Pfizer Canada, which is responsible for the manufacture of Mylan’s EpiPen product, told Health Canada that this is due to manufacturing issues with the EpiPen 0.3mg format.
As a result, Pfizer revealed that new supply to pharmacies across Canada will not resume until the end of August, according to Health Canada’s press release.
The service announced, “This means that while some pharmacies may currently have some inventory on-hand, it will likely be depleted in the coming days or weeks.”
The issue has been on-going for some time, after Pfizer subsidiary Meridian Medical Technologies received a warning letter from the US Food and Drug Administration (FDA) in September 2017. When the issues were last reported, it was thought the issue would be resolved by March, with Pfizer noting that the warning letter was not anticipated to impact supply.
A Pfizer spokesperson responded to a request for comment by stating: “We understand how important this potentially life-saving product is to patients, and are working tirelessly to increase production and expedite shipments as rapidly as possible.”
The spokesperson continued, “Currently, supplies may vary from pharmacy to pharmacy, and we are working closely with Mylan to meet their global supply needs during this tight supply situation.”
EpiPen injectors are used to deliver adrenaline (epinephrine) to patients who are experiencing a life-threatening allergic reaction, known as anaphylaxis.
According to Mylan, each new EpiPen should have a minimum of 12 months before expiry when received and expire 18 months on from the date of manufacture. This means that those who require the product need access to a regular supply of medication.