MIAMI -- The FDA issued an alert Tuesday after the manufacturer issued a letter the day before to healthcare providers describing the reasons its EpiPen, EpiPen Jr and authorized generic versions might not work or be delayed working.
"Since EpiPen is administered for severe and potentially life-threatening allergic reactions," the letter from Pfizer and Mylan says, "anything that prevents or delays the administration of the intended dose of epinephrine could result in a high risk to the patient, including the risk of death."
Epinephrine treats severe allergic reactions. People with serious food allergies or allergies to bee stings or the like often carry EpiPens or generic versions.
The letter details four reasons -- two by user error and two by design -- a malfunction might occur:
-- The blue safety release being removed by a "sideways force," causing the EpiPen to activate before it should. Thus, the EpiPen can't inject the epinephrine.
"This can occur if a user tries to hold the EpiPen with only one hand and tries to remove the blue safety release with their thumb using a lateral force," the letter said.
Instead of just using a thumb or pulling and twisting the safety release to work it open, the letter advises, use one hand to hold the EpiPen with the orange end pointing down and the other hand to pull the safety release straight up.
Adults giving an EpiPen to a child are told to restrain the child and use two hands, although it didn't make suggestions on how to restrain while retaining the use of two hands for the EpiPen.
-- "Device failure from inadvertent or spontaneous activation due to a raised blue safety release." Check the EpiPen to make sure the safety release isn't already raised. If it is, the letter said, don't try to use it. Call Mylan at 800-796-9526 for free replacements.
-- The EpiPen doesn't come out of the carrier tube smoothly. Though Pfizer estimates this is a two in a million problem, it can prevent the EpiPen from coming out of the carrier tube and can be in any EpiPen in the United States with an expiration date before September 2020.
"A slight deformation on the open rim of the plastic carrier tube that may be present but may not be visually obvious to patients/caregivers," can keep the EpiPen from quickly being drawn and shot when speed is sacrosanct.
The letter suggests test sliding the EpiPen to make sure it will come out quickly when necessary.
-- Common user errors. Listed in the letter were not taking the EpiPen out of the carrier tube; not removing the blue safety release; using the auto-injector upside down, so the user shoots himself in the hand; not using enough force to apply the EpiPen; shooting it into somewhere other than the outer thigh; and not holding it in place for a full three seconds.
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