FDA: EpiPen Ads are False and Misleading

The television ad shows an excited child getting ready for Max’s birthday party. But there’s a problem. Jake is allergic to peanuts and who knows what’s in the birthday cake. No worries, the mother says…..“We’re prepared right, Jake? …With EpiPen.”

The EpiPen Auto-Injector, made by Pfizer, contains a dose of epinephrine delivered immediately during an allergic reaction from peanuts, a bug bite or drug reaction. Epinephrine is a treatment for anaphylaxis which causes a flood of chemicals to respond to the allergen and can lead to the potentially life-threatening anaphylactic shock. Administering epinephrine quickly is the key to reversing the reaction.

This is an older model of an autoinjecting EpiPen.

The U.S. Food and Drug Administration (FDA) says the broadcast ad is “false and misleading” because it overpromises the product to the public. Little Jake, it’s suggested, can take a bite of birthday cake and not worry about any potential allergens. The impression is that one need only come armed with an EpiPen, while other precautions, such as avoiding the allergen in the first place, need not be taken.

That promise is in violation of the Federal Food, Drug and Cosmetic Act.

According to the FDA immediate medical care should be sought after use of an EpiPen. In fairness, the ad does encourage a trip to the emergency room for additional treatment.

The FDA also says caution should be used in administering the EpiPen to patients who have artery or heart disease including cardiac arrhythmia, in patients with diabetes, hypertension, the elderly, pregnant women or young children.

An adverse reaction from an EpiPen could include weakness and dizziness, nausea and vomiting, respiratory difficulties and headache as well as restlessness and arrhythmias.

Pfizer, and marketer Mylan Specialty, agreed in November to pay $625,000 to Massachusetts as a settlement to the exaggerated claims of EpiPen. That after the ad ran continuously, 170 times in one week in April 2012, reports the Boston Business Journal, before it was taken off the air. The money will fund consumer protection initiatives.

In a related story, President Obama has just approved funding incentives for schools to stock epinephrine treatments to be used, even on children who do not have a prescription for the drug. It is not unusual for an allergic reaction to appear suddenly even to a substance that the child has already been exposed to. For example, peanut allergies have more than tripled over the last decade for some unknown reason, reports NBC.

With only 27 states allowing schools to administer epinephrine such as EpiPen, the thought is that many lives will be saved with a federal mandate that allows schools to administer the drug in an emergency.