Thursday, May 21, 2009

Columbus company to develop an inhaler, potential alternative to IVs : MedCity News


Anonymous Anonymous said...

Please pass this info along to all of your friends and family.
Ozone-friendly inhalers could face early demise

Benefits vague, problems clear in inhaler ban

Asthma Patients Outraged at Indifference to Problems with New Inhalers:

Olympian Jackie Joyner-Kersee: FDA "Insensitive" to Asthma Patients' Problems:

The number of patient complaints is skyrocketing:

Read the thousands of complaints at this petition:

Patients at 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:

You can only wonder if the FDA is trying to kill asthmatics:

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:

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


"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."

June 3, 2009 at 10:29 PM  

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