Cough and Cold Products Containing Opioids and the Risk of Opioid Use Disorder in Children and Adolescents (< 18 years of age)
In 2019, Health Canada published a summary of a safety review of opioid-containing products indicated for cough and cold, which found limited evidence to support the effectiveness of these products in children and adolescents (under 18 years of age). The review also found limited evidence to link these products with opioid use disorders and related harms in children and adolescents (under 18 years of age). As a precautionary measure, Health Canada has now limited the use of opioid-containing products indicated for cough and cold for adults only (patients 18 years of age and older) and has notified manufacturers of these products to update the indication and other relevant sections of the CPMs to include this new safety information.
Sandoz Canada has decided not to pursue its submission for biosimilar filgrastim (Zarxio®) in Canada at this time. This decision is due to specific requirements from Health Canada that were not present in our initial application. Zarxio is our proposed formulation of filgrastim and is being developed by Sandoz as an important treatment option for Canadian patients with neutropenia.
We are disappointed with this setback in bringing Zarxio to Canadian patients. With 10 years of experience around the globe, we are confident that Zarxio is a product that meets stringent safety, efficacy and quality standards. It was approved by the European Commission (in 2009) and the FDA (in 2015) and is currently marketed in 86 countries, accounting for over 27 million filgrastim patient exposure day1
We remain committed to bringing this product to patients in Canada and we are evaluating how to best meet the requirements of Health Canada. We are determined to work closely with them to make this a reality as soon as possible.
Furthermore, we stand behind our commitment to bringing high-quality biosimilar medicines to Canadian patients to help fulfill their unmet needs