Published: 30 May 2016
Revised: 7 February 2017

Safety Information

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Rivaroxaban, dabigatran and apixaban and possible risk of hair loss (alopecia) added to the medicines monitoring scheme

30 May 2016

Monitoring finishes 31 December 2016

Medsafe is highlighting a possible risk of hair loss with the use of novel oral anticoagulants (NOACs). The NOACs available in New Zealand are rivaroxaban, dabigatran and apixaban.

In July 2015, the Centre for Adverse Reactions Monitoring (CARM) received a report of hair loss with the use of rivaroxaban. The patient experienced significant and continuously worsening hair loss which was noticed four days after starting rivaroxaban. The patient had no previous history of hair loss.

Review of World Health Organization (WHO) data also suggests that there may be a connection between NOACs and hair loss.

Products Affected

Product name	Sponsor
Rivaroxaban
Xarelto	Bayer
Dabigatran
Pradaxa	Boehringer Ingelheim
Apixaban
Eliquis	Pfizer

NOACs are used in a variety of conditions including:

• Prevention of stroke and systemic embolism.
• Prevention of venous thromboembolism (VTE).
• Treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
• Prevention of recurrent DVT and/or PE.

Additional Information

Hair loss is not a known side effect of the NOACs rivaroxaban, dabigatran or apixaban. However, it is known to occur with the anticoagulants heparin and warfarin. The exact mechanism for hair loss with heparin and warfarin is unknown but is thought to occur through telogen effluvium. Further information on telogen effluvium is available from the DermNet NZ website.

Hair loss through telogen effluvium can be triggered by a variety of conditions as well as fever, surgery, haemorrhage (bleeding), childbirth and medicines. The effects are usually visible around two to four months after exposure to the trigger.

Patients who experience significant and/or worsening hair loss should continue to take their medicine and seek medical advice.

The overall benefit-risk balance of rivaroxaban, dabigatran and apixaban remains positive.

Advice on how to take this medicine and possible side effects can be found in the consumer medicine information (CMI) and data sheet

Search for consumer medicine information

Search for data sheet information

Regulator Actions

Medsafe is placing this safety concern on the medicines monitoring () scheme to obtain further information on these possible adverse reactions.

Please report any suspected adverse reactions, particularly hair loss, with rivaroxaban, dabigatran and apixaban. Please include information on time to onset of hair loss, the relevant medical history and course of the disease.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).

Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

Update to Original Communication

7 February 2017

During the medicines monitoring period (30 May 2016 to 31 December 2016), no further cases were reported to the Centre for Adverse Reactions Monitoring (CARM). The safety concern has been investigated and no link between rivaroxaban, dabigatran and apixaban and hair loss was demonstrated. The balance of the benefits and risks of harm for rivaroxaban, dabigatran and apixaban remains positive and no further action is required at this time.

Medsafe will re-investigate this concern should more information become available.