New warnings about the risk of potential heart problems have been added to the Consumer Medicine Information (CMI) and Product Information (PI) documents for donepezil.
Donepezil is used to treat Alzheimer's disease but can also affect the cardiac conduction system – the network of signals that keeps the heart beating. It is marketed in Australia as Aricept and various generic brands.
It has been identified that a potentially serious cardiac conduction problem called QTc prolongation can occur with use of this medicine. QTc prolongation is where the heart muscle takes longer than normal to recharge between beats.
The PI for donepezil, which includes information for health professionals, has been updated with warnings for people taking this medicine who:
- have QTc prolongation
- have a family history of QTc prolongation
- are taking other medicine that also causes QTc prolongation (see 'Information for health professionals' below)
- have certain heart problems, such as heart failure, a recent heart attack or bradyarrhythmia (a slow heart rate and irregular heart rhythm)
- have electrolyte disturbances (low blood levels of potassium and magnesium, which can also affect heart function).
Information about this safety risk has also been added to the CMI for consummers.
Information for consumers
If you or someone you care for is taking donepezil to treat Alzheimer's disease, please be aware of this issue. Check the list above and talk to your health professional if any of these points apply. Also check if you or they are also taking any of the following medicines, which are known to prolong the QTc interval:
- some medicines for heart rhythm problems, e.g. amiodarone, sotalol, disopyramide
- some medicines for depression, e.g. citalopram, escitalopram, amitriptyline
- some medicines for psychosis, e.g. chlorpromazine, prochlorperazine, pimozide, ziprasidone
- some medicines for bacterial infections, e.g. clarithromycin, erythromycin, moxifloxacin).
This information is available in full in the CMI for donepezil.
If you have any questions or are not sure whether any of these conditions or medicines apply in your situation, talk to your health professional.
Information for health professionals
If you are a prescriber treating patients with donepezil, please note that cases of QTc interval prolongation and Torsades de Pointes have been reported for this medicine and that the PI has been updated accordingly.
The updates also advise caution when donepezil is used in combination with other medicines known to prolong the QTc interval, including:
- class IA antiarrhythmics, e.g. disopyramide
- class III antiarrhythmics, e.g. amiodarone, sotalol
- certain antidepressants, e.g. citalopram, escitalopram, amitriptyline
- other antipsychotics, e.g. phenothiazine derivatives, pimozide, ziprasidone
- certain antibiotics, e.g. clarithromycin, erythromycin, moxifloxacin.
Clinical monitoring may be required in these cases.
Read the Medicines Safety Update article for more detailed information about the new warnings.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.