FDA: EpiPen shortage affects Texas

FDA reports shortage of EpiPens, citing 'manufacturing delays'

FDA reports shortage of EpiPens, citing 'manufacturing delays'

The advocacy group FARE (Food Allergy Research & Education) put the pressure on the FDA, the U.S. Department of Health and Human Services and the Trump administration to take immediate action to address the national shortage of epinephrine in a statement issued May 7.

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.

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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. In some instances, patients were hurt or died as a result of faulty injectors.

In the meantime, Mylan's producer, Pfizer, says they "cannot commit to a specific time for when the supply constraint will be fully resolved".

Meridian also says production has increased over the last few months and that shipping should continue to increase and stabilize.

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Pfizer did not immediately respond to a request for comment. Manufacturers are required to report possible shortages to the regulator. Mylan is expediting shipment to wholesalers upon receipt, and supply levels may vary across wholesalers and pharmacies.

There is a shortage of life-saving EpiPens in America, the FDA has declared. Some parents are concerned about the shortage of the Epipen brand because many summer camps require it. Mylan successfully pushed for United States legislation to encourage the use of EpiPen in schools nationwide.

"Mylan Customer Relations has been able to successfully locate alternative pharmacies for patients who are experiencing difficulty in accessing product", spokeswoman Lauren C. Kashtan said.

Mylan said its net income rose 31 percent to $87.1 million, or 17 cents per share, in the first quarter.

"In the event it becomes an issue for the patients and the backlog from the pharmaceutical company gets bad, there's always the good old fashion pre-drawn pre-filled syringes is that we store for our patients", said Dr. Allen.

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