By Henry Ehrlich
Over the weekend a Tweet popped up from @BklynAllergyMom and was forwarded to me by @AmazingAtopic about a commercial for a new product called Asthmanefrin™, touting it as an alternative to Primatene Mist™, which is now off the market. BAM asks, “didn’t we already fight that battle?”
Good question. The key here is that Asthmanefrin™ is delivered via portable atomizer, not chlorofluorocarbon (CFC) aerosol propellant, the way Primatene was. You may recall that the long-time medical consensus was that the over-the-counter epinephrine was bad for asthmatics because it delivered a jolt both to the heart and the lungs, and that, moreover, it provided short-term relief without treating damaging underlying inflammation, increasing the risk of exacerbation. But it was the environmental damage from CFCs that finally spelt its doom, decades after the clock started ticking during the Reagan administration. Even then, the manufacturer, Armstrong, mounted a last-ditch effort in Congress to keep the stuff on the shelves long enough to unload leftover inventory.
I called Nephron Pharmaceuticals to find out something about the new stuff (which turns out to be old stuff—more than 100 years) and reached a very polite and knowledgeable spokesman. First of all, Nephron specializes in manufacturing generic respiratory drugs, including albuterol and racepinephrine, the bronchodilator in Asthmanefrin™, which is widely sold to emergency rooms and is the drug of choice for treating croup as well as asthma emergencies. It has been sold over-the-counter for home nebulizers for many years. Apparently Nephron has 85% of the nebulized albuterol market.
The real innovation here is the ability to deliver fine-particle medication without being hooked up to a machine. That was a big part of Primatene’s appeal—inhaling the mist—instead of having foul-tasting dust stick to the mouth or the back of the throat. The EZBreathe Atomizer, which is powered by two double-A batteries, uses a vibrating mesh to aerosolize the active ingredients so they can be more readily inhaled than large-particle rescue albuterol.
I am not competent to comment on the health effects of this new product. However, I will say this about the politics. I mentioned the eleventh-hour politicking by Armstrong to the Nephron spokesman. He said that Nephron didn’t participate in person at the Congressional hearings that were convened because asthmatics had no over-the-counter relief at hand and would be at the mercy of prescribing physicians or, in the event of an emergency, an emergency room. However, a Florida representative read a letter from Nephon’s CEO informing the committee that Asthmanefrin™ was on its way, letting the air out of Primatene’s argument. It remains off the market.
{Note–Dr. Paul Ehrlich will discuss the medical aspects of this product in a later post.}
Thank you very much for looking into this product! I look forward to Dr. Paul Ehrlich’s commentary on it.
When I was a pediatric resident, we were always taught that any child receiving nebulized racemic epinephrine for croup should be monitored in the healthcare setting for ~4 hours after a dose, because rebound stridor was so common. This product is a wolf in sheep’s clothing.
Regarding the previous comment, there has never been any clinical evidence documented to support rebound stridor, or the so-called “rebound-effect”. Further, there are blogs that exist where respiratory therapists dispel these old fashioned myths.
Racepinephrine is an OTC asthma medication that has been in existence since the late 1800’s. Because Racepinephrine was proven to be safe and effective, the FDA grandfathered approval of this drug when the Agency was formed in the 1930’s. Racepinephrine has a corresponding OTC monogragh, which can be found in the US Code of Federal Regulations 21 part 341.
The duration of action of nebulized racemic epinephrine is known to ~2 hours. Although the medication will not cause an increase in baseline airway edema, a patient’s symptoms may recur once the effectiveness of the initial dose has worn off. This is why clinical guidelines call for 2-4 hour observation periods prior to discharge from the emergency department. If symptoms recur in a monitored healthcare setting, more aggressive management is pursued, including steroids and oxygenation. In the home setting, the likely outcome is redosing, rather than stepped up management. This is especially true in the underinsured or uninsured, who are at increased risk of overusing short-acting medication instead of obtaining the appropriate anti-inflammatory management. Overdosing is the issue with OTC epinephrine for respiratory conditions. This is why we didn’t like Primatene mist. No medical professional was ever wound up about the negligible effect of inhaler CFC’s on the ozone layer. Furthermore, being grandfathered in by the FDA in the 1930’s doesn’t make a drug safe for unsupervised use at home, especially in the absence of appropriate medical guidance. Just look at acetaminophen – if it needed to go through the aaproval process all over again, it would never achieve OTC status.