NOACs such as Dabigatran, Rivaroxaban, Apixaban and others have rapidly taken over from the use of Warfarin when anticoagulation is recommended. The exception is mechanical valve replacement for which Warfarin is recommended but this may change.
NOACs have been showed to be as effective as Warfarin, and to have a lesser risk of bleeding generally. While the gastrointestinal risk of bleeding is a little higher than for Warfarin, there is lower risk of intracranial haemorrhage. The NOACs have however a number of characteristics which are of aeromedical concern, for these reasons not all states accept the use of NOACs by pilots. These characteristics are:
- Compliance cannot be reliably ascertained;
- Their biological effect in a particular individual is not well known;
- Overdose may occur, for instance if there is decreased renal function or small body mass for the dose prescribed;
- Long haul pilots flying through multiple time zones may have difficulties taking their medication at the appropriate time. This is not unique to this medication;
- While the effects of Dabigatran can be reversed rapidly (i.e. with Praxbind®), the availability of the antidote and its cost are a barrier to access.
Information to be provided
- Medication generic name and dose;
- Renal function;
- Confirmation of absence of any complication relating to the use of NOACs;
- All information relating to the condition being treated.
An applicant taking NOACs should be considered as having a condition that is of aeromedical significance, unless:
- The condition being treated may be considered as not being of aeromedical significance while being treated;
- The renal function is not significantly impaired: i.e. eGFR ≥60 ml/min/1.73m2;
- The dose is appropriate for the body size;
- There have been no episodes of spontaneous or major bleeding;
- A restriction 'not valid for single pilot air operations carrying passengers' is imposed in the case of a Class 1 medical certificate and the exercise of the privileges conferred by the certificate is not permitted if any the medication has been omitted in the past 48 hours.