Summary Safety Review - Rivastigmine (Exelon and generics) - Assessing the Potential Increased Risk of Death

November 9, 2016

Product

Rivastigmine (Exelon and generics)

Potential Safety Issue

Increased risk of death

Key Messages

  • Rivastigmine is used to treat dementia in patients with Alzheimer's or Parkinson's diseases.
  • As part of the review of information provided by the manufacturer, Health Canada assessed whether there was an increased risk of death in patients using rivastigmine by patch, compared to pill or liquid.
  • Health Canada's safety review did not find an increased risk of death in patients taking rivastigmine regardless of formulation used. Health Canada will continue to monitor side effects for this drug and has requested the manufacturer of Exelon to continue to provide information on the use of this product.

Overview

As part of the routine monitoring of side effects for rivastigmine, Health Canada evaluated whether there was an increase in the number of patients that died over the past few years while using the Exelon patch (which is the only transdermal formulation currently available in Canada) compared to patients taking rivastigmine pills or liquid (oral formulations). A safety review was carried out to assess the risk of death with Exelon in all formulations to find out if further actions were needed to manage this issue.

Use in Canada

  • Rivastigmine is used to treat dementia symptoms in patients with Alzheimer's or Parkinson’s diseases.
  • Rivastigmine is mainly used in elderly patients since the risk of Alzheimer's and Parkinson’s diseases increases with age. In Canada, almost 10 million total units of rivastigmine (pills, patches or milliliters of liquid) are sold each year.
  • Exelon has been sold in Canada since 2000. Exelon as patch formulations has been sold in Canada since 2007. The use of the patches has increased over time. In 2014, the patch was the form used by about half of all patients treated with rivastigmine.

Safety Review Findings

  • At the time of the review, Health Canada had received 194 reportsFootnote a of death in patients taking rivastigmine. The patch was used in 39 of these reports, oral formulations (pills or liquid) were used in 113 reports; the remaining reports did not have information on the type of formulation. It is difficult to link an increased risk of death to rivastigmine use, regardless the formulation, because patients using rivastigmine may have additional risk factors for death such as advanced age, having other diseases, or taking other medications at the same time.
  • Based on the information reviewed, the number of deaths reported in patients treated with rivastigmine regardless of formulations remained low and stable between 2011 and 2015.
  • The number of deaths reported among patients treated with rivastigmine was lower than expected in an elderly population with Alzheimer's disease.Footnote 1
  • In the literature, there was no evidence of increased risk of death with rivastigmine use.

Conclusions and Actions

  • Health Canada's safety review did not find an increased risk of death in patients taking rivastigmine regardless of the formulation used.
  • Health Canada has asked the manufacturers of Exelon to continue to provide information on the use of this product.
  • Health Canada will continue to monitor side effect information involving Exelon and its generics, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

Reference

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