Why No OTC Asthma Inhalers?

So, they say asthma medicines save lives. They say side effects are negligible. So, why do I need a prescription to get one? Why aren’t asthma inhalers available over the counter (OTC)? These are great questions and I have good answers. Allow me to explain.

History of OTC asthma inhalers

To get our answers we have to travel back to 1956. This was a great year for asthmatics. That was the year the inhaler was invented. The first inhaler medicine was epinephrine. The second was isoproterenol. A year later, in 1957, they entered the market. These were the first two asthma rescue inhalers. They were called the Medihaler Epi and Medihaler Iso.1

As you can imagine, this was a huge boon for asthmatics. This was not the first time asthmatics had access to rescue medicine. However, it was the first time it was available in small, portable devices.1 They could be stuffed in pockets and purses. They could be used anywhere, anyplace, and anytime. It was such an awesome invention.

But, there was a surge in asthma-related deaths. Doctors were made aware of these statistics. This resulted in a subsequent decline in rescue inhaler prescriptions.1

Theories explaining the surge in OTC asthma inhaler-related deaths

There were various studies attempting to explain this. No conclusive answers were discovered-- there were only theories postulated.

One theory blamed the inhalers. Epinephrine opens airways to make breathing easier. But, it also has a strong cardiac effect. So, the theory said side effects of these inhalers were too strong for some asthmatics. This caused their deaths.1

Another theory blamed the deaths on poor education. This is the theory I like best. It postulated that asthmatics were over-relying on their inhalers. They were using them too much. They puffed and puffed and puffed. They figured they could treat their asthma attacks on their own, rather than seeking help. By the time they finally sought help it was too late.1

The spark of a major educational campaign

So, this inspired a major educational campaign. Doctors were educated about these inhalers. Doctors were taught to educate patients, rather than deny them inhalers that could save their lives.1

Patients were instructed to only use them as instructed. If they used them more than prescribed, they were to seek help. In this way, an increase in inhaler use was seen as a sign of poor asthma control.1

This seemed to help quite a bit. These inhalers were soon available over the counter (OTC). Surely this was a good idea. It made the inhalers easier to get and made them cheaper.1

The epinephrine inhaler stayed on the market until 2011. It stayed on the market not because it was considered safe, but because it was grandfathered in. By this time, however, it was a generic inhaler and was called Primatene Mist.2

Now, let’s put the epinephrine inhaler aside.

Finding a safer alternative to epinephrine inhalers

Researchers continued working with the epinephrine molecule. In the 1970s they came up with a stronger rescue medicine called metaproterenol (Alupent). It still had some cardiac effects, but, it was much safer than the old epinephrine inhalers. During the 1970s and 1980s, Alupent was the most prescribed asthma rescue medicine.3,4

In 1984, Alupent was considered very safe. So, it was introduced as an OTC medicine. Again, it was decided this would make the medicine easier to get. It would make it cheaper. I know, because I loved this. I needed one and didn’t have to tell mom and I didn’t need to see my doctor. I just walked into a pharmacy and bought one with cash.

But, again, there was a surge in asthma-related deaths.4 I read the stories in the evening newspaper. If I remember right, there were seven deaths blamed on the inhalers in a short period of time. The same two theories mentioned above were discussed again.

Easy and cheap meds are not always the best solution

Rather than mess around, the FDA quickly decided to make Alupent a prescription medicine again. It was no longer available OTC.

This was a little frustrating for asthmatics like me. But, in retrospect, I think they made a smart decision. Yes, it’s nice to have easy access to rescue medicine. Yes, it makes them cheaper. But, as the history of OTC asthma inhalers shows, what’s easiest and cheapest is not always what’s best for asthmatics.

And now you know why.

Editor's Note: In November 2018, the FDA approved over the counter Primatene Mist for the treatment of mild asthma.

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