Summary Safety Review - Halaven (eribulin mesylate) - Assessing the potential Risk of severe skin side effects

March 12, 2018

Product

Halaven (eribulin mesylate)

Potential Safety Issue

Severe skin side effects (Severe Cutaneous Adverse Reactions, SCAR), which include: Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP), and Drug Reactions with Eosinophilia and Systemic Symptoms (DRESS).

Key Messages

  • Halaven is a prescription drug that is authorized for sale in Canada to treat some types of breast cancers and soft-tissue cancers (liposarcomas).
  • Health Canada reviewed the risk of rare severe skin side effects (Severe Cutaneous Adverse Reactions, SCAR) with the use of Halaven because a case of a skin side effect (erythema multiforme) that could potentially have been a case of SCAR had been reported in Canada.
  • Health Canada's review of the available information did not find enough information to make a direct link between the use of Halaven and the potential risk of SCAR. Health Canada concluded that the current product safety information covers the potential risk of SCAR and that no additional warnings are required. Health Canada will continue to monitor the safety of Halaven.

Overview

Health Canada reviewed the potential risk of SCAR with the use of Halaven because reports of a skin side effect (erythema multiforme) that could potentially have been a case of SCAR had been noted in Canada. The safety review focused on a specific set of side effects which included: Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP), and Drug Reactions with Eosinophilia and Systemic Symptoms (DRESS). While rare, these side effects can lead to hospitalization and death in some cases.

Use in Canada

  • Halaven is a prescription drug that is authorized for sale in Canada to treat certain types of breast and soft-tissue (liposarcomas) cancers.
  • Halaven has been marketed in Canada since 2012.

Safety Review Findings

  • A search for cases of SCAR in the Canada Vigilance database uncovered a report of a skin side effect (erythema multiforme) that could potentially have been a case of SCAR, which prompted a broader search. Given the seriousness of the SCAR conditions, a safety review was triggered, however, no Canadian reports of SCAR were found. This safety review looked at 22 international cases of SCAR with the use of Halaven from the manufacturer's global safety database. Of these 22 cases, 17 were excluded from further review as they either did not have enough information, were not found to be related to SCAR, or there were other medications used by the patient that may have caused SCAR. The remaining 5 cases were found to be possibly linked to the use of Halaven. Among these 5 cases, there was 1 death which could not be linked to Halaven because there was not enough information.
  • There was no published literature which suggested a direct link between Halaven and the potential risk of SCAR.
  • Both SJS and TEN have already been included in the product safety information by Health Canada, the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA).
  • Overall, there was not enough evidence to suggest a direct link between Halaven and the potential risk of SCAR.

Conclusions and Actions

  • Health Canada's review concluded that there was not enough evidence to establish a direct link between the use of Halaven and the potential risk of SCAR. The current product safety information covers the potential risk of SCAR and no additional warnings are required.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of this health product.
  • Health Canada will continue to monitor safety information involving Halaven, 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 information and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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