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.

Like this


10 September 2017
Notable Buzzer: Fiat Chrysler Automobiles NV (FCAU)
FCAU generated revenue of $0 in the same quarter, one year ago. (The) in a research note issued to investors on Friday. The company had revenue of $27.93 billion for the quarter, compared to analyst estimates of $29.24 billion.

10 September 2017
Democratic Senators Attack Catholic Judicial Nominee Over Religion
It cites a law review article Barrett co-wrote with John Copeland Nagle a year ago , which says. something different. Court of Appeals for the Seventh Circuit, sounds like a nasty swipe at the prospective judge's Catholic faith.

10 September 2017
Unlocked Samsung Galaxy S8 Active Gets Certified By The WiFi Alliance
Like the S8 Active, its unlocked edition will be coming with same specs as Galaxy S8 but may come with a different design. The Galaxy S8 Active is available in unique colors like Meteor Gray and Tungsten Gold.

10 September 2017
Opioid maker bent rules to get drug to patients, Senate report says
Wednesday's report is part of a broader probe into opioid manufacturers including Purdue, Johnson & Johnson, Mylan, and Depomed. To work around that, Insys allegedly called insurance companies and tricked them into okaying the drug for non-cancer patients.

10 September 2017
New Mouseketeers Debut in 'Social-First' 'Mickey Mouse Club' Revamp
The new Mouseketeers are true digital-first creators, selected with talent, authenticity, and attainability in mind. Leanne Tessa Langston (@leannetessa_) - Leanne Tessa Langston , 17, is an aspiring singer, songwriter, and dancer.

10 September 2017
Titans: Hawk And Dove Reportedly Cast
Dove: aka Dawn Granger , is one half of the crime-fighting, vigilante duo and romantic couple Dove and Hawk. Deadline is reporting that Alan Ritchson and Minka Kelly have been cast as Hawk and Dove .

10 September 2017
Florida Airports Stall As Too Many Flights All Try To Leave
Under the law, they can be held up to 72 hours before the state would have to go to court to prolong their detention. ET Saturday, Hurricane Irma had maximum sustained winds of 120 miles per hour , the National Hurricane Center said.

10 September 2017
NIA moves against aides of separatists
Kashmir conflic "We will permit them to go to Delhi if they wish to go individually", a senior police officer told Kashmir Life. A number of delegations from civil society are meeting him, officials said.

10 September 2017
NA Maintains Stake in Caterpillar, Inc. (CAT)
Lastly, BidaskClub lowered Caterpillar from a buy recommendation to a hold recommendation in a study note on early Mon, Jul 24th. Finally, Geode Capital Management LLC grew its position in shares of Caterpillar by 8.1% during the 1st quarter.

10 September 2017
Atlanta Falcons at Chicago Bears - 9/10/17 NFL Pick, Odds, and Prediction
The defense hopes to continue their ascent behind some emerging stars like pass rusher Vic Beasley. On the offensive side of the ball, you know what to expect from the Falcons.