WHAT WERE THEY THINKING?
The Food and Drug Administration, or FDA, is charged with approval of new
drugs and to certify the safety and value of drugs to the general public. Recently,
a decision was made by this august body that defies belief. Many years ago a
drug whose brand name was Primatene Mist was on the over-the-counter
market. It was inhaled epinephrine. This product was used by patients with
asthma as an unsupervised treatment. The problem is that this preparation is not
considered a safe treatment for asthma and, because of its short duration of
action and unsupervised use, can lead to serious side effects.
Primatene has been reapproved by the FDA for over-the-counter purchase.
The way in which this was done sets a dangerous precedent. No public input was
requested, as is usually the case, despite longstanding concerns about the safety
of this product. The reasons for safety concerns are long and some complicated
but they include excessive cardiac stimulation and rhythm disturbances, increased
asthma fatalities due to self-medication excess, and improper therapy. These
types of misuse and adverse events from epinephrine inhalers are well
documented and serious.
The approved medical alternative is albuterol, which many patients use
with good effect and safety. The cost of albuterol, which can be purchased as a
generic, is within several dollars of epinephrine and provides many more levels of
safety for the patient. I would encourage anyone to avoid the use of inhaled