Canada’s drug watchdog is reviewing the company that manufactures a new opioid-based version of fentanyl that the government has deemed safe for use.
The Health Canada investigation is part of the country’s growing battle against the opioid epidemic.
A spokesperson for Health Canada said the regulator is taking a holistic approach to determining the risks and benefits of the fentanyl-based drug.
“While we have no way of knowing how a particular drug may impact health outcomes, we are taking this seriously and will make decisions based on the best available scientific evidence,” the spokesperson said.
The regulator has been grappling with the potential risks of fentanyl-releasing fentanyl patches that are being marketed in the U.S. and elsewhere, and has been warning of potential adverse effects in some patients.
A review by the federal government’s advisory committee on pharmaceutical safety, in 2016, recommended that Health Canada stop approving fentanyl-containing patches for sale in Canada.
That committee also recommended that the drug be removed from the list of opioids deemed safe by the Canadian Pharmacopeia, a body that approves medicines.
The Canadian Association of Pharmaceutical Industries and Associations, the trade group representing the country, has called for the government to reverse the decision.
It said the new fentanyl patches could lead to more deaths and add to the fentanyl epidemic.
The review recommended the government stop marketing and distributing the drugs.
Health Canada is also investigating the safety of another fentanyl-related drug, called nortriptyline, which has been approved for use in Canada but is being sold overseas.
The drugs are approved in only a handful of countries, including the U, U.K., and the U and K.