Safety information announced by MHLW: Alert for the risk of severe hypocalcemia in patients who take RANMARK® (denosumab)

The Yellow Letter / Blue Letter

To prevent health hazards associated with the use of drugs and medical devices, it is important that post-marketing reports of adverse reactions and defects be collected and reviewed in order to promptly provide feedback about necessary information to medical institutions.

According to Article 77-4 of the Pharmaceutical Affairs Law (Law No. 145, 1960), when MAHs of drugs or medical devices learn that the use of drugs or medical devices that they have marketed might cause onset or spread of hazards to public health or hygiene, necessary measures shall be taken, including recall, suspension of sales, and information provision to prevent such hazards.

Based on the above provision, various types of safety information have been provided. Particularly important safety information which requires immediate communication is provided through the Dear Healthcare Professional Letters of Emergent Safety Communications (Yellow Letter) or Dear Healthcare Professional Letters of Rapid Safety Communications (Blue Letter). The Yellow Letter contains emergent and important safety information about drugs and medical devices. The Blue Letter contains information that does not require emergent communications as Yellow Letter but should be promptly provided to alert healthcare professionals.

Copies of letters sent to healthcare professionals

Date sent Dear Healthcare Professional Letters Relevant case reports
September 11, 2012
PDF RANMARK (denosumab) – Risk of severe hypocalcaemia, including fatal cases (PDF) PDF Severe hypocalcaemia fatal cases where the causal relationship to RANMARK (denosumab) cannot be ruled out (PDF)

Pharmaceuticals and Medical Devices Agency


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