Contraindications for dabigatran extended to all newer anticoagulants
The Medicines and Healthcare products Regulatory Agency has advised that contraindications for dabigatran (Pradaxa) also now apply to the other newer oral anticoagulants apixaban (Eliquis) and rivaroxaban (Xarelto).
The agency said last August (2012) that, because of the risk of haemorrhage, dabigatran is contraindicated in a range of clinical conditions where the patient is at significant risk of major bleeding, as well as in combination with other anticoagulants. These contraindications have now been applied across all three newer oral anticoagulants, for all indications and doses, because similar risks are associated with apixaban and rivaroxaban, according to the October Drug Safety Update.
Black triangle will appear in PILs
The latest DSU also highlights that patient information leaflets will now include details about how to report suspected side effects via the yellow card scheme. Patients will also start to see the black triangle symbol in the PIL for relevant medicines.
The agency says it is encouraging healthcare professionals to point out to medicines users that they can report any suspected side effects directly to the MHRA, adding: “Do not worry about duplicate reports if a yellow card is submitted by both a professional and a patient (or carer) for the same suspected adverse reactions. We are able to detect duplicate reports and use the combined information provided when assessing each case.”
Earlier this year, the MHRA said that although yellow card reporting by pharmacists had risen from 1,752 in 2011 to 2,417 in 2012, reporting by members of the public had fallen to less than half the level of six years ago (3,584 in 2006 to 1,789 in 2012).
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11128652
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