Pro Doc Limitée has initiated a recall of a specific lot of Donepezil (donepezil hydrochloride) 10 mg tablets, citing concerns that certain bottles may contain oversized tablets. Health Canada is cautioning patients and their caregivers about the potential risks associated with taking an oversized tablet, which could result in receiving up to three times the intended dose (30 mg), posing serious health threats.
Donepezil is a prescription medication prescribed for the symptomatic treatment of mild, moderate, and severe Alzheimer's disease.
An abrupt increase in the dosage of Donepezil or exceeding the recommended daily limit of 10 mg/day may lead to or exacerbate common adverse effects such as nausea, diarrhea, vomiting, fatigue, loss of appetite, insomnia, and muscle cramps. Clinical trials generally indicate a higher frequency of adverse events with advancing age and in female patients. Cardiovascular adverse events, including a slow heartbeat, heart block (a type of heart arrhythmia), or loss of consciousness, are more prevalent in individuals taking higher doses and may occur with or without known underlying cardiovascular conditions. Immediate medical attention is crucial for patients exhibiting symptoms of neuroleptic malignant syndrome while on Donepezil, such as high fever, muscle stiffness, irregular blood pressure, pulse or heartbeats, confusion, agitation, or coma.
Exceeding the recommended doses of Donepezil can lead to a cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, slow heartbeats, low blood pressure, reduced breathing, loss of consciousness, and convulsions. Increased muscle weakness is a potential outcome and may result in fatality if respiratory muscles are affected.
Health Canada is closely monitoring the recall initiated by the company and assessing the implementation of any necessary corrective and preventive measures to mitigate the risk of recurrence. The Department will promptly communicate any newly identified health risks to the public.