This year’sworldwide recallof bad EpiPens has put hoi polloi with severe allergies on alert . And now allergy sufferers have even more reasons to worry . Faulty EpiPens have been cite in the deaths of at least seven Americans so far this year , according to FDA reports that have only been made public this week .
Bloomberg News recently submitted a Freedom of Information Act ( FOIA ) request with the FDA for data about death associated in any agency with thedefective EpiPens . The cases at the FDA are ego - report by patients and doctors , which entail that it ’s a conservative estimate that credibly under - counts the job .
Bloomberg hold data point of EpiPen loser generally ( with and without deaths ) , and the trendisn’t good . While there were just four failures of EpiPens reported in 2012 , those numbers jumped to 12 nonstarter in 2013 and 67 failure in 2014 . As of mid - September , the FDA has receive a whopping 228 reports of EpiPens failing to work as intended in 2017 . Of the 228 EpiPen failures so far this year , thirty - five mass were hospitalized and seven people choke .
Mylan , the God Almighty of the EpiPen , would prefer not to take any substantial part of the blame . The notoriouslyconfrontational drug companyhas enjoin that it ’s “ convinced in the quality , refuge and efficacy of EpiPens ” but seemed to have a tough - shit position about the news that people are dying while trying to use the product .
https://gizmodo.com/drug-company-chairman-to-america-go-fuck-yourself-1795816263
“ One need to keep in judgment that an anaphylaxis event can be deadly and , sadly , even an appropriately allot battery-acid of epinephrine from a fully functional gimmick may not prevent a affected role from go , ” Mylan secernate Bloomberg News in a command . “ We have not identified any causal connection between any reported patient role deaths and Mylan ’s epinephrine car injector products . ”
Yeah , that sound like the Mylan we all know and loathe .
The problem with the FDA reports obtain by Bloomberg is that they do n’t specify exactly how the EpiPens failed , nor do they directly say that the failure of the EpiPens to work was the verbatim causal agency of expiry . Strangely , this leaves consumers without any info about what they can do to protect themselves .
Did the people who die use the EpiPen incorrectly ? Is there anything that consumers can do to verify that their EpiPens work when they ’re needed most ? Gizmodo has reached out to both the FDA and Mylan for comment and will update this station if we hear back .
Mylan has had one outrage after another over the past few years . First , the company jacked up the cost of the product from $ 57 in 2007 to roughly$600 in 2016and had to show in front of Congress about why the company was take part in price gouging . Then the CEO lied to Congress about how much net income the ship’s company wasmaking on each EpiPen . Then the troupe was exposed for over - charging the governmentby $ 1.27 billion . Then Mylan had to issue a general recall for the EpiPen in March because the product wasn’tworking as intended .
And Mylan ’s response to consumers and the regime about its price gouging has quite literally beengo fuck yourself . America ’s regulative agencies are clearly broken and drug companies like Mylan can do whatever the blaze they desire and only get slapped with a fine here or there .
I wish I had good advice for people with serious allergies who are worried about whether their EpiPen will operate , but both the FDA and the drug ship’s company seem to have just three Word for you : Good fate , patsy .
[ Bloomberg ]
Update 10:05am : The FDA just get back to me and it ’s not precisely encouraging :
The FDA recommends you meet the company instantly for that information or submit a Freedom of Information Act request . The FDA track adverse result reports , medicament wrongdoing reports and product quality complaints resulting in untoward events that are submitted to the FDA in a database called the FDA Adverse Event account System ( FAERS ) . However , reportage of untoward events by wellness aid professionals and consumers is voluntary in the United States ( learn more about FAERS reportinghere ) . As such , there are restriction associated with the FAERS datum , and these limitations are listed on the disclaimer varlet of the database , as well as here : https://www.fda.gov / Drugs / GuidanceComplianceRegulatoryInformation / Surveillance / AdverseDrugEffects / default.htm
So , yeah , good of luck .
Update 11:24am : Here ’s Mylan ’s statement , which curiously acknowledge that the company has made no modification to its product since 2009 . Funny how they thought jack up up the price was excuse if that was the case .
Mylan closely follows all report of adverse events concern to our epinephrine car - injector products . All adverse event write up received are investigated by Pfizer and Mylan and report to FDA . We have not describe any causal connection between report patient deaths and gadget loser concern to Mylan ’s epinephrine machine - injector products .
Further , given the increase attention to these mathematical product due to Pfizer ’s voluntary recall in March ( as also comment on by the FDA in the Bloomberg clause ) and an growth in prescription , the cost increase in study received is not unexpected , and such upgrade do not necessarily mean more merchandise unsuccessful person are hap . to boot , it ’s important to observe that no change have been made to the EpiPen equipment since 2009 , ensuring patients have had a consistent user experience since that time . Mylan and Pfizer take each adverse event report seriously and in full review and psychoanalyse all reported events .
We are interested that misleading publicity on this issue could unnecessarily discourage patient role from gestate appropriate discussion for a potentially life - threatening response . uniform with the FDA ’s steering , we encourage patient role to carry and employ their prescribed epinephrine auto - injector . Epinephrine is the first - line treatment for a life - peril allergic reaction ( anaphylaxis ) and access to this product is vital in the case of an hand brake . Since 2014 , we are aware of at least 2,000 incident in schools where an EpiPen equipment , donated by Mylan as part of our EpiPen4Schools program , was administered , potentially saving a kid ’s sprightliness . These represent only a subset of the potential lives impacted thanks to this product .
Patient rubber is Mylan ’s primary concern , and we are confident in the tone , base hit and efficacy of our EpiPen ® products .
Deaths
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