Would Aspirin be approved by the FDA today?

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@Qadgop the Mercotan

Lots have been taken. And I’ve had a lot of folks with GI bleeding too.

Aspirin is great in low doses, 81 mg a day for example, to reduce heart attack risk. I prescribe it a lot for that.

But I don’t recommend it a lot in higher doses, due to its complication rate.

I’ve also treated a number of folks with severe allergic reactions to aspirin, which is much more common than reactions to tylenol or ibuprofen. Some were close to death until they responded to emergency treatment.

It’s a very helpful drug, but its risk profile is rather significant too.

[slight, quick hi-jack]What do you think of this recommendation by Dr. Mehmet Oz?

What men should eat every day

6. If there’s a true magic pill, Dr. Oz says it could be baby aspirin. “It’s cheap and easy to take aspirin,” he says. “Aspirin has many, many helping elements. It helps your skin, it helps about anything you can imagine. It has some potential risks if people have sensitive stomachs. But for cancer, you’ve got to be on it.”

A man over 35 should take two baby aspirin --or 162.5 milligrams --every day. It can reduce his rise of arterial aging by 36 percent.

Do you think that’s a good blanket recommendation for men over 35, or do the possible drawbacks outweigh the possible benefits?[slight, quick hi-jack]

[mnemosyne]

@David Simmons

I don’t think that was the point of the OP. The definite statement was,This was followed up by scotandrsn’s post which had this cite,

Hmm… rereading the thread, I’m not sure what I thought “the point” was when I wrote that sentence!

Perhaps I just meant to say that it wouldn’t be approved for common use (for the purposes and with the OTC availability that it actually has), so in that way, the article is (maybe) right. But no, I don’t think it would have died in a lab.

So… I guess I agree with you!

[Jake]

I’ve been taking one baby asprin, as prescribed, for years now. What’s with doubling the dosage? Qad, I’d really appreciate your input.

[Rube_E.Tewesday]

@Jake

I’ve been taking one baby asprin, as prescribed, for years now. What’s with doubling the dosage? Quad. I’d really appreciate your input.

Same here. I read an article years ago that said there was an advantage for those taking one baby aspirin a day to take a full aspirin every month or so, but nothing saying that the standard should be two babies a day.

[Qadgop_the_Mercotan]

I am unaware of any evidence saying that more than 81 mg (typical ‘baby’ aspirin dose) is more beneficial. There is some fairly good evidence that shows more aspirin raises risks of complications of aspirin.

Be aware that aspirin is recommended for those at increased risk of heart disease, not as a drug for anyone and everyone.

As this link shows, the benefits of daily aspirin outweigh the risk when the risk is elevated.

If a large population has a 1% risk of a coronary event in the next 5 years, and takes aspirin every day, over that 5 years, for every 1 to 4 coronary events that aspirin prevents, there will be 0 to 2 hemorrhagic strokes and 2 to 4 major GI bleeds that occur because of the aspirin use. Dubious benefit versus the risk.

But if the risk of a coronary event is 3%, that changes to: for every 6 to 20 coronary events prevented by aspirin, there are those same 0 to 2 hemorrhagic strokes and 2 to 4 major GI bleeds caused by aspirin. A marked benefit versus the risk.

[x-ray_vision]

Thanks for that excellent reply including facts and figures, QtM. I think I’ll pass on Dr. Oz’s advice to take that fairly high dose of aspirin just because I’m over 35, yet have never been found to be in any high risk groups.

[Koxinga]

Is it true that nobody knows how aspirin “works” to alleviate pain, just that it does?

[x-ray_vision]

@Koxinga

Is it true that nobody knows how aspirin “works” to alleviate pain, just that it does?

According to this article, it was figured out in the early 70s.

How does ASA reduce pain and inflammation?

Despite being used since the turn of the century, it wasn’t until the early seventies that it was discovered how aspirin works. ASA binds to an enzyme called cylooxygenase-2 in cells. This is produced in large quantities in cells which are damaged and so cause pain. Without the presence of ASA this enzyme makes chemicals called prostaglandins which send messages to the brain that part of the body is in pain. They also cause the area that has been damaged to release fluid from the blood so that it will swell up or inflame. This protects the damaged cells from further damage by creating a cushion. When aspirin is taken the enzyme is no longer able to make prostaglandins and some of the pain messages don’t get sent to the brain, so we feel less pain. Also the areas don’t inflame as much and inflammation is reduced.

[Anaglyph]

@x-ray vision

According to this article, it was figured out in the early 70s.

See the PDB Molecule of the Month for an explanation of the molecular mode of action of Aspirin

[Cheesesteak]

Today, we already have 3 non-aspirin over the counter pain relievers, adding aspirin to the mix when it has more severe side effects makes no sense. In the lab you’d be saying “Ok, this is kind of like Acetaminophen and Ibuprofen, but with worse side effects. I’m not seeing that as a real winner.”

However, when aspirin came out, the only other option for pain relief was potentially addictive opiates. Under those circumstances, I can see why we would be in favor of approving a non-addictive non-opiate pain reliever, and making it readily available, even with the FDA being hard-asses.

In other shocking news, the Model T would not meet today’s emissions and safety regulations, and would probably not even pass the design stage.