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  (Source: Wordpress)
The FDA meets today to discuss the pill's effectiveness

Children with a rare lung disorder, called pulmonary arterial hypertension, may begin taking Pfizer Inc.'s drug Viagra in order to treat blood pressure-related problems associated with the disorder. 

Viagra is a drug normally used for erectile dysfunction and also helps adults with pulmonary arterial hypertension gain the ability to exercise by relaxing the arterial wall, which leads to decreased pulmonary arterial pressure and resistance. It blocks an enzyme that regulates flow in the penis and lungs.

This medication works for pulmonary arterial hypertension because what this disorder does is increase the blood pressure in the pulmonary vein, artery or capillaries leading to fainting, dizziness and shortness of breath. It causes the right side of the heart to work harder, and Viagra releases this pressure.

U.S. regulators are looking for a way to test whether Viagra would be okay for children. Advisors to the Food and Drug Administration will meet July 29 to discuss this matter and see if Pfizer's study on the pill's effectiveness on children is "sufficient."

Pfizer conducted a study that consisted of 234 children who took Viagra. In most studies of adults with the disorder, they are asked to perform exercise tests. However, this was much too difficult for the children, so a different test where a catheter is inserted through the arteries (which measures blood flow) was conducted instead. This alternative test proved that the drug failed to show any differences when the children tried regular exercise tests, but when researchers used the alternative measure of blood flow, Viagra did prove to be beneficial. 

"It's a good option in pediatric patients because it is well-tolerated, in that it doesn't have as many side effects as some of the other options," said Chad Knoderer, a pediatric clinical pharmacist at Riley Hospital for Children in Indianapolis, who has used Viagra for children with the disorder before.

Pulmonary arterial hypertension affects 600 people a year, and if Pfizer meets FDA requirements, the drug will be on the market an extra six months without generic competition. The patent for the drug is expected to expire in 2012. 



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I finally understand 2012
By torpor on 7/29/2010 1:57:56 PM , Rating: 2
So this is why the world ends in 2012...the Viagra patent runs out.

Imagine the affect on productivity if the world is hit with inexpensive ED drugs....we're doomed for sure!




RE: I finally understand 2012
By StevoLincolnite on 7/29/2010 9:29:26 PM , Rating: 2
quote:
So this is why the world ends in 2012...


Nope, the world ends because my plans of world domination using: A Camel, A piece of string and a Toothpick will finally become a reality!


RE: I finally understand 2012
By RedemptionAD on 7/30/2010 11:59:06 AM , Rating: 2
McGuyver is that you?


RE: I finally understand 2012
By topkill on 8/1/2010 5:27:51 PM , Rating: 2
Ok, everyone show some respect: Viagra, the gift that truly keeps on giving! ROFL


Misunderstanding
By whoisme on 7/29/2010 1:41:24 PM , Rating: 3
All viagra does is increase the amount of nitric oxide in the body through the use of the chemical L-Arginine (and various other chemical and forms of L-Arginine). As some of you and the article said it loosens up the walls of the circulatory system, and increases blood flow. I wouldn't be to worried about giving it to kids, in fact I take L-Arginine everyday in a workout supplement.




RE: Misunderstanding
By Noya on 7/29/10, Rating: 0
RE: Misunderstanding
By tmouse on 7/30/2010 9:39:00 AM , Rating: 2
Thanks for sharing


Child with PPH and pulmonary atresia
By Strawberree on 7/29/2010 5:59:00 PM , Rating: 3
My infant daughter has been on Viagra for nearly a month due to pulmonary hypertension after a repair of her cardiac defect. While I am very grateful for the medicine, which showed an immediate improvement in her pulmonary pressures, I am very disappointed by how artificially expensive her medicine is. I cannot believe how expensive it is, and that Pfizer is making a killing off of my insurance company. There needs to be a generic version of this drug, particularly for children!




By Wiredog on 8/17/2010 1:43:18 PM , Rating: 2
God bless you. My son had PAH and was on sildenafil citrate (Viagra) for the majority of the 2.5 years he survived after diagnosis. As you can see from the other comments, many do not understand what the medication was originally meant for (smooth muscle dilator) and will make all sorts of rude comments.

I will continue to pray for your daughter and all other children with PAH. We must find a cure so no other mother or father has to go through what we have.


Are you sure it is not Revatio?
By apc31981 on 7/29/2010 3:54:43 PM , Rating: 2
Revatio is already approved for PPH in adults and is available in a more appropriate dose (20 mg PO TID).
Viagra is only available in 25, 50, and 100 mg tabs that have no additional blood pressure lowering benefit and just leads to additional headaches.

PPH (or PAH) is a pretty serious disease with an average life expectancy of 2 years post-diagnosis. The most common cause is Phen-Fen use.

And yes, I have sold Viagra (Revatio wasn't available)to one of my high school classmates who was unfortunate enough to have cancer and her chemo caused PPH. She expired when she was only 17.

I am a Pharm.D. RPh




RE: Are you sure it is not Revatio?
By JAB on 7/30/2010 10:20:34 AM , Rating: 2
I think you are a little confused there. IPAH is rare but pulmonary hypertension is common sequelae of CHF liver failure and morbid obesity. IPAH hasn't had a 2 year prognosis in 20 years or more.


Who recalls?
By YashBudini on 7/29/2010 10:31:11 PM , Rating: 2
quote:
My dear family, guess what. Today I found out what my special purpose is for.




Say what!?
By solarrocker on 7/29/10, Rating: -1
RE: Say what!?
By Brandon Hill (blog) on 7/29/2010 12:35:32 PM , Rating: 4
[Quagmire] "Dear diary. Jackpot!" [/Quagmire]


RE: Say what!?
By dreddly on 7/29/2010 1:28:48 PM , Rating: 2
Where's pedobear! I thought that would have been the main image for sure...


RE: Say what!?
By amanojaku on 7/29/2010 3:03:38 PM , Rating: 2
Pfft. Toy Story gifts are more disturbing than kids taking Viagra.

Little girl: I've got a Buzz!
Little boy: I've got a Woody!
Herbert Garrison: Look at how much stuff I can fit in Mr. Potato Head's rear compartment!

Harry Potter toys are even worse: vibrating broomsticks!


market extension is a bit sad
By GrandMareg on 7/29/10, Rating: -1
RE: market extension is a bit sad
By Ticholo on 7/29/2010 12:31:44 PM , Rating: 2
Completely off-topic:

I wonder what you mean by "obvious side effects"... ;)


By bubbastrangelove on 7/29/2010 12:37:55 PM , Rating: 5
Side effects may include:

- Excessive use of peanut butter and prolonged absences of household pets
- Refusal to take part in standing activities
- Destroyed warm apple pies


RE: market extension is a bit sad
By Smilin on 7/29/2010 2:44:02 PM , Rating: 2
He's probably talking about the low incidence of blindness found during on-label use.


RE: market extension is a bit sad
By BruceLeet on 7/29/2010 1:14:44 PM , Rating: 4
Somebody pleease think of the children!


By Spivonious on 7/29/2010 1:23:16 PM , Rating: 2
hehe "longer extension"


RE: market extension is a bit sad
By sgw2n5 on 7/29/2010 1:25:44 PM , Rating: 1
This is absolutely correct, and a disgusting business practice.

Phizer has successfully conducted trials using "viagra" for treating this disorder as early as 2001. They sat on it for nearly 10 years (while children who could have used the medication were either dying or living in misery) and then when the patent is ready to expire on viagra, they "invent" a pill (basically a small dose viagra) that helps this disorder. They patent the "new" drug for another 10 years.

Companies only exist to make money, I get that, but this is beyond dirty.


By Spivonious on 7/29/2010 4:28:26 PM , Rating: 3
Perhaps if the U.S. copyright system made sense, this sort of corporate behavior wouldn't be encouraged.


RE: market extension is a bit sad
By PCR on 7/29/2010 1:48:35 PM , Rating: 2
Yes I think you are right, drug companies employ these tactics all the time. However, Viagra was initially being developed to treat pulmonary hypertension. During Phase I clinical trials it was discovered that Sildenafil (Viagra) could induce penile erections. In the end Pfizer decided to market it as an erectile dysfunction drug, it was a purely financial decision as not that many people suffer from pulmonary hypertension.

Viagra could very well treat pulmonary hypertension since it targets cGMP-specific phosphodiesterase type 5 enzyme (PDE5), this enzyme is mostly found in the arterial walls of the lungs. So theoretically it could induce vasodilation in the lungs.


RE: market extension is a bit sad
By Smilin on 7/29/2010 2:23:37 PM , Rating: 2
quote:
Pfizer is just doing whatever it can to extend how long it can keep Viagra on the market without competition.

It already has competition. But sure that's a reasonable thing for a company to do anyway.
quote:

1. find any condition
2. see if drug has any effect whatsoever on the condition
3. get a longer extension on a drug that isn't even that beneficial and has obvious side effects.

Am I missing anything?


Yes. #3 is all wrong.

You're talking about demonstrable benefits and the side effects are not out of line.

#1 and #2 are completely normal practice for drug companies and if they didn't do this it would be a shame.

Keep in mind that the on-label use of this drug is itself a side effect of it's behavior. The effects on the cardiopulmonary system are significant and relatively safe. The on-label use is one way to leverage the effects but there are surely others.

Why ignore a functional medical tool just because it's associated with making tools functional eh?

Would you suggest we deliberately ignore a potentially treatable medical condition just because people are uptight about sexuality? Grow up.


By Unspoken Thought on 7/30/2010 3:50:54 PM , Rating: 2
The first 2 would be great if it weren't for the fact that Big Pharma goes for the quickest fix and most amount of money. They disregard any potential drug if they don't have a patent on it. Drugs get passed in such a rushed manner by "organizations" such as the FDA who end up being run by lobbyist. All the above is "normal" practice. We've had recalls on drugs just because they appear to do something without even knowing how it works. SSRIs are a perfect example. We're the mice, only difference is we hand them cash and receive anal leakage in return. Thank you, come again. No pun intended.

I find humorous that inside the box for all of these prescription medications is a huge fold out with 50% chemical data and 50% side effects. I ask the individual if they even read it or just continue drinking the kool-aid.

quote:
Would you suggest we deliberately ignore a potentially treatable medical condition just because people are uptight about sexuality? Grow up.


You would be pretty good at writing fiction.


"I modded down, down, down, and the flames went higher." -- Sven Olsen

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