Summary Safety Review - REVOLADE (eltrombopag) - Serious Skin Reactions
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: 2015-09-10
Product
Revolade (eltrombopag)
Potential Safety Issue
Serious skin reactions
Overview
Use in Canada
- Revolade (eltrombopag) is a medicine used to help increase the number of platelets or thrombocytes in the following conditions: immune thrombocytopenia purpura, severe aplastic anemia and hepatitis C virus infection. Immune thrombocytopenia purpura is a condition in which patients produce proteins (antibodies) that destroy their platelets. Severe aplastic anemia is a condition in which patients produce antibodies that destroy their white and red blood cells. Hepatitis C virus is known to cause a decrease in blood platelet counts (thrombocytopenia).
- Patients with low platelets may bruise or bleed easily and patients with low white and red blood cells are prone to serious infections and fatigue.
- Revolade is administered orally as tablets and it has been marketed in Canada since April 4, 2011.
Safety Review Findings
- In this safety review, the term "serious skin reactions" included cases of:
- Stevens-Johnson Syndrome (SJS), a rare and serious disorder of the skin and mucous lining.
- Toxic Epidermal Necrolysis (TEN), the disease that causes the top layers of skin to detach from the lower layers of the skin leading to a severe infection.
- Drug Reaction with Eosinophilia and Systemic Reactions (DRESS), a syndrome caused by a severe and unexpected allergic response following exposure to certain medications.
- Any other serious skin reactions other than SJS, TEN or DRESS.
- At the time of the review, Health Canada had received two reports of serious skin reactions other than SJS, TEN or DRESS in Revolade usersa. Similar international reports suspected to be linked with Revolade use were provided by the company that first marketed Revolade.
- A review of the scientific and medical literature found two research articles describing four cases of serious skin reactions linked with Revolade use. No cases of SJS, TEN or DRESS were identified in Canada or internationally.
- Health Canada assessed these cases and concluded that the evidence of risk of serious skin reactions in Revolade users was limited by many factors primarily including that some reports were incomplete and that patients were taking other medications at the same time as Revolade.
- The Canadian prescribing information for Revolade already describes that rashes and the abnormal loss of skin cells (exfoliation) can occur.
Conclusions and actions
- Health Canada's safety review concluded that the evidence did not support a link between the use of Revolade and risk of serious skin reactions.
- The risk of rashes and skin exfoliation is already included in the Canadian prescribing information for Revolade.
- Health Canada will continue to monitor adverse reaction information involving Revolade, as it does for all health products on the Canadian market, to find and study potential harms. Health Canada will take the appropriate and timely action if and when any new health risks are identified.
Additional information
The analysis that was carried out for this safety review took into consideration information from scientific and medical literature, Canadian and international adverse reaction reports as well as what is known about the use of this drug in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.
Footnotes
- Canadian reports can be accessed through the Canada Vigilance Adverse Reaction Database.