Defective EpiPens have been cited in seven deaths this year so far, according to reports made to the FDA and obtained by Bloomberg News.
During the same period, the FDA has received 228 reports of EpiPen failures and at least 35 people were hospitalized as a result of those failures.
Failure reports for Mylan‘s (NSDQ:MYL) life-saving emergency allergy treatment have been growing in numbers over the past few years. In 2012, there four reports of device failures to the FDA. In the following year, there were 12 reports, according to Bloomberg News. And in 2014, that number jumped to 67.
In September, FDA investigators sent a warning letter to EpiPen manufacturer Meridian Medical Technologies, saying that inspectors found “significant violations of current good manufacturing practice requirements for combination products,” including issues relating to quality control procedures, product complaint resolution and design verification.
In some cases, investigators found that epinephrine was leaking out of the devices. The FDA also said that it found that the injector failed in some EpiPens during its inspection.
MYL shares fell -4% yesterday and were trading at $34.75 in premarket activity today, down -1.7%.
“We are not aware of defective EpiPens currently on the market and recommend that consumers use their prescribed epinephrine auto injector,” the FDA told Bloomberg News. “We have seen circumstances in which adverse events reports increase once a safety issue is publicized, like a recall. We continue to monitor and investigate the adverse event reports we receive.”