Canada Updates Statin Labeling On Muscle Toxicity, Adds Predisposing Factors
This article was originally published in The Pink Sheet Daily
Health Canada universalizes statin safety labeling; warning adds list of predisposing factors for rhabdomyolysis and myopathy. Lists are similar to U.S. labeling, but not identical.
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Citizen petition supplement pushes for a warning, similar to that carried on statin drugs in Canada, about the risk of CoQ10 depletion. Petitioner seeks a statement that CoQ10 deficiency “is associated with impairment of myocardial function, with liver dysfunction, and with myopathies.”
Roche will consider requesting a re-examination of the negative decision by the Committee for Medicinal Products for Human Use.