Summary Safety Review - Intravenous Methylprednisolone - Liver Injury

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2015-06-18

Product

Intravenous Methylprednisolone

Potential Safety Issue

Liver injury

Key Messages

  • Methylprednisolone is a corticosteroid drug typically used for its anti-inflammatory effects. Administration into a vein (intravenous) is generally only used for short periods in severe inflammatory conditions.
  • A safety review was initiated following the identification of 28 published international cases of liver injury associated with intravenous methylprednisolone, some of which had a fatal outcome.
  • The Canadian prescribing information for intravenous methylprednisolone products marketed under the brand names of SOLU-MEDROL and SOLU-MEDROL ACT-O-VIALS has been updated to include the risk of liver injury. Manufacturers of generic versions of this drug will be asked by Health Canada to update their product information.

Overview

A safety review was initiated following the identification of 28 published international cases of liver injury associated with intravenous methylprednisolone. Among these cases, four had a fatal outcome.

Use in Canada

  • Intravenous methylprednisolone is marketed under the brand names of SOLU-MEDROL and SOLU-MEDROL ACT-O-VIALS. Generic versions of this drug are also available in Canada.
  • Intravenous methylprednisolone is an anti-inflammatory steroid mainly used in hospitals for short periods to treat severe inflammatory conditions. Symptoms of inflammation are often seen with allergic reactions, intestinal disorders (ulcerative colitis), and organ transplants.

Safety Review Findings

  • Up until December 31, 2013, three Canadian reports were received through the Canada Vigilance Programa. Only one case of liver injury was possibly associated with intravenous methylprednisolone.
  • Among the 28 cases identified in the literature, the time to onset of the liver injury varied from several days to several months. Of these cases, 27 were considered severe, and death was reported in 4 cases. Patients' signs and symptoms of liver injury improved when the treatment was stopped in 22 of these 28 cases. When intravenous methylprednisolone was restarted, liver injury reappeared in almost half of the cases.

Conclusions and actions

  • Evidence of an association between intravenous methylprednisolone with a variable time to onset and the occurrence of liver injury was found by Health Canada. The Canadian prescribing information for the products marketed under the brand names of SOLU-MEDROL and SOLU-MEDROL Act-O-VIALS have been updated to better reflect the available evidence regarding the risk of liver injury. Manufacturers of generic versions of this drug will also be asked by Health Canada to update their product information.
  • Health Canada had published an article in the October 2014 Canadian Adverse Reaction Newsletter (CARN)b/sup> to communicate the risk of liver injury associated with intravenous methylprednisolone. This publication is intended to raise awareness among healthcare professionals and to encourage the reporting of similar adverse reactions.

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.

For additional information, contact the Marketed Health Products Directorate.

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Adverse Reaction Database.
  2. As of January 2015, CARN has now become a monthly publication called Health Product InfoWatch

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