Summary Safety Review - AVONEX (interferon beta-1a) - Assessing the Potential Risk of Kidney Damage (nephrotic syndrome)
June 30, 2016
Avonex (interferon beta-1a)
Potential Safety Issue
Kidney damage (nephrotic syndrome)
- Avonex is used to treat some forms of multiple sclerosis, a disease affecting the central nervous system.
- This safety review was carried out by Health Canada after the European Medicines Agency requested that all interferon beta manufacturers include the risk of nephrotic syndrome in the prescribing information for these products.
- Health Canada’s safety review concluded that there is a potential risk of nephrotic syndrome with the use of Avonex. Health Canada has therefore asked the manufacturer to update the Canadian prescribing information for Avonex to include this risk.
Health Canada carried out a safety review to look into the potential risk of nephrotic syndrome with the use of Avonex. This issue was raised when the European Medicines Agency requested that the risk of nephrotic syndrome be included on the label for all interferon beta products.
Nephrotic syndrome includes symptoms of kidney damage, such as protein in the urine, low levels of protein in the blood, high cholesterol levels, and swelling.
Use in Canada
- Avonex is used to treat some forms of multiple sclerosis, to reduce damage to the central nervous system, and to slow down the worsening of the disease. Avonex is given by injection into the muscle at a dose of 30 micrograms once a week.
- Avonex has been sold in Canada since December 2005. It is available by prescription only.
Safety Review Findings
- At the time of the review, there was only 1 Canadian case of nephrotic syndrome reported in a multiple sclerosis patient using Avonex.
- A search in the World Health Organization’s Adverse Drug Reaction Database found 10 cases of nephrotic syndrome reported in multiple sclerosis patients treated with interferon beta products.
- In the scientific and medical literature, there were 7 cases of nephrotic syndrome found with the use of interferon beta products.
- In addition, the manufacturer shared a report from the Global Safety Database which contained 9 cases of nephrotic syndrome with Avonex. Upon review of these cases, they were considered to be possibly related to the use of Avonex.
- Information regarding the risk of nephrotic syndrome is already included in the prescribing information for all other interferon beta products in Canada (i.e., Betaseron, Rebif, and Extavia). Information on the risk of nephrotic syndrome appears in the European product labelling for all interferon beta drugs.
Conclusions and Actions
- Health Canada’s safety review concluded that there is a potential risk of nephrotic syndrome with the use of Avonex for the following reasons:
- nephrotic syndrome has been linked to other interferon beta drugs;
- nephrotic syndrome has been reported with Avonex treatment;
- Avonex causes changes in the body which might bring about nephrotic syndrome as a side-effect;
- Health Canada has asked the manufacturer to update the Canadian prescribing information to include this risk.
- Health Canada continues to monitor side effect information involving Avonex, 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.
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.
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