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Thursday, May 21, 2009
Columbus company to develop an inhaler, potential alternative to IVs : MedCity News
Please pass this info along to all of your friends and family.
ReplyDeleteOzone-friendly inhalers could face early demise
http://www.journalgazette.net/article/20090330/BIZ/303309942/1031/BIZ
Benefits vague, problems clear in inhaler ban
http://www.journalgazette.net/article/20090330/BIZ/303309941
Asthma Patients Outraged at Indifference to Problems with New Inhalers:
http://www.consumeraffairs.com/news04/2009/02/asthma_hfa02.html
Olympian Jackie Joyner-Kersee: FDA "Insensitive" to Asthma Patients' Problems:
http://www.consumeraffairs.com/news04/2009/03/asthma_hfa04.html
The number of patient complaints is skyrocketing:
http://www.consumeraffairs.com/health/hfa_inhalers.html
Read the thousands of complaints at this petition:
http://www.ipetitions.com/petition/saveCFCinhalers/signatures.html
Patients at askapatient.com are reporting HFA inhalers as "useless" with a rating of 1.2 on
a scale of 1 to 5 with 5 being the best and 1 being the worst:
http://www.askapatient.com/viewrating.asp?drug=20503&name=PROVENTIL-HFA
You can only wonder if the FDA is trying to kill asthmatics:
http://www.opednews.com/populum/diarypage.php?did=11627
Also worth mentioning from the FDA website is the fact that a manufacturer of one of the HFA
inhalers admits in it's own new drug application to the FDA that it's HFA based albuterol is less
safe and effective than it's CFC based albuterol:
http://www.fda.gov/cder/foi/nda/2001/20-983_Ventolin-HFA_medr_P1.pdf
These quotes taken directly from the new drug application for Ventolin HFA.
"In the multiple dose adolescent and adult studies, albuterol HFA showed a numerically smaller
improvement in FEV1 than was seen with albuterol CFC"
"There was other evidence that the HFA formulation delivers a lower/less effective dose on a per
acutation basis than the CFC product. In the single dose, dose ranging study in adults, and in
the single dose methacholine challenge study in adults one and two acutations of albuterol CFC were
statistically indistinguishable in terms of effect, whereas significant differences were seen
between one and two acutations of albuterol HFA. Finally, the combined adolescent/adult studies
showed that the HFA formulation had a longer median time to onset of effect(4.2-9.6 minutes
versus 3.6-4.2 minutes), had a shorter duration of effect(1.55-3.30 hours versus 2.29 - 3.69
hours), and was associated with more albuterol 'back up' use than the CFC formulation."
"We note that in the two 12 week clinical trials in adolescents and adults, Ventolin HFA
Inhalation Aerosol consistently showed a smaller effect size than Ventolin CFC Inhalation
Aerosol"
"Because it is expected that many physicians will prescribe Ventolin HFA Inhalation Aerosol for
patients who have previously used the CFC formulation, it would be appropriate to include some
description of the relative effectiveness of these two formulations in the product label."
"Unfavorable changes in physical examinations were observed in the ears, nose, and throat category
as follows: 8% placebo HFA; 13% albuterol HFA; and 5% albuterol CFC."