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Sep
14
Sandeep Singh Dhillon
Faulty EpiPen allegedly linked to unanticipated patient deaths; FDA issued warning letter – MIMS Malaysia
Pharma News
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Tanvi Ambulkar

An EpiPen, which involves administering an emergency injection of adrenaline in the event of life-threatening anaphylactic reactions, is typically used to restore blood pressure and volume. Recently, the makers of EpiPen have come under fire – in view of its failure to properly investigate the complaints that the device misfired during life-threatening emergencies; including several instances, whereby patients later died, according to a warning letter issued by the US Food and Drug Administration (FDA).

Manufacturers failed to conduct comprehensive investigation into complaints received

The FDA alleges that, “Our own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.” Despite these deaths and more than a hundred complaints, no formal inquiry was initiated by the manufacturer. Inspections of the manufacturing process in a Missouri plantation by the FDA in February and March revealed that there were “significant violations” committed in manufacturing the device.

Several EpiPens were recalled by Meridian Medical Technologies, a Pfizer company, in March to prevent retailing defective devices to customers. A FDA spokesperson has issued a statement expressing that the agency “was not aware of defective EpiPens currently on the market.” The FDA had issued a warning letter to Meridian Medical Technologies elaborating on the drawbacks of the production process. The letter detailed that the company had “failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness.”

Responding to complaints – here’s what the manufacturing company has to say…

Pfizer insists that the nature of these complaints is expected because the “product is frequently administered by non-medically trained individuals.” In spite of this, the number of complaints lodged by customers should have elicited some form of inquiry into the quality of the products sold. However, Pfizer furthers claims that there is “no information to indicate that there was any causal connection between these product complaints and any patient deaths.”

Pfizer has been responsible for shipping up to 30 million EpiPens since 2015. Kim Bencker, a spokesperson for the company, echoes the beliefs of the manufacturer by stating that Pfizer was “very confident in the safety and efficacy of EpiPen products being produced at the site.” Whilst it is difficult to establish a direct connection between these products and the deaths, several complaints had been lodged where the device had failed to activate in a crisis situation.

Despite several instances of the device failing to work, the complaints were deemed as insufficiently frequent to act upon. Previous objections expressed by the FDA were also condoned and several devices containing the “potentially defective component” continue to be shipped.

Expensive devices may lead to a fall in sales revenue

As tens of thousands of the products have been recalled by companies, such as Mylan, that uphold “quality and patient safety” – Pfizer would most likely be facing tremendous pressure during these challenging times in overcoming this sales slump. Increasing competition in the market for these devices would also be driving prices to lower rates in order to attract a greater number of customers. MIMS



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