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FDA: Hundreds of Complaints Received About Misfiring EpiPens

FDA: Hundreds of Complaints Received About Misfiring EpiPens”

A spokesperson for Mylan told CNBC: "Pfizer is continuing to work with FDA to resolve the points raised in the letter regarding Pfizer's manufacturing of EpiPen Auto-Injector, and Mylan will do whatever it can to support this process".

The Food and Drug Administration sent the manufacturer a warning letter Tuesday, which noted Meridian received 171 complaints between 2014 and 2017 about EpiPens failing to properly activate during emergency situations, "including some situations in which patients subsequently died".

The company did not thoroughly investigate the complaints, nor did it remove "potentially defective products from the marketplace, even though you had identified a defect in one of the critical components used to manufacture the products and even though you ultimately confirmed the same or similar component defect as the root cause for multiple complaints", the FDA said.

It claimed that in some cases people had died after the device, which delivers a dose of epinephrine to people suffering from severe allergic reaction known as anaphylaxis, failed to work properly.

The FDA had inspected the plant several years ago then returned in late February for what turned out to be a month-long look at the facility's manufacturing practices.

Responding to the Daily News, Pfizer said it stood by the devices produced by its manufacturer and make corrections "if and as appropriate".

"It's not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals", according to Bencker.

In the FDA's recent inspection, which took place between February 20 and March 24, it found glaring quality control and current good manufacturing practice (cGMP) violations at Meridian. In a written statement, Pfizer said that "between 2015 and now, we have shipped more than 30 million EpiPen auto-injectors globally".

Within days of the inspection, Mylan began recalling EpiPen devices from the US, as well as Europe, Asia, and North and South America, due to a product defect that, at the time, Mylan claimed "occurs rarely". "You instructed your supplier to undertake a full investigation and corrective actions regarding [EpiPen's] firing defect, but continued to manufacture finished products using other lots of the same component while the supplier's investigation remained open until October 2016".

"We now have no information to indicate that there was any causal connection between these product complaints and any patient deaths", she added.

At the same facility producing the EpiPen, which earlier in the year had been recalled following a pair of reports of the misfiring of the auto-injector devices, when that recall ended, which is in the FDA letter, there were not any reports released to the public of any deaths associated with the use of the EpiPens.

This article has been updated to include Pfizer's statement.

The FDA cited another concerning finding. Finally, the company does not anticipate any supply issues.

"Both problems result in the patient not receiving the needed drug in a life-threatening situation", the FDA wrote.



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