CNN: FDA approves inhaled insulin for diabetics

[DeepModem Mom]

FDA approves inhaled insulin for diabetics
Friday, January 27, 2006


WASHINGTON (AP) -- The first inhalable version of insulin won federal approval Friday, giving millions of adult diabetics an alternative to some of the regular injections they now endure.

The Food and Drug Administration said the Pfizer Inc. insulin, to be marketed as "Exubera," is the first new way of delivering insulin since the discovery of the hormone in the 1920s. Pfizer jointly developed the drug and dispenser with Sanofi-Aventis and Nektar Therapeutics.

Use of rapid-acting inhaled insulin will not replace the need to occasionally inject the hormone, according to the FDA. And diabetics will have to continue pricking their fingers to test blood sugar levels.

The FDA delayed its decision by three months so it could review chemistry data on the diabetes treatment. The European Commission approved Exubera for use in adults on Thursday.

Analysts have said the inhaled insulin could eventually become a $1 billion-a-year seller for Pfizer, which recently agreed to pay Sanofi-Aventis $1.3 billion to obtain full worldwide rights to the drug for use by both Type 1 and 2 adult diabetics....


http://www.cnn.com/2006/HEALTH/01/27/inhaled.insulin.ap/index.html

[boobooday]

1. I take insulin

This "blows" my mind.

Seriously. Right now I wear a pump . . . I can just see my life with inhalable insulin . . .

Time for dinner? Wait a minute . . . gotta get a SNORT.

Saying goodbye to needles would be nice, although this wouldn't do away with all of them.

[DeepModem Mom]

2. I hope this will help, boobooday! nt

[boobooday]

5. Thanks!

My pump manufacturer tells me that soon it will be able to monitor the glucose constantly. That would make it like an external artificial pancreas.

It's been 27 years for me, and I've seen a lot of amazing advances. Looks like lots of exciting stuff coming up.

[Tesha]

3. Stick-free glucose testing on the way!

> And diabetics will have to continue pricking their fingers to test blood sugar levels.

New Scientist magazine this week reported on a blood-free
method of glucose testing. IIRC, it uses a particular frequency of
light (which might be infrared) to directly measure the amount of
glucose circulating in certain very thin capillaries in the white of
the eye.

This would probably make a lot of diabetics very happy.

Tesha

[boobooday]

4. I can see it in the whites of yer eyes . . .

Whoa.

The end of the sticking would be very nice.

[cdsilv]

6. EMS techs and hospitals use this method TODAY! (n/t)

...that is they have some sort of thingie that uses light and clamps on your index finger to monitor blood sugar. It's connected to a box about the size of a small cinder-block.

I've had it used on me.

[caligirl]

10. Pulse oxymeter. measures O2 saturation of blood in capillaries.

Always used in recovery room. I first started using this in 1985 when I worked PAR.

[kineneb]

7. Hubby will be interested in this

He Hates giving himself insulin, and all the finger sticking, as he is somewhat phobic about needles.
Bet Medicaid/Medicare won't cover it?

[Dont_Bogart_the_Pretzel]

12. ditto

Bet Medicaid/Medicare won't cover it?

[IDemo]

8. Going on 45 years as type 1, and won't be snorting insulin anytime soon

This is great for those who abhor needles to the point that they are unable to control their BG (blood glucose levels). But it means inhaling insulin in a powdered form, which may be unsuitable for smokers or those who suffer from asthma, according to the FDA.

An account from a diabetic who participated in a clinical trial stated that he had begun to experience decreased lung capacity after several months, although he was neither a smoker or asthmatic.

I'll "stick" with the needles!

[DeepModem Mom]

9. Interesting, IDemo. Thanks for sharing your knowledge of this subject...

and best to you.

[DeepModem Mom]

11. A NYT (page-one) article addresses this issue of risk to lungs --

"But some doctors say they are concerned that Exubera's risks to the lungs have not been properly tested, especially because Exubera works no better than injected insulin at controlling blood sugar. In clinical trials, Exubera caused a slight reduction in patients' ability to breathe.

The Food and Drug Administration is recommending that patients have their lung function checked before starting Exubera and every 6 to 12 months afterward."

http://www.nytimes.com/2006/01/28/health/28diabetes.html?_r=1

[Colorado Blue]

13. A friend wanted me to share this with you:

This is from an email news update from diabetesincontrol.com and is not yet on their site:

Dr. Richard K. Bernstein has mixed opinions. “It might be of benefit for type 2’s who are making a lot of their own insulin and help them with their meal time blood sugars or if they need a small dose for the dawn phenomenon. It will not be of benefit for those with Type 1 diabetes, because it will not allow them to get precise control. You will not be able to use if for Type 1 or Type 2’s who are on large doses of insulin."

"When inhaling insulin the unpredictability will be a major negative factor in using it."

"Small doses of injected insulin is very predictable and any doses of inhaled insulin is far less predictable in its effects upon blood sugar due to the changes in the mucosa. If you have cold or the flu, or congestion, it will effect the absorption."

"The current studies with inhaled insulin have showed some unpredictability in absorption. So for those with Type 1 diabetes, it could be very dangerous because of its unpredictability."

[DeepModem Mom]

14. Thanks to you, and your friend, CB, for this additional info. nt