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|Articles|January 30, 2018

Pfizer Canada Announces EpiPen Shortage

A manufacturing disruption has led to an EpiPen shortage in Canada, which currently has no alternative auto-injectors available on the market.

In a Jan. 11, 2018 press statement, Pfizer Canada announced that it is experiencing a shortage of EpiPen auto-injectors in the 0.3 mg format.

EpiPen is used to deliver an emergency treatment of adrenaline (epinephrine) to patients who are at risk or have a history of life-threatening allergic reactions (anaphylaxis). According to Health Canada, the department responsible for Canadian public health, there are currently no alternative auto-injectors available on the market in Canada.

The shortage, caused by a manufacturing disruption at a Pfizer facility, is expected to be resolved by March 2, 2018, according to Health Canada. Currently, there is limited supply of auto-injectors at wholesalers, distributors, and pharmacies. Pfizer, which contract manufactures the EpiPen device for generic firm, Mylan, the marketer of the EpiPen drug, expects a period of between two and four weeks of no inventory while working to avoid long-term supply shortage, as stated by the company in its press statement.

Additional limited inventory will be supplied at the beginning of February 2018, which will be placed under allocation, according to Pfizer. The company also stated that the shortage does not impact EpiPen Jr. (0.15 milligrams), which remain available.

This shortage is another event in a series of recent issues involving EpiPen. In September 2017, FDA issued a warning letter to Pfizer’s Meridian Medical Technologies facility, located in Brentwood, MO, which manufactures Mylan’s EpiPen (epinephrine injection). The warning letter identifies significant violations of current good manufacturing practice (cGMP) requirements for its epinephrine auto injectors, including EpiPen and EpiPen Jr.

In March 2017, FDA announced that Meridian Medical Technologies expanded a voluntarily recall to include 13 lots of Mylan’s EpiPen and EpiPen Jr. in the United States due to a potential defective part. Mylan said the defective part may cause activation failure in the autoinjectors. In a statement, Mylan said the recall, which began in Australia, also extended to parts of Europe, Asia, and North and South America.

Source: Pfizer Canada, Health Canada

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