26.09.2020

FDA blames ‘manufacturing delays’ for short supply of EpiPen

The emergency allergy treatment, produced by Mylan NV, was added to the agency’s list of drugs in short supply on Wednesday, with ‘manufacturing delays’ listed as the cause.

There is a shortage of life-saving EpiPens in America, the FDA has declared. While families can still get hold of the lower-dose version, EpiPen Jr, as well as generic versions, the news sparked panic for the XX Americans who rely on them day to day.

The filing comes amid an identical shortage in Britain, Canada and Australia, where the product has been in short supply since January this year. The situation has become so dire in Australia that families have been driven to exchanging out-of-date EpiPens online.

The FDA said manufacturing delays were creating supply constraints of EpiPens in the US

Mylan, which had declined to comment for nearly a month about possible US EpiPen shortages, on Tuesday said it notified the FDA a few months ago of supply issues due to delays at manufacturing partner Pfizer Inc.

This was Mylan’s first acknowledgment of possible US supply issues following reports of EpiPen shortages in Canada and Britain last month.

Erin Fox, senior director of drug information at University of Utah Health, said the FDA is in a tough spot because it relies on drug companies to provide information about shortages.

‘If the intent of that notification is that the FDA can work on prevention and mitigation strategies before a shortage even happens, the FDA needs to know all the details,’ Fox said.

‘The FDA is not getting that from the pharma companies.’

Mylan said it is receiving ‘continual’ supply from Pfizer unit Meridian Medical Technologies, which produces all EpiPens sold globally at a single plant near St. Louis.

Meridian Medical has been hit by a series of manufacturing problems.

In March 2017, Mylan recalled tens of thousands of devices after complaints that some had failed to activate and in September it received a warning letter from the FDA.

EpiPen autoinjectors deliver a dose of epinephrine in the event of severe allergic reaction, such as to bee stings or exposure to peanuts. Experts say America’s shortage has been a long time coming.

Australia’s shortage stems from supply delays in America, where the pens are exported from.

‘We understand how important this potentially life-saving product is to patients, and are working tirelessly to increase production and expedite shipments as rapidly as possible,’ a spokesman from Pfizer told Daily Mail Australia.

While one doctor told Daily Mail Australia that out-of-date medications may still be safe to use, another warned that some doctors are going rogue.

Maria Said, CEO of Allergy & Anaphylaxis Australia, warned doctors against teaching patients how to draw up adrenaline using a needle, as some have reportedly been doing.

‘This is very dangerous practise for lay people because mistakes can easily be made with drawing up the correct dose,’ she said.

‘This is a challenge for many health professionals that do not use the medication often and are not familiar with correct dosages.’

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