Summary Safety Review - OCTAGAM 5% and OCTAGAM 10% (Immune Globulin Intravenous [Human]) - Assessing Lack of Effectiveness and Safety Issues Related to the Manufacturing Process
September 29, 2015
Octagam 5% and Octagam 10% (Immune Globulin Intravenous [Human])
Potential Safety Issue
Lack of effectiveness and safety issues related to the manufacturing process
- Octagam 5% is used to prevent infections in patients with immune system deficiencies. Octagam 10% is used to treat patients who have a blood disorder with decreased numbers of platelet cells, which are required for blood clotting.
- Health Canada conducted an in-depth safety review using additional information requested from the manufacturer of Octagam 5% and Octagam 10%. This was triggered after a routine Health Canada review of information provided by the manufacturer identified both a lack of effectiveness and safety issues related to the manufacturing process, such as allergic reactions (hypersensitivity) and abnormal blood clotting (thromboembolic events).
- Health Canada's safety review found no evidence linking Octagam 5% or Octagam 10% to a lack of effectiveness or to an increase in allergic reactions and abnormal blood clotting. The risk of allergic reactions and abnormal blood clotting is known for these medicines and is already described in the Canadian prescribing information. Health Canada will continue to monitor safety information associated with Octagam 5% and Octagam 10%.
Use in Canada
- Octagam 5% is authorized to help prevent infections in patients with immune system deficiencies. Although not sold in Canada, Octagam 5% was included as part of the safety review to help determine if there were safety issues.
- Octagam 10%, sold in Canada since 2013, is authorized to treat patients who have a blood disorder, which decreases their number of platelets (immune thrombocytopenic purpura). Patients with low numbers of platelets may experience increased bruising or bleeding. Octagam 10% can be used to decrease the high risk of bleeding or increase the number of platelets before surgery.
- Octagam 5% and Octagam 10% are reported to be used to treat other immune disorders that are not authorized by Health Canada.
Safety Review Findings
- At the time of the review, no reports of Canadians experiencing a lack of effectiveness with Octagam 5% and Octagam 10% were received through the Canada Vigilance ProgramFootnote a. In addition, there were no reports linking the manufacturing process of these medicines to allergic reactions or abnormal blood clotting.
- In 2010, an increased number of reports of allergic reactions and blood clots were received by the manufacturer of Octagam 5% and Octagam 10%. The manufacturer determined that these safety issues were related to the manufacturing process and linked only to specific lots of Octagam 5% and Octagam 10%. These lots were never sold in Canada. The manufacturer recalled the affected lots and improved the manufacturing process to help prevent future occurrences of these side effects. Since the new manufacturing process was put in place, the frequency of reports of allergic reactions and blood clots has returned to normal.
- A review of Canadian and international case reports, clinical trial reports, and the scientific literature did not find information indicating a lack of effectiveness for these medicines or identify a change in the current safety profile of these products.
Conclusions and Actions
- Health Canada's review did not find information linking Octagam 5% and Octagam 10% to a lack of effectiveness. Health Canada also found no evidence that the safety issues related to the manufacturing process for Octagam 5% or Octagam 10% ever posed a health risk to Canadians.
- The risk of allergic reactions and abnormal blood clotting is known for these medicines and is already described in the Canadian prescribing information for Octagam 5% and Octagam 10%. Health Canada has also issued a notice to hospitals about the link between abnormal blood clotting and products like Octagam 5% and Octagam 10%.
- Health Canada will continue to monitor side effect information involving Octagam 5% and Octagam 10%, as it does for all health products on the Canadian market, to find and study potential harms. Health Canada will take the right and timely action if and when any new health risks are identified.
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.
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