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.