Primatene® Mist is an over-the-counter (OTC) inhaler for asthma patients that has been used safely by millions of people for more than 46 years to help them cope with asthma related symptoms including shortness of breath. It is manufactured by Armstrong Pharmaceuticals, Inc. which is a wholly-owned subsidiary of Amphastar Pharmaceuticals, Inc. There is currently no OTC inhaler for asthma patients available.
If someone without a prescription for an inhaler is suffering from asthma symptoms, they either need to go to the emergency room — which can cost thousands of dollars — or simply endure the pain and shortness of breath.
The existing supply of Primatene® Mist inhalers (approximately 1 million units) expire in 2013, and the EPA has not granted permission for additional CFCs to be used to create additional inhalers. If the EPA allows the current supply back on the market, it would only be until August 2013.
Amphastar/ Armstrong has received thousands of complaints and inquiries from people who used, benefited from and want continued access to the product.
Amphastar has repeatedly asked for guidance from the EPA, and received no response, about how to dispose of the current supply of Primatene® Mist inhalers without releasing the CFCs into atmosphere. It is better to allow the approximately 1 million currently available units be made available to help people suffering from asthma, rather than to waste them and still have the CFCs escape into the environment.
There are prescription inhalers still on the market which contain CFCs and they are being used by asthma sufferers. It is difficult to understand why some prescription inhalers containing CFCs are still allowed to be sold, whereas Primatene® Mist, which was the only OTC inhaler, has been banned.