases of calciphylaxis - which included one death - seen in Japan in the past few years as the basis for the order, explaining that a causal link to the anticoagulant cannot be ruled out. 

Similarly, manufacturers of generic drugs containing azithromycin – the active pharmaceutical ingredient (API) in Pfizer’s antibiotic Zithromac – were told to add details of a potential risk of acute exanthematous pustulosis, a rare skin condition, to their products’ labels.

Again the MHLW cited cases of the condition in Japan as the prompt for the order.

Bayer and Daiichi Sankyo 

In addition, Bayer Yakuhin, a unit of German drug manufacturer Bayer, has been told to revise the labelling for its pulmonary arterial hypertension (PAH) treatment Adempas (riociguat).

The MHLW said data from a clinical trial called RISE-IPP suggested deaths among PAH patients suffering from lung lesions was higher in the group that received the Bayer product than the placebo group.

The agency also told Japan based drug firm Daiichi Sankyo to add the risk of bronchospasm and dyspnea for to its flu treatment Inavir (laninamivir).

The MHLW said a link between three of eight cases observed in Japan in the past three years and the neuraminidase inhibitor cannot be ruled out.

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