Other safety alerts
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| Canada: Summary Safety Review - HMG-CoA Reductase Inhibitors (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin) - Statins - Assessing the Potential Risk of Myasthenia Gravis, Including Ocular Myasthenia |
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Health Canada announces that it reviewed the potential risk of myasthenia gravis, including ocular myasthenia, with the use of statins. The safety review was triggered by a labelling update for all statin products by the European Medicines Agency.
Statins are prescription drugs authorized for sale in Canada, to be used along with diet, to lower cholesterol and triglyceride (fat) levels in the blood, and to reduce the risk of heart attack or stroke in patients with risk factors for heart problems.
At the time of this review, the manufacturers of 2 Canadian statin products, Crestor (rosuvastatin) and Zocor (simvastatin), initiated a labelling update to include the risk of myasthenia gravis, including ocular myasthenia, in their respective CPMs. The purpose of this review was to determine whether this risk is associated with all statin products, warranting labelling updates across the drug class.
Health Canada reviewed the available information provided by manufacturers, and from searches of the Canada Vigilance database, international databases and the scientific literature. Health Canada reviewed 31 cases (2 Canadian and 29 international) of myasthenia gravis and/or ocular myasthenia in patients taking statins. Of the 31 cases, 27 (1 Canadian) were found to be possibly linked to the use of statins, 1 was unlikely to be linked and 3 (1 Canadian) could not be assessed due to missing information. Of the possible cases, 3 had recurrence of symptoms of myasthenia gravis and/or ocular myasthenia when treated with different statins, which suggests a drug class-effect for this risk.
Health Canada also reviewed 4 studies published in the scientific literature. Despite limitations, the studies provided evidence supporting a link between statins and worsening myasthenia gravis and/or ocular myasthenia. Evidence of a link between statins and new occurrence of myasthenia gravis and/or ocular myasthenia in published studies was limited; however, published case reports supported a possible link.
Health Canada’s review found a possible link between statins and the risk of myasthenia gravis, including ocular myasthenia, and that this is a class-effect. Health Canada will work with the manufacturers to include the risk of myasthenia gravis, including ocular myasthenia, in the CPM for statin products that do not currently include this risk.
Please refer to the following website in Health Canada for details:http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1732733593751
In Hong Kong, there are registered pharmaceutical products containing atorvastatin (94 products), lovastatin (3 products), pravastatin (8 products), rosuvastatin (71 products) and simvastatin (81 products). All products are prescription-only medicines. There is no registered pharmaceutical product containing fluvastatin or pitavastatin.
So far, the Department of Health (DH) has received adverse drug reaction related to atorvastatin (22 cases), rosuvastatin (20 cases) and simvastatin (8 cases), but these cases were not related to myasthenia gravis. The DH has not received any case of adverse drug reaction related to lovastatin and pravastatin. Letters to inform local healthcare professionals was issued on 27 Sep 2023.
In Feb 2024, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and the Committee decided that the sales pack label and/or package insert of statins-containing products should include the relevant safety information. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/ Saturday, February 1, 2025
Issued at HKT 14:00
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