News
Manufacturer Pushes to Return Primatene Mist to Shelves
Eileen Oldfield, Associate Editor
Published Online: Tuesday, August 7, 2012
The only OTC asthma inhaler was pulled from the market at the end of 2011 due to environmental concerns, but its manufacturer is trying to bring it back.
Amphastar Pharmaceuticals, the manufacturer of Primatene Mist, has launched a campaign to bring the OTC asthma inhaler back to the market. The inhaler was removed from pharmacy shelves at the end of 2011 due to its use of chlorofluorocarbon (CFC) propellants, which deplete the ozone layer.
The inhaler was removed from the market to comply with the Montreal Protocol on Substances that Deplete the Ozone Layer, an international treaty in which countries pledged to phase out specified substances that deplete the ozone layer by agreed-upon dates. The FDA initiated public discussion on the CFCs in epinephrine inhalers such as Primatene Mist in 2006 and, in November 2008, notified the public that these inhalers would be phased out at the end of 2011.
During these discussions, the FDA also announced the phase out of 7 metered-dose prescription inhalers that used CFCs. Five of these inhalers have already been taken off the market, and the remaining 2—albuterol and ipratropium, and pirbuterol—will be available until December 31, 2013.
Prior to its phase out, Primatene Mist was the only asthma inhaler sold OTC. It was indicated for temporary relief of occasional mild asthma symptoms. After the phase out, patients using Primatene Mist were advised to see a health care provider about switching their asthma medication. (Click here for our article with advice for former users.) Several prescription inhalers that had used CFCs were reformulated to use hydrofluoroalkane (HFA) as a propellant instead, but Primatene Mist was not.
Amphastar contends that an OTC inhaler is a necessity for many patients, particularly those without health insurance. Company representatives announced their campaign to bring Primatene Mist back on July 18, 2012, during a US House of Representatives Energy and Commerce Committee Energy and Power subcommittee hearing on the Asthma Inhalers Relief Act of 2012, which would allow the sale of the 1 million Primatene Mist inhalers the company says it has in storage until they expire in August 2013.
“We are fighting to get Primatene Mist back on the market, and donating all of the net profits to charity, because we believe in our product and want it to be abundantly clear we are doing this for the millions of Americans who used to rely on Primatene Mist and not to make money,” Jason Shandell, vice president and general counsel of Amphastar Pharmaceuticals, said in a press release. “We all strive to protect the environment, but we believe it is essential to have an over-the-counter inhaler available until a replacement without CFCs is available.”
The American Thoracic Society, however, has advised against bringing epinephrine inhalers such as Primatene Mist back to the market because epinephrine is no longer considered a safe medication for treating asthma. According to a statement made by the society’s president, Monica Kraft, MD, to the Energy and Power subcommittee, this view is shared by the American College of Asthma, Allergy and Immunology; the American Association of Respiratory Care; and the National Association for the Medical Direction of Respiratory Care.
In addition, Dr. Kraft noted, in 1999 the American Medical Association argued for stronger warning labels on OTC epinephrine inhalers to alert patients to the dangers they posed and encouraged the FDA to remove the inhalers from the market. According to Dr. Kraft, epinephrine dilates the heart and other organs when treating the lungs, causing increased heart rate. In older patients or patients with heart disease, this can lead to cardiac stress or heart attack.
“If the intent of the legislation is to restore a safe and effective asthma drug to the market place, then this legislative effort is misinformed,” Dr. Kraft said in her statement. “Inhaled epinephrine is not a safe drug for the treatment of asthma. The adverse side effects of epinephrine are serious and well documented. No current clinical practice guideline for the diagnosis and treatment of asthma recommends the use of epinephrine. In fact, asthma guidelines specifically recommend against inhaled epinephrine for treating asthma.”
The American Thoracic Society suggests that patients who have used OTC medications to treat asthma symptoms should see a health care provider and develop an asthma management plan that includes more effective and safer medications.
Previous Pharmacy Times coverage of Primatene Mist:
Amphastar Pharmaceuticals, the manufacturer of Primatene Mist, has launched a campaign to bring the OTC asthma inhaler back to the market. The inhaler was removed from pharmacy shelves at the end of 2011 due to its use of chlorofluorocarbon (CFC) propellants, which deplete the ozone layer.
The inhaler was removed from the market to comply with the Montreal Protocol on Substances that Deplete the Ozone Layer, an international treaty in which countries pledged to phase out specified substances that deplete the ozone layer by agreed-upon dates. The FDA initiated public discussion on the CFCs in epinephrine inhalers such as Primatene Mist in 2006 and, in November 2008, notified the public that these inhalers would be phased out at the end of 2011.
During these discussions, the FDA also announced the phase out of 7 metered-dose prescription inhalers that used CFCs. Five of these inhalers have already been taken off the market, and the remaining 2—albuterol and ipratropium, and pirbuterol—will be available until December 31, 2013.
Prior to its phase out, Primatene Mist was the only asthma inhaler sold OTC. It was indicated for temporary relief of occasional mild asthma symptoms. After the phase out, patients using Primatene Mist were advised to see a health care provider about switching their asthma medication. (Click here for our article with advice for former users.) Several prescription inhalers that had used CFCs were reformulated to use hydrofluoroalkane (HFA) as a propellant instead, but Primatene Mist was not.
Amphastar contends that an OTC inhaler is a necessity for many patients, particularly those without health insurance. Company representatives announced their campaign to bring Primatene Mist back on July 18, 2012, during a US House of Representatives Energy and Commerce Committee Energy and Power subcommittee hearing on the Asthma Inhalers Relief Act of 2012, which would allow the sale of the 1 million Primatene Mist inhalers the company says it has in storage until they expire in August 2013.
“We are fighting to get Primatene Mist back on the market, and donating all of the net profits to charity, because we believe in our product and want it to be abundantly clear we are doing this for the millions of Americans who used to rely on Primatene Mist and not to make money,” Jason Shandell, vice president and general counsel of Amphastar Pharmaceuticals, said in a press release. “We all strive to protect the environment, but we believe it is essential to have an over-the-counter inhaler available until a replacement without CFCs is available.”
The American Thoracic Society, however, has advised against bringing epinephrine inhalers such as Primatene Mist back to the market because epinephrine is no longer considered a safe medication for treating asthma. According to a statement made by the society’s president, Monica Kraft, MD, to the Energy and Power subcommittee, this view is shared by the American College of Asthma, Allergy and Immunology; the American Association of Respiratory Care; and the National Association for the Medical Direction of Respiratory Care.
In addition, Dr. Kraft noted, in 1999 the American Medical Association argued for stronger warning labels on OTC epinephrine inhalers to alert patients to the dangers they posed and encouraged the FDA to remove the inhalers from the market. According to Dr. Kraft, epinephrine dilates the heart and other organs when treating the lungs, causing increased heart rate. In older patients or patients with heart disease, this can lead to cardiac stress or heart attack.
“If the intent of the legislation is to restore a safe and effective asthma drug to the market place, then this legislative effort is misinformed,” Dr. Kraft said in her statement. “Inhaled epinephrine is not a safe drug for the treatment of asthma. The adverse side effects of epinephrine are serious and well documented. No current clinical practice guideline for the diagnosis and treatment of asthma recommends the use of epinephrine. In fact, asthma guidelines specifically recommend against inhaled epinephrine for treating asthma.”
The American Thoracic Society suggests that patients who have used OTC medications to treat asthma symptoms should see a health care provider and develop an asthma management plan that includes more effective and safer medications.
Previous Pharmacy Times coverage of Primatene Mist:
User Comment(s)
Comment(s)
Your comments are valuable to us. Thank you.
Gwen
August 22nd, 2012 - 12:05:00 PM
Thousands are suffering and even dying because they cannot get Primatene mist any longer and the company has a million units sitting in a warehouse? Is this a govt operation or what.
Get off your ass Congress and reverse the law that says primatene mist cannot be manufactured any longer. This medicine which has been around longer than most of you have been alive has saved billions in hospital bills and saved countless lives. Please tell me how a medicine you inhale into your lungs can hurt the ozone. Give me a break. Nobody believes that crap, it's ALL about the drug companies and their lobbyists giving billions to legislators who have the blood of a million asthmatics on their hands.
Get off your ass Congress and reverse the law that says primatene mist cannot be manufactured any longer. This medicine which has been around longer than most of you have been alive has saved billions in hospital bills and saved countless lives. Please tell me how a medicine you inhale into your lungs can hurt the ozone. Give me a break. Nobody believes that crap, it's ALL about the drug companies and their lobbyists giving billions to legislators who have the blood of a million asthmatics on their hands.
Nunnely Brightman
September 6th, 2012 - 10:02:23 PM
I agree with Gwen. The stuff goes into our lungs, not into the atmosphere. This is big drug companies making sure they make all the money. It's disgusting the way our country treats the uninsured. BRING BACK PRIMATENE MIST.
owen ashcraft
September 14th, 2012 - 08:35:44 PM
I have used primatene mist over forty years and if it weren't for it i would be dead. I have experienced no side effects. This is one of the dumbest tricks the government has ever put out.
Jimmie Watson
October 3rd, 2012 - 08:44:33 PM
If it weren't for primatene mist, my buddy and I would not be here today. I just don't understand how we as the greatest nation in the world are willing to sacrifice so many livessake for the sake of making a quick buck. I've been using it for over 25yrs. It's the only thing that works for me, all the others tighten my breathing before opening me up, shame on you guys!
Cheryl
October 18th, 2012 - 01:40:00 AM
I truly believe that this is all due to the power and might of the major pharmaceutical companies. They have the money to lobby congress and get whatever they want, even at the expense of the patients who need the OTC meds. One has to wonder why doctors want the patient to come in for an "Asthma Action Plan"? It is so that the over priced prescription medications can be purchased and the doctors can get repeated office visits, without regard to the patient having health insurance or not. It is becoming an unethical field....
Jeanie
November 27th, 2012 - 12:07:40 AM
I have used Primatene Mist since I was a child for seasonal flare-ups of asthma. I have never experienced one side effect and in many cases it has saved me. I do not have health insurance and I cannot afford an Emergency Room when I wake up and can't breathe properly. I feel that the EPA and FDA are playing politics with my health. I do not want to take an inhaler pumped full of steroids and I feel it is an infringement on my civil rights to suddenly ban a product that has been readily available for so many years. When we get relief from asthma and have our Primatene Mist back? There are many of us in dire need of this OTC rescue inhaler. There are so many pollutants in our environment and I cannot believe that this small inhaler can damage our ozone. It is inhaled and not sprayed into the air. I recently found a Facebook page entitled Bring Back My Primatene Mist and I urge you to please read these comments by many others like me. I never realized how many people benefit from this inhaler until I started researching your recall. Please take 10 minutes and read our posts.
karen
January 17th, 2013 - 08:33:47 PM
I have asthma, and have been using primatene mist for about 15 years. Now that they are considered to be pollutants, I have no way to treat myself for attacks. I work full time, but cannot afford insurance to get a prescription inhaler. Right now, I am forced to purchase prescription inhalers from people who have coverage and prescriptions,which I know is illegal, but the only option I have. the remaining otc options are completely inadequate, and do not work. It is nothing more than corporate greed from the pharmaceutical companies that put the primatenes off the market. since when does corporate interest come before peoples' needs? our government and our elected officials need a major overhaul to get the greed and the money out of it.
John
February 21st, 2013 - 06:58:47 PM
Why did Asthmanefrin replace the Armstrong Pharmaceuticals' Primatene Mist?? The rationale given that the Primatene is an environmental hazard is very precarious, since the Asthmanefrin atomizer requires alkaline batteries and plastic-refills (not to mention the Atomizer itself) which also very harmful to the environment. The Primatene Mist was the only affordable life-line available to uninsured asthmatics. My point being that while Asthmanefrin works ok (when it works), it is cost-prohibitive on an ongoing basis and far too fragile for reliable everyday use over a longer period of time. This means that the atomizer itself will need replacement every so often. I think discontinuation of the Primatene Mist in favor of Asthmanefrin was quite underhanded since it left so many uninsured asthmatics high and dry and with no choice but to shell-out too much money for this questionable product. I say bring back Primatene Mist and let the competition for a fairly priced product begin.
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