Posted on 04/07/2007 7:00:59 PM PDT by dangerfield
Jan. 24, 2006 — A U.S. Food and Drug Administration committee voted 11-7 today to recommend that certain over-the-counter asthma inhalers, such as Primatene Mist, be taken off the market over concerns that they contain chlorofluorocarbons that could harm the environment.
Chlorofluorocarbons have been associated with depleting Earth's ozone layer, which can in turn contribute to global warming and skin cancer. But another issue at hand, according to health experts, is that Primatene Mist may do patients more harm than good.
The recommendation now means that the FDA will vote whether to keep over-the-counter inhalers on the market, said FDA spokesperson Laura Alvey.
Primatene's manufacturer, Wyeth, issued a statement saying the company was "disappointed."
"The recommendation was clearly not in the best interests of patients who rely on an [over-the-counter] rescue option for acute asthma attacks," the statement said.
But critics say that Primatene Mist is not an effective asthma treatment.
The active ingredient in Primatene Mist is epinephrine, commonly known as adrenaline. Although this ingredient opens the airways of asthma patients, it can also have potentially serious side effects on the heart and blood vessels.
These side effects, in turn, can lead to increased blood pressure and palpitations, doctors say.
"I would argue that based solely on the [lack of] efficacy and harm of over-the-counter asthma inhalers to patients, that these products should be withdrawn from the market regardless of their contribution to the CFCs in the environment," said Dr. Ronald Ferdman at the Children's Hospital in Los Angeles.
According to Wyeth, 2 million people use the product in combination with other inhalers, and another 1 million use it alone. It generated about $43 million in sales last year.
Instead of Primatene Mist, physicians most often use a drug called albuterol to provide quick-acting relief to patients who suffer the symptoms of asthma. Doctors say that albuterol is much safer than Primatene Mist because it is longer-acting and has fewer side effects.
Asthma-management guidelines published in 2002 by the National Heart, Lung and Blood Institute did not include any over-the-counter inhalers. These guidelines help doctors make treatment choices.
However, pulling these products from the market could force patients who self-treat their asthma to obtain proper care from physicians, said Dr. John Murray of Vanderbilt University Medical Center.
"The real concern is letting people self-medicate their asthma and potentially get into serious trouble covering up the symptoms," Murray said. "If [Primatene Mist is] pulled from the market, the result would hopefully bring more asthmatics to seek appropriate medical care."
Dr. Clifford Basset, medical director at the Allergy and Asthma Care of New York, agrees these drugs can increase the risk of harm to patients.
"Over-the-counter asthma inhalers will delay proper … treatment for asthma, which can be associated with fatalities," said Basset.
Unlike the common cold, asthma is a disease that needs specialized care, Ferdman said.
"Some diseases can be treated without the help of a doctor," he said. Asthma is not one of these."
Dr. Mark Wernick is with Beth Israel Deaconess Medical Center in Boston.
Does anyone know what the current status is regarding over the counter inhalers? Have they indeed been taken off the market? Thanks.
Do you realize what a tiny amount of propellant is needed for a little (lifesaving in some cases) inhaler?
A lot of cold and allergy medicines apparently have ingredients that go into the "meth" recipe and that has caused them to move to behind the counter.
If you're an asthmatic, be forewarned.
I'd bet none do.
Is this true? I hope not. I use primatene mist. I don’t have a major asthma problem, but sometimes, like once in a blue moon I need it because of allergies. The prescription inhaler doesn’t even work for me. With primatene I take one puff and it fixes the problem instantly.
They’re gonna try it with incandescent bulbs, cars, boats, houses, AC, re-fridge-e-dators.....until we all live in trees.....Then they can let the Muslims take over. Easy job so far.
So, people suffer, on the off chance that the medication they need “may” and a say again “may” cause damage our ecosystem.
There are other excellent reasons to take inhalers like Primatene off the market. I have family members who are asthmatic, and I’ve told them not to touch the stuff. I’ve seen patients get into real trouble with Primatene who would have done fine with Albuterol.
The problem with the epinephrine inhalers is that the effects don’t last long, and sometimes people get a rebound effect - when it wears off, they’re much worse than they were before using. Albuterol is far safer. Primatene would never get FDA approval today.
I have no answer to contribute to your dilemma, however as
“Capt Norm” has commented “Meth” may be the real reason for this situation.
Recently here at FR, I think in Fridays posts was an article about Baking Soda being removed to regulated sale due to it being used as a base for “Meth”.
Seems as though our “leaders” are taking the easy way out opposed to confronting the problem in our society.
Their alert is here
That's why I'm asking how many asthmatics there were on the committee ~ the next question is "why"?
On the face of it the FDA committee's recommendations seem to have been fraudulently developed and proposed.
I have no idea what went into it, but if the committee members were asthmatics and medical professionals, they might see it as a way to protect other asthmatics against a bad drug. There’s a reason that doctors, asthmatic or not, don’t recommend the stuff. Asthmatics on the committee wouldn’t change that.
I also know that albuterol and other changed their propellant system to comply with regulations. I wonder why Primatine couldn’t do the same.
It’s already happened with prescription inhalers, specifically albuterol. Now we are subjected to an inhaler, that for me, doesn’t work as well as the old inhaler; same medicine, inferior delivery system. The two pharmacies that we use tell me that most of their customers who receive the new inhaler say the same thing.
Plus, again my personal experience, the price has doubled. So, screw your health for the advancement of socialist policy. But, that’s pretty much redundant.
Primatene is just a bad drug. Don’t use it. There are prescription medications that will do a much better job on your asthma without the cardiac side-effects. As you get older, these side effects can have serious consequences. Primatene isn’t being taken off the market because of some massive conspiracy to send you to an expensive specialist but because patients can get into a bad situation with them.
Some people believe that albuterol is not as effective as drugs like Primatene, but that’s partly because the albuterol takes longer to work. Yet it lasts longer, too. And while it may not be as effective for you, the steroid inhalers like beclomethasone may keep you from needing any bronchodilator inhaler at all.
Asthma can be fatal. If any disease merits consultation with a physician, this does. Please go see an allergist or pulmonologist.
We just got a letter from Cigna about this concerning my daughter’s inhaler—said that pretty soon (before the end of April!) they were discontinuing these, and we would have to get the more expensive brand name inhaler PLUS before we could do that we’d have to get a brand new prescription. I’m calling her ped on Monday to see what the story is, but if this isn’t an example of ‘nannyglobalwarmingism’ I don’t know what is!
Unfortunately, I think medicine policy people focus overly much on an 80/20 rule, and forget all the edge cases who have reactions to medications, or just need a slightly different treatment approach.
I've got a buddy with asthma, and I'm always on his case to have a backup inhaler handy in case he runs out or breaks his primary.
You can argue the merits of Primatene all day long ~ good or bad ~ but the committee is reported to have sidestepped such a difficult task.
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