Tags: EpiPen | failed | investigate | malfunctions | FDA

EpiPen Maker Failed to Investigate Malfunctions: FDA

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By    |   Monday, 11 Sep 2017 11:35 AM

The FDA sent the manufacturer of EpiPens a warning letter accusing them of not investigating reports of malfunctioning devices, including cases that resulted in death.

The warning letter claimed the FDA received hundreds of complaints from 2014 to 2017 concerning EpiPens that failed to work, and included allegations of an unspecified number of deaths following allergic reactions.

The FDA claimed that Meridian Medical Technologies, which is owned by Pfizer and manufactures EpiPens, didn't properly investigate the complaints involving the mechanism that delivers the medicine or the associated deaths.  

"If your auto-injectors do not operate as expected and deliver the intended amount of epinephrine drug when deployed in emergencies, patients can die or suffer serious illness," the letter stated.

"You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness."

EpiPens deliver epinephrine — adrenalin — to people suffering a severe, life-threatening allergic reaction called anaphylaxis.

Epinephrine opens airways in the lungs, which relieves itching, hives, and wheezing due to an allergic reaction to food, stings, drugs, and other allergens.

According to the New York Times, Pfizer spokeswoman, Kim Bencker released a statement saying her company was "very confident in the safety and efficacy of EpiPen products being produced at the site.

"It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals," she stated.

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

Is your EpiPen safe? Consumer Reports gives five ways to protect yourself from a deadly allergic reaction.

• Check here to make sure your pen hasn't been recalled.

• Carry two pens with you. According to a study from Boston's Children's Hospital, 12 percent of children treated for food allergies needed a second dose of epinephrine.

• Replace your EpiPen before the expiration date listed on the carton. In addition, if the epinephrine isn't colorless, it has degraded and should be replaced.

• Learn how to properly use an EpiPen, and get retrained periodically. A University of Texas study found that 86 out of 102 patients made at least one mistake and more than half made three or more mistakes.

• Get professional help after using an EpiPen since you may need additional treatment.

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The FDA sent the manufacturer of EpiPens a warning letter accusing them of not investigating reports of malfunctioning devices, including cases that resulted in death.The warning letter claimed the FDA received hundreds of complaints from 2014 to 2017 concerning EpiPens...
EpiPen, failed, investigate, malfunctions, FDA
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Monday, 11 Sep 2017 11:35 AM
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