Mr. Asthma

Question:

Hi Jim, I called another of my physicians this mourning. The nurse called me back this evening and I mentioned my situation. She said I could stop by in the mourning to big up a treatment package (should last two months). The only thing she requested from me was feedback in the use/results of use of the Pulmicort. I gladly accepted her terms. I would suggest that you contact your physician as soon as possible because I think the resources will dry up until the drug is released again for distribution. You might if try for a referral to another physician by your PCP, doesn’t hurt to try. — Regards and God Speed, Gary W. Sandvik : I knew it wasn’t available right now, but I didn’t know I might have to : wait until the end of January. This is the only inhaler I’ve used that : seems to help. Inhalers such as Flovent, Asthmacort, etc. initiate a : coughing spell for me. The coughing is caused by the propellant, not the : drug. My doctor thinks the cough prevents the inhaler from being effective, : since I probably cough most of it back out. : To me Pulmicort has been a Godsend. I’ve only been on it a few weeks and : (if this continues) I seem to be more under control than in two years. : : I’ll have to see if he is willing to give me another sample so I don’t run : out before it hits the shelves. : : Jim : : > Hi, : > : > I’ve been prescribe to take Pulmicort 3 BID but the pharmacies cannot get : > the drugs from the warehouse until 01-28-98. This is due to the : > reformulation enforced by the FDA. : > : > :

Response:

>Hi, >Do you know when this occurred in New Zealand? Can you give me some >detailed information?- >Regards and God Speed,

Sometime in the mid eighties.  Email me a reminder in a couple days and I’ll look up the rest of the info. ‘Reply to’ address changed to foil email spammers.

Response:

I knew it wasn’t available right now, but I didn’t know I might have to wait until the end of January. This is the only inhaler I’ve used that seems to help. Inhalers such as Flovent, Asthmacort, etc. initiate a coughing spell for me. The coughing is caused by the propellant, not the drug. My doctor thinks the cough prevents the inhaler from being effective, since I probably cough most of it back out. To me Pulmicort has been a Godsend. I’ve only been on it a few weeks and (if this continues) I seem to be more under control than in two years. I’ll have to see if he is willing to give me another sample so I don’t run out before it hits the shelves. Jim – Hide quoted text — Show quoted text -> Hi, > I’ve been prescribe to take Pulmicort 3 BID but the pharmacies cannot get > the drugs from the warehouse until 01-28-98. This is due to the > reformulation enforced by the FDA.

Response:

The drug involved in deaths in New Zealand was formoterol, a long-acting bronchodilator. A similar problem was noted in a Canadian study which included not only formoterol but albuterol aka salbutamol, a  bronchodilator used in the US. Here is a link: http://www.infomed.org/pharma-kritik-e/pk95_5e.html                      Beta-adrenergic Agonists and Asthma Deaths Excerpt: "In recent years beta-adrenergic agonists, particularly isoprenaline  and fenoterol, have been associated to an increased asthma mortality.  In New Zealand a steep increase of asthma deaths was observed in  conjunction with the introduction of fenoterol. Three case control  studies have been carried out with fenoterol in that country. The  first study (117 cases, 468 controls) demonstrated that individuals  with severe asthma using the fenoterol aerosol and who had been  hospitalized in the past had a higher risk of mortality than patients  in the control group who did not take fenoterol. The second  (58 cases, 227 controls) and third studies (112 cases) reached the  same conclusions: fenoterol increases mortality in patients with severe  asthma bronchiale. In a Canadian study (129 cases, 655 controls) a  higher risk for life-threatening or lethal asthma attacks was observed under fenoterol as well as under salbutamol." Here is a link to similar problems in Canada. http://www.sma.org/smj/97feb2.htm Potential for Tolerance, Morbidity, and Mortality Resulting From Regular Use of b2-Adrenergic Agonists in Asthma Ellis – Hide quoted text — Show quoted text – > Do you know when this occurred in New Zealand? Can you give me some > detailed information?- > Regards and God Speed, > Gary W. Sandvik > : >I believe that Pulmicort has been used for over a decade in Europe without > : >major problems. So what gives? I spoke with my PCP today and he stated > that > : >this can be the norm. The FDA is controlling an established drug! What > if > : >the forced formulation causes a problem? Can we asthmatics come back on > the > : >FDA? > : Those countries do not have the strict standards of the US in terms of > : demonstrated safety and effectivness.  It takes longer for a durg to > : be approved in the US (and many drugs used overseas do not meet US > : safety standards) but it is recognised that as a consequence the > : pharmicuticals in the US are the best and safest in the world. > : There was an epidemic of asthma deaths in New Zealand where the > : victims were using a bronchodilator (I forget the name) that was not > : approved for US use due to safety concerns.

Response:

>I believe that Pulmicort has been used for over a decade in Europe without >major problems. So what gives? I spoke with my PCP today and he stated that >this can be the norm. The FDA is controlling an established drug! What if >the forced formulation causes a problem? Can we asthmatics come back on the >FDA?

Those countries do not have the strict standards of the US in terms of demonstrated safety and effectivness.  It takes longer for a durg to be approved in the US (and many drugs used overseas do not meet US safety standards) but it is recognised that as a consequence the pharmicuticals in the US are the best and safest in the world. There was an epidemic of asthma deaths in New Zealand where the victims were using a bronchodilator (I forget the name) that was not approved for US use due to safety concerns. ‘Reply to’ address changed to foil email spammers.

Response:

Hi, Do you know when this occurred in New Zealand? Can you give me some detailed information?- Regards and God Speed, Gary W. Sandvik : : >I believe that Pulmicort has been used for over a decade in Europe without : >major problems. So what gives? I spoke with my PCP today and he stated that : >this can be the norm. The FDA is controlling an established drug! What if : >the forced formulation causes a problem? Can we asthmatics come back on the : >FDA? : : Those countries do not have the strict standards of the US in terms of : demonstrated safety and effectivness.  It takes longer for a durg to : be approved in the US (and many drugs used overseas do not meet US : safety standards) but it is recognised that as a consequence the : pharmicuticals in the US are the best and safest in the world. : : There was an epidemic of asthma deaths in New Zealand where the : victims were using a bronchodilator (I forget the name) that was not : approved for US use due to safety concerns. : : : : ‘Reply to’ address changed to foil email spammers. :

Response:

>I’ve been prescribe to take Pulmicort 3 BID but the pharmacies cannot get >the drugs from the warehouse until 01-28-98. This is due to the >reformulation enforced by the FDA.

If you can’t get the sample pack to get you through until the end of January, you might ask about switching to Flovent for now. It has done rather well in the U.S., is available now, and is available in three dose strengths to accomodate different severities of asthma. Then, if you are having good results, you can stay on Flovent or switch back to Pulmicort. Donald Hellen There is someone out there for everyone, even if you need a pick axe, compass, and night goggles to find them. -L.A. Story

Response:

I spoke with a salesman for the company that makes Pulmicort just last week.  He was in my doctor’s office delivering pulmicort sample packs.   He said that they didn’t release the pulmicort as planned because there was more demand for it than there was pulmicort already manufactured and in place.  They are delivering these packets to doctors to be given to patients to get them through till January when the pulmicort is available at your pharmacy. You might give your doctor a call and see if they have any of these packets.  They are supposed to be a 2 month supply. Loki > Hi, > I’ve been prescribe to take Pulmicort 3 BID but the pharmacies cannot get > the drugs from the warehouse until 01-28-98. This is due to the > reformulation enforced by the FDA. > I was told that the drug had been released for distribution Oct/97 in the > U.S. True??

[snip]

Response:

Hi, I’ve been prescribe to take Pulmicort 3 BID but the pharmacies cannot get the drugs from the warehouse until 01-28-98. This is due to the reformulation enforced by the FDA. I was told that the drug had been released for distribution Oct/97 in the U.S. True?? I’m not talking about the asthma study periods for this drug. I tried to get into a program just to get it but the Doctor stated that my stability was at risk since it would be a blind study. Quess what, no pulmicort! Even when I was at National Jewish in  early Sept/97, the Drs’ said it would be available. I believe that Pulmicort has been used for over a decade in Europe without major problems. So what gives? I spoke with my PCP today and he stated that this can be the norm. The FDA is controlling an established drug! What if the forced formulation causes a problem? Can we asthmatics come back on the FDA? This should be changed! This is a free society and we have people<FDA>, that think they know what’s best. I admit we do need some regulation/control but to question a known working drug because it is not controlled by a major pharmaceutical in the U.S. And if you do not think the U.S. manufactures control the license of drugs in the U.S. (and I am saying the lobbyist are controlling the FDA indirectly), then come to Peoria to buy some of this river front property that is for sale (water rights included). With asthma controlling my daily life and the possiblility of a maintenance drug to improve me or even provide a better administration drug to allow me to continue. Any help would be appreciated. — Regards and God Speed, Gary W. Sandvik

Response:

Hi! I do not have a REALLY bad case of asthma, nor is it particularly light.   At present, my doctor has me on Pulmicort and Ventolin.  I am to take the Pulmicort regularly, and Ventolin when I need it.  I used to be a Ventolin addict (about 6 times daily – too much for me), but now I’m down to at MOST 1 puff per day (unless around dogs or cats).  I started with the Pulmicort, recognizing this addiction (my doctor recommended this).   I started with 2 puffs, four times daily, and now I take 2 puffs when I wake up, and that’s it.  So the question I have is- is Pulmicort better for your health than Ventolin?  How?  Does it have any side affects?   Does Ventolin?  I am away from home, so I can’t really ask my doctor (and don’t have time to go to another- I work obscene hours). Thank you very much! Marcus Scrimgeour

Response:

Pulmicort is an excellent drug & is used to prevent asthma for the long term. Ventolin is used to treat symnptoms. I would recommend however to use your Pulmicort twice daily. Using a PEFR meter measuring your peak flows twice daily AM & PM would be extremely useful in monitoring your condition. 1-800-456-asthma is a free excellent resource. Good luck! Remember to use your Ventolin for emergency times and prior to exercise.

Response: