After more than 50 years on the market, Primatene® Mist, the only nonprescription bronchodilator inhaler, will no longer be manufactured, sold or distributed in the United States as of Dec. 31, 2011. Why not? Because Primatene Mist, which is inhaled epinephrine, contains chlorofluorcarbon (CFC) propellants.
CFC propellants deplete the stratospheric ozone, the layer of Earth’s atmosphere that filters out harmful UV radiation from the sun. It’s a problem caused largely by industrialized countries that could not be solved without worldwide support and cooperation. All UN-recognized nations ratified a treaty, the Montreal Protocol, which calls for an end to use of CFCs and other ozone-depleting substances, and over the last 25 years these nations have phased out production of CFCs and used up any remaining supplies of them. Most asthma inhalers containing CFC propellants have been replaced with ones that use hydrofluoroalkane (HFA) propellants, which do not affect the ozone layer, or even propellant-free devices.
Could Primatene Mist be manufactured without CFCs? “There are no technical barriers to making a non-ozone depleting epinephrine,” says Badrul Chowdhury, MD, director of the U.S. Food and Drug Administration’s (FDA) Division of Pulmonary, Allergy and Rheumatology Products. Many inhaler manufacturers have developed products using allowable propellants, and FDA has now even approved one called Combivent® Respimat® — ipratropium bromide and albuterol for treatment of chronic obstructive pulmonary disease — that uses no propellants at all.
Chowdhury says that in 2008, Primatene Mist’s manufacturer, Armstrong Pharmaceuticals, asked FDA for a three-year extension to allow the CFC-containing product to stay on the market. Primatene Mist was scheduled to go off the market in that year. Armstrong said it would use the extra time to bring an alternative inhaler product with HFA propellants through the approval process and ready supplies for the consumer market.
Termination Schedule of Essential Use Exemption for CFC Bronchodilator Inhalers
|Dec. 31, 2008|
|Dec. 31, 2011|
|MaxAir||Dec. 31, 2013|
|Combivent|| Dec. 31, 2013
In September 2011, Armstrong again stated it has an HFA epinephrine product in development but offered no date for submission to FDA for approval. Company representatives declined to answer exactly how many Primatene Mist canisters are sold or used and said they do not know patient profiles of typical customers.
Is there a therapeutic benefit of Primatene Mist over alternatives available today? Inhaled epinephrine was the first class of bronchodilator to be manufactured, and newer drugs that focus more specifically on the airways in the lungs have appeared over the last several decades. “Fifty years ago, Primatene Mist was the drug of choice because others did not exist. But today we have better choices,” Chowdhury explains. “We know that asthma is not a ‘one drug for one disease’ type of condition; there is no benefit of Primatene Mist over existing options.”
What do the National Asthma Guidelines from the National Institutes of Health (NIH) say about inhaled epinephrine? The guidelines recommend against using it, and GINA (Global Initiative for Asthma) guidelines do not list inhaled epinephrine as a drug of choice. There is also a lack of support for inhaled epinephrine’s use for asthma under any circumstances among medical professionals and nonprofit patient advocacy organizations.
Even so, “this situation is not going to sit well with some people who use Primatene Mist,” contends Allergy & Asthma Network Mothers of Asthmatics (AANMA) President Nancy Sander. There are no government vouchers or support to help offset the cost of physician visits or replacement prescription medications for those now using Primatene Mist, she says.
Over the last 26 years, AANMA has tried to gather information on who exactly is using Primatene Mist, while stressing that better, longer-lasting relief of their asthma symptoms is possible by seeing a qualified physician and using more effective medications available today. From numerous surveys conducted, AANMA has found that few if any of its members use Primatene Mist. “They understand asthma can kill and that it’s not an over-the-counter [OTC] disease,” Sander explains, and that treatment for the disease should be individualized for each patient.
Most people who use Primatene Mist do so out of convenience rather than financial need, according to AANMA’s research. Most have medical insurance and use prescription medications for asthma and other conditions. Some report having purchased and used Primatene Mist when they forgot to carry their prescribed inhalers; others dislike going to the doctor for diagnosis or treatment in general and prefer non-prescription OTC remedies.
Organizations and pharmaceutical manufacturers are working to ensure as smooth as possible a transition for Primatene Mist when the product is discontinued. For example, Teva Respiratory, maker of several HFA-containing inhalers, has developed materials on Primatene Mist’s market removal and is sharing these materials with pharmacists nationwide to help mitigate potential problems. Teva also announced it is also making free samples of its inhaler products available and is offering financial assistance for them to help out those who’ll face new costs once Primatene goes off the market.
Reviewed by Cathy Boutin and Neil MacIntyre, MD
FDA informational flier:
Help Paying for Inhalers
Partnership for Prescription Assistance – 888-477-2669 or www.pparx.org
Rx Hope – www.rxhope.com
NeedyMeds – www.needymeds.com
Boehringer Ingelheim Cares Foundation Patient Assistance Program
800-556-8317 – http://us.boehringer-ingelheim.com/about-us/philanthropy/patient-assist.html
GlaxoSmithKline Bridges to Access 866-728-4368 – www.bridgestoaccess
Teva Specialty Pharmacy Patient Assistance Program 866-482-9633
AstraZeneca Patient Assistance Program – 1-800-424-3727 or www.azandme.com
Pfizer Connection to Care – 866-776-3700 or 866-706-2400 or www.pfizerhelpfulanswers.com
Merck Helps – 800-727-5400 or www.MerckHelps.com