Asthma sufferers get the shaft: FDA bans CFCs in some inhalers from next year

[caddis]

Just another example of how government regulations will drive up the cost of products and endanger the lives of humans. Now you will need to go to a doctor and get a prescription and pay much more for a medicine that should be readily available to anyone that needs it:



(Reuters) - Health officials are banning the only asthma inhaler sold over the counter in the United States starting from next year to prevent the use of products that harm the environment.

The Food and Drug Administration said on Thursday that chlorofluorocarbons (CFCs) in metered-dose asthma inhalers that contain the drug epinephrine cannot be used, following an international agreement that bans CFCs because they deplete the Earth's ozone layer.


Right now, the only such inhaler is marketed by Armstrong Pharmaceuticals, a unit of Amphastar. The company could not be immediately reached for comment.

The inhaler, called Primatene Mist, is used for temporary relief of occasional symptoms of mild asthma, and is the only FDA-approved inhaler sold over the counter without a prescription, the FDA said.

The product uses CFCs to propel medicine out of the inhaler so patients can breathe it into their lungs. The FDA said some manufacturers now use a propellant called hydrofluoroalkane instead, which is less harmful to the environment.

The FDA first proposed phasing out the use of CFCs in asthma inhalers with epinephrine in 2006, and finalized the phase-out in November 2008.

Primatene Mist inhalers are already labeled to show they cannot be used after December 31, 2010. The FDA said some consumers may have to pay more for prescription asthma inhalers.

About 1 million to 2 million patients use Primatene Mist, although it is difficult to get an estimate of how many people use over-the-counter drugs, the FDA said.

More than 235 million people worldwide suffer from asthma and it is the most common chronic disease among children, according to the World Health Organization.

Really? Asthma suffers are burning a hole in the ozone?

Maybe our resident nurse can come in here an explain to us just who could use an epi-enhaler because in an emergengy it could save a life

[86Dùde]

Once the asthma sufferers don't have their medication then only the asthma sufferers will be criminals. I see DEA SWAT raids in their future.

[caddis]

I see people will have to get their supply from below the border when they are purchasing their light bulbs

[Lulu]

Hello. The CFC thing has been in the works for at least 5 years. And people have died from Primatine Mist - that is not appropriate treatment. Sorry, but anyone with asthma needs to be treated by a doctor, they do not need to self medicate w/ over the counter drugs. Those are the ones who end up dead or in the ER. The pharma companies all have different delivery systems now so never fear, problem diverted. :)

The CFC thing has been a huge pain in the ass. But in reality it's simply cost pharma companies more because they had to come up with new delivery systems for the same meds.

[86Dùde]

Uh huh. We don't need protection from UV light. Just give the sufferers a brown paper bag and moral support. Maybe Michelle Antoinette can send some cake to the poor folks too!

[caddis]

Hello. The CFC thing has been in the works for at least 5 years. And people have died from Primatine Mist - that is not appropriate treatment. Sorry, but anyone with asthma needs to be treated by a doctor, they do not need to self medicate w/ over the counter drugs. Those are the ones who end up dead or in the ER. The pharma companies all have different delivery systems now so never fear, problem diverted. :)

The CFC thing has been a huge pain in the ass. But in reality it's simply cost pharma companies more because they had to come up with new delivery systems for the same meds.

No, people have died from asthma. If they died because they didn't use a prescribed medicine then that is the fault of our government which refuses to place albuterol on the OTC list.

And epinephrine is not simply used for asthma it should be in everyone's emergency kit for severe allergic reactions. Regardless, the law is foolish, CFC's from inhalers do not make a dent on the ozone but removing them has increased the cost to the millions that suffer from asthma

[86Dùde]

It really sucked when clintoon and friends banned R-12. Nobody could get high off freon anymore.

[Lulu]

No, people have died from asthma. If they died because they didn't use a prescribed medicine then that is the fault of our government which refuses to place albuterol on the OTC list.

And epinephrine is not simply used for asthma it should be in everyone's emergency kit for severe allergic reactions. Regardless, the law is foolish, CFC's from inhalers do not make a dent on the ozone but removing them has increased the cost to the millions that suffer from asthma
People have died from Primatene Mist because it does nothing to help with the cause of asthma and it can cause heart problems. They can and do abuse Primatene - also epinephrine is NOT appropriate for chronic asthma. Albuterol is not put on the OTC for very good reason... again, people overuse and abuse it, block their receptor sites in their lungs and nebulized cocktails can't always help them at that point. Doctors need to monitor how much someone is using their albuterol, because if they are using too much, they need other meds.

I already said the CFC law is dumb. In fact, it has kept albuterol fairly expensive because generic companies would have had to develop a new delivery system (which costs them research money so they don't do it).

[86Dùde]

People die from bee stings. People die.

[Lulu]

People die from bee stings. People die.

WTF is your point? I'm explaining why Primatene sucks and why albuterol is not OTC.

[caddis]

People have died from Primatene Mist because it does nothing to help with the cause of asthma and it can cause heart problems. They can and do abuse Primatene - also epinephrine is NOT appropriate for chronic asthma.
Couldn’t something similar be said about any over the counter medication? Nasal sprays? Allergy medications? Aspirin?


Albuterol is not put on the OTC for very good reason... again, people overuse and abuse it, block their receptor sites in their lungs and nebulized cocktails can't always help them at that point. Doctors need to monitor how much someone is using their albuterol, because if they are using too much, they need other meds. Not that I am disagreeing with you with respect to monitoring the use of ANY medication but I’m looking at it from a risk/reward/cost standpoint.

Asthma numbers worldwide are ginourmous and in America they are no better:

Each day:

• 40,000 people miss school or work due to asthma.
• 30,000 people have an asthma attack.
• 5,000 people visit the emergency room due to asthma.
• 1,000 people are admitted to the hospital due to asthma.
• 11 people die from asthma.

11 people die each day....Primatene Mist can’t compare

If you are unwilling to release Albuterol or a number of allergy medications because of your fear of misuse than maybe the system should be improved. I see it as a large number of people are suffering because of government regulation and a nanny attitude and those not suffering (getting proper meds) are paying high dollar

My car must get monitored (smogged) by the state more often than my doctor monitors my medication. I suspect the circumstances degrade as income/insurance levels decrease. What is wrong with issuing chronic asthma or allergy sufferers a card that allows them to purchase meds directly from a pharmacist without having to visit a doctor for a prescription? Or better yet, enter their name in a data base so all pharmacists can monitor their usage....(I’ve had better discussions with pharmacists concerning medications than I have with doctors)

[86Dùde]

WTF is your point? I'm explaining why Primatene sucks and why albuterol is not OTC.

Now don't go being like dat.

[Lulu]

Now don't go being like dat.

Heh, I was working on this google document and the formatting was making me crazy. Made me a little snappy.

caddis, I'm in pharmaceuticals and I've sold in the respiratory market - you wouldn't believe the stories doctors have told me. Patients who keep the cap on because they don't like the taste of the medicine; people who spray the inhaler on their chest like it's vick's vapor rub. People are not always the brightest bulbs on the porch. Also, OTC does not necessarily mean cheaper. It only gets cheaper when it goes generic...that's what I was saying about the CFC issue... generic companies would have come up w/ new delivery systems to sell albuterol (which is already off patent) and they aren't going to do this. Go check out the price of brand name Claritin if you don't believe me on the cost thing. And really if you subscribe that most meds should be OTC, why not sell blood pressure or statins over the counter.

I've never said asthma doesn't kill people. It does and that's why they need to be monitored by physicians rather than self treating. People aren't going to die of seasonal allergies, they can die because of asthma.

Most people can simply get refills by calling their doctor, but the doctor will also see if they are going through inhalers more than they should. And if the person has insurance, inhalers are about $20-30/month. They wouldn't be any cheaper OTC.

And btw Bush is the one who signed this into law.

[86Dùde]

Folks, I think LuLU wins this round. I degrass or digress or whatever.

[caddis]

caddis, I'm in pharmaceuticals and I've sold in the respiratory market - you wouldn't believe the stories doctors have told me. Patients who keep the cap on because they don't like the taste of the medicine; people who spray the inhaler on their chest like it's vick's vapor rub. People are not always the brightest bulbs on the porch. I subscribe to Darwin's law on this one...let the stupid be stupid. We need to prune the genetic tree

[queenlillian1962]

Hello. The CFC thing has been in the works for at least 5 years. And people have died from Primatine Mist - that is not appropriate treatment. Sorry, but anyone with asthma needs to be treated by a doctor, they do not need to self medicate w/ over the counter drugs. Those are the ones who end up dead or in the ER. The pharma companies all have different delivery systems now so never fear, problem diverted. :)

The CFC thing has been a huge pain in the ass. But in reality it's simply cost pharma companies more because they had to come up with new delivery systems for the same meds.

In 1983 I was hospitalized with an asthma attack. One morning my doctor comes in and tells me his colleague lost a patient that morning. They too had been hospitalized with a Asthma attack. When you enter a hospital you are supposed to surrender or have someone take home any meds you keep on you like an emergency inhailer. Now this woman has been abusing Primatine Mist and the doctor told her to give up the inhailer because it was doing more harm than good, so she did. In a serious attack it takes a lot of time to feel better, I was hospitalized 10 days. Well when this woman didn't feel better by day two or three she begged her husband to bring her an inhailer. He did and she took it without the hospital staff knowing. It killed her. My doctor gave me this rule of thumb to go by. If you take the inhailer and it doesn't work the first time go to the hospital because it's not going to work,you don't keep taking it because you need better treatment. Then of course you have to be patient, there is no magic cure. Like I said it took 10 days before I was well enough to go home and honestly It took well over a year before I was anywhere near back to my old self because a bad attack makes your lungs sensitive.

Asthma patients need to see a doctor on a regular basis. Prevention is the best course of treatment when it comes to asthma. That being said, I gotta tell you since the got rid of the old inhailers the price did go up. This is not good as the high cost prevents people from getting what they need. The new inhailers IMO don't work as well as the old ones. Fortunately I found Advair does work well so I don't have to use Albuterol hardly at all now. What we need to do is make it affordable for patients with Chronic problems to see a doctor. I see a specialist when my asthma meds aren't working well. Once it's under control I see a GP every six months for a check up. My GP gets freebies from the pharmaceutical companies and gives them to those who can't afford the meds, it helps alot. The problem with people self medicating with OTC meds for asthma is when your suffocating to death you would swallow hot shit if you thought it would help you breathe again. Also use of inahailers can make hospital treatment less effective in an emergency. We need to find better meds for this disease and we need to cut levels of pollution because this disease is much more common now than when I was a kid.

[queenlillian1962]

caddis, I'm in pharmaceuticals and I've sold in the respiratory market - you wouldn't believe the stories doctors have told me. Patients who keep the cap on because they don't like the taste of the medicine; people who spray the inhaler on their chest like it's vick's vapor rub. People are not always the brightest bulbs on the porch.


WTF????:confused: Lack of oxygen can effect your thinking but not that much.

[Arkady]

It isn't that bad. The ones they have to buy are prescription only. They should make those available over the counter, and lower the price. Then no one would be affected.

[jwreck]

WTF????:confused: Lack of oxygen can effect your thinking but not that much.They were stupid before the lack of oxygen. ;)

[caddis]

Hey Lulu, I went to get my prescription for albuterol filled yesterday, since they had to "reformulated the delivery system" there wasn't a generic brand (even though they didn't change the medication) They wanted to charge me 45 bucks for the non-generic medication....that I have argue should be sold over the counter. So I walked out without paying...I guess I'll sacrafice my health to save the fucking ozone and keep sucking on empties and/or outdated medication until my brother makes another trip to mexico :nice:

[Lulu]

Yea, I'm not saying the system is perfect... that's more an issue with our healthcare system and insurance than the CFC thing though. Although, the CFC thing has prevented companies from making generic albuterol inhalers because they'd need to invest in research to create a new system to then sell albuterol inhalers (which has been off patent for at least a decade). Do you have insurance or do you pay cash for prescriptions? If insurance try a couple of things... find out which inhaler your insurance does cover at tier 1 or 2, call your doctor and have him write for that... Also see if they have coupons for the brand names (i.e. Proventil, Proventil HFA, Maxair, etc.) at the office. If not try this site... I think it's the one I've used before - they even have a $15 Proventil coupon from glancing. You usually need to call and activate these before you fill Rx.

http://www.internetdrugcoupons.com/Proventil-Coupon

If all else fails, see if you can't get nebulized albuterol... it's what the old folks use but it's usually dirt cheap. Not easy for transport but at least you'd have something in emergencies.

[Dreamy]

Interesting information Lulu. Insurance companies drive up the price of medicines. True? Years ago when people had to pay out of pocket no pharmaseutical company would dare charge the prices we see today.

[Lulu]

Interesting information Lulu. Insurance companies drive up the price of medicines. True? Years ago when people had to pay out of pocket no pharmaseutical company would dare charge the prices we see today.
Both pharma and insurance drive up the prices. Government has a role in it too. It basically works like this... pharma companies expect to make up the research costs + profit within 7-8 years (the average length of time of the patent once a drug reaches the market). They negotiate with insurance companies to get their drugs on the drug formulary so they will be used. Negotiating means a lot of money in rebates for the insurance company.... millions in rebates. So insurance co. says we will pay X for the drug but if this drug has a certain market share of the business, the pharma company will pay a huge rebate. That is why you see some drugs are on formulary or at a higher co-pay. It's in the insurance company's interest for people to use more of drug A if the rebate is higher. It's a win win for both but it inflates the price. The people who get screwed on this part is the patient who is paying cash. The system doesn't really account for these people.

Retail pharmacists usually get paid more to fill Rxs with generics. Insurance companies put this in so they can get as many patients as possible on generics even when the drugs may be the same cost.

Government is involved because whatever the pharmaceutical company is charging the govt. for the drug (Medicare & Medicaid), they are restricted on mark up in the retail market. I don't know the ins and outs of this because they keep it fairly vague for the rest of us.

I don't think it was like this years ago because insurance wasn't covering a lot of the meds. People simply paid cash. Once insurance and pharma got into it, the cash prices skyrocketed.

[86Dùde]

An out of control agency that should be carpet bombed out of existence.

[Lulu]

Caddis, a doctor told me this and I thought I'd pass along. Ventolin (name brand) is about $18 for an inhaler. He said it's the cheapest one.

[caddis]

Caddis, a doctor told me this and I thought I'd pass along. Ventolin (name brand) is about $18 for an inhaler. He said it's the cheapest one.I guess I should be thrilled that it's only 5 times more than it should cost....It's a great thing the EPA and the FDA are protecting our interests :)