More than a month after Mylan and Pfizer reported to Health Canada that there are new issues affecting some EpiPens, the companies and the FDA notified U.S. healthcare providers of the problem, which can delay treatment when the pens are needed.
Mylan, Pfizer and the FDA reported on Friday that some pens and their authorized generic versions may not easily slide out of their carrier tube and so could delay use of the pens. They said that in a very small number of cases, labels were not fully adhered to the surface of the autoinjector, causing the lifesaving device to become stuck to the inside of the carrier tube. Health Canada made a similar announcement on Sept. 28.
The FDA said it has not learned of any adverse event reports associated with the labeling issue. Pfizer said the risk is low and is not recalling the pens. Instead, it says that if consumers have any of the pens, they should make sure they can slide out of their carriers properly. Pfizer said the problem is only with the labels and that the pens are good to use.
The newest issue arises as Pfizer and Mylan have been working to ramp up supplies of the epinephrine dispensers, which are often used to treat anaphylactic shock from allergic reactions. Spot shortages of the injectors began last year after an FDA inspection found serious problems at the Pfizer plant where they are made and which the FDA laid out in a warning letter.
The FDA took steps in August to mitigate the shortage of the ubiquitous EpiPens by allowing some expired devices to remain on the market another four months. The action came as parents were scrambling to find the devices as their children returned to school.
Pfizer acknowledged at the time that Meridian, the Pfizer subsidiary that manufactures the pens, continues to have "manufacturing constraints," but said it is working with Mylan to improve "consistent availability."
The label-sticking problem may affect EpiPen 0.3 mg (NDC 49502-500-02) and the Authorized Generic (NDC 49502-102-02) products expiring between June 2018 and February 2020 and EpiPen Jr 0.15 mg (NDC 49502-501-02) and the Authorized Generic (NDC 49502-101-02) products expiring between October 2018 and October 2019.