Insulin Products in Canada
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The Issue
Animal-sourced and human biosynthetic insulins are used worldwide for controlling diabetes. Recently there have been concerns regarding the availability of animal-sourced insulins for those patients who have difficulty using human biosynthetic insulin.
Background
Generally speaking, there are two types of insulin: animal-sourced insulin, and biosynthetic human insulin. Historically, preparations of beef, pork and beef-pork insulins were used for managing diabetes. These animal-sourced insulins have been used safely for many years, and are still being used safely.
The first genetically engineered human insulin, called biosynthetic human insulin or recombinant or DNA-derived insulin, was manufactured by Eli Lilly and approved for sale in Canada in 1983. In 1993, another biosynthetic human insulin made by Novo Nordisk was approved. Prior to approval and sale in Canada, a thorough review of the products' effectiveness, safety and quality was done. The conclusion was that human biosynthetic insulins could be used as safely as animal-sourced insulins.
Understanding Possible Reactions to Insulin
When biological matter such as insulin is introduced into the human body, the body may recognize it as foreign and begin manufacturing antibodies to fight it. In some cases, this process results in the person having to take more insulin to control their diabetes. While animal-sourced products are more likely to induce antibodies, a recent review of the major studies on insulin indicated that the safety and effectiveness of human biosynthetic insulins and those of animal-sourced insulins were comparable.
Although the vast majority of people with diabetes use human biosynthetic insulins successfully without any problems, in the past few years, a small number of individuals have reported difficulties. Some individuals reported experiencing hypoglycemia (low blood sugar) without clearly recognizable symptoms, and wide and sudden swings in blood sugar levels, which lead to increased difficulty controlling their diabetes. The reasons for these difficulties are still unclear.
Insulin Availability
In addition to the original human biosynthetic insulins made by Eli Lilly and Novo Nordisk, newer, modified versions are now approved for sale in Canada. Rapid acting insulins are sold by these companies and a basal or long-acting insulin by Aventis Pharma has been approved, but is not yet sold in Canada.
There have been concerns that some doctors may not be aware that animal-sourced insulin is still available in Canada. As a result of changing demands in their markets, Eli Lilly and Novo Nordisk have stopped selling beef-pork insulin world-wide, but Eli Lilly still supplies pork insulin in Canada. This company has indicated that it is committed to making pork insulin available in Canada and elsewhere. Beef insulin can be imported from a source in the United Kingdom through Health Canada's Special Access Programme (SAP).
Minimizing Your Risk
The harder it is for you to control your blood sugar, the more likely you are to suffer a variety of reactions not only to your disease, but also to your insulin. Take the following steps to help manage your diabetes:
Consult with your doctor: Work closely with your doctor when deciding on the most appropriate insulin treatment. Ask about all the possible symptoms of low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia), and how to manage both effectively.
Recognize the symptoms of hypoglycemia: All insulins can result in hypoglycemia under these conditions:
- when food is not balanced with insulin
- when you have had too much activity and not enough food
- if the dose taken is more than your body needs at the time
- if you are changing your regime and insulins
It is important that you understand why low blood sugar may occur, what to do about it and how to prevent it in the future. Symptoms and signs of hypoglycemia can vary from person to person, and can sometimes be very subtle, atypical and hard to recognize, regardless of the type of insulin you use. Your ability to recognize low blood sugar may change over time.
Your doctor can help by suggesting strategies to deal with this problem. You can also play an active role by ensuring that you regularly monitor your blood glucose. Symptomatic hypoglycemia can lead to fatigue, sweating, disturbed behaviour, hunger, loss of consciousness or even death.
Know your insulin: There are many different insulin products available in Canada and some of these products have similar looking and sounding names. Therefore, it is important for you to be sure that you are using the insulin recommended by your doctor.
Health Canada's Role
Health Canada monitors adverse events associated with taking insulins. Along with other advantages, reporting adverse reactions helps to identify trends, and this information is shared with health care professionals and consumers. Information collected from individuals also plays a part in updating product information, when appropriate.
The patterns and numbers of adverse events reported with human and animal insulin have been found to be similar given the differences in the numbers of patients using the products.
Need More Info?
To report all adverse reactions with the insulin you are currently taking, contact:
Adverse Reaction Information Section
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate, Health Products and Food Branch, Health Canada
Tunney's Pasture, Locator 0201C1
Ottawa, Ontario, K1A 1B9
Tel: (613) 957-0337 or Toll-free: 1-866-234-2345
Fax: (613) 957-0335 or 1-866-678-6789
or visit: Adverse Reaction Information Section
To import approved insulins from other countries, contact:
Health Canada's Special Access Programme (SAP)
Tel: (613) 941-2108
For more information about diabetes, visit:
Additional It's Your Health articles can be found at: www.healthcanada.ca/iyh
You can also call (613) 957-2991
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