Published: 3 March 2016
Revised: 17 October 2016

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.

Ticagrelor (Brilinta) and a possible association with depression / suicidality added to the Medicine Monitoring scheme

1 March 2016

Monitoring finishes 30 September 2016

Reports in the World Health Organisation’s database from New Zealand and from various other countries may suggest a possible safety concern regarding ticagrelor and depression / suicidality.

Suicidality includes suicidal thoughts and tendencies, thoughts of self-harm and self-harm.

Products Affected

There is currently one product containing ticagrelor approved for use in New Zealand.

Product name	Sponsor
Brilinta 90 mg film coated tablet	AstraZeneca Limited

Brilinta, co-administered with acetylsalicylic acid (aspirin), is indicated for the prevention of blood clots in adult patients with acute coronary syndromes (such as unstable angina and myocardial infarction (heart attack)).

Additional Information

Depression / suicidality are not known side effects of ticagrelor. Patients who have had a heart attack are more likely to be depressed than the general population.

Patients who experience feelings of depression or suicidality should seek medical advice immediately.

The overall benefit-risk balance of ticagrelor 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 with ticagrelor, in particular depression / suicidality.

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

13 October 2016

During the medicines monitoring period (1 March 2016 to 30 September 2016), no further cases were reported to the Centre for Adverse Reactions Monitoring (CARM). The safety concern has been investigated and no link between ticagrelor and depression / suicadality was demonstrated.  The balance of the benefits and risks of harm for ticagrelor remains positive and no further action is required at this time.

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