Published: 3 March 2016
Revised: 17 October 2016
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.
There is currently one product containing ticagrelor approved for use in New Zealand.
|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)).
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.
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.
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.
Medsafe will re-investigate this concern should more information become available.