Would Aspirin be approved by the FDA today?

I just received this “factoid” (in a long list.)

Aspirin would not gain FDA approval if it were introduced today.

I’m not sure this can be definitively answered, but I don’t think the question goes in any other forum.

Here’s an article from a couple of years ago on this very subject

That’s an interesting article. Thanks for the link.

I can think of at least one other reason it’d never get approved. It’d be sold instead as a “willow bark extract dietary supplement”, which wouldn’t need approval. Nobody would have even found out about the risks of digestive problems, at least until someone famous died of it.

It might be approved, but then only as a prescription medicine. In fact, I think a good case can be made to change its status to ‘by prescription only’ even now.

As mentioned, it has rather predictable, and potentially catastrophic effects on the stomach and upper small intestine (duodenum). In addition, though, it can aggrevate both kidney malfunction and high blood pressure. Likewise, as with all so-called ‘Non-Steroidal Anti-Inflammatory Drugs’ (NSAIDs), it can worsen or precipitate heart failure.

OTOH, it’s about as good as it gets in terms of preventing strokes and heart attacks for people who’ve already experienced either (or their warning signs). For this reason alone, I wouldn’t throw the aspirin baby out with the bath water.

Can you imagine the lawsuits in the 2010s after the first Reye’s Syndrome cases? If aspirin were approved in 2008, it would be gone by 2012.

In my non-medical, non-lawyer opinion, that is.

Aspirin hasn’t been made from willow bark since 1853, when Charles F. Gerhardt first synthesized salicylic acid, the pre-cursor to aspirin. I don’t think synthetic chemicals can be marketed as dietary supplements.

I think the “drug discovery researcher” has an axe to grind. Maybe his latest whiz bang drug is having a hard time with the FDA.

Many drugs with side effects as serious if not more so than aspirin are actually on the market after receiving FDA approval.

I’m thinking right now of all those that can result in serious liver damage and you must have regular tests for such damage when to take the drug.

Come to think of it, I used to take warfarin which has been approved.

In order to properly regulate the dosage I had to have blood viscosity tests every week. The dosage was juggled until they finally got what they thought was correct. Then blood tests once a month as a constant check. One day after a test I got a hurry-up call from the doctor’s office telling me to stop warfarin immediately.

So I told the doctor that despite the “warfarin is twice as good as aspiring” line, I was going back to aspirin. He said that he didn’t blame me.

Nobody can tell me that if things like Lipitor, Clelebrex and Cumadin (warfarin) are approved that aspirin wouldn’t make it.

Isn’t Salycilic acid REALLY hard on your stomach. Like hard enough that it’s not worth taking without the aceatyl acid tacked on?

Salicylic acid preparations were slow to catch on in the 19th century because the gastrointestinal side effects were considerably worse. The formulation of acetylsalicylic acid is what made the drug safe enough for millions to take on a regular basis.

If aspirin had not been developed, people would have been far more dependent over the years on less acceptable alternatives like morphine and its derivatives.

That’s why aspirin is acetylsalycilic acid. That acetyl group makes it a lot less hard on the stomach than the raw acid would be.

I think that’s the point, though. While I think aspirin would be approved today for treatment of specific illnesses, it would be with the types of blood tests and follow-ups that other harsh but effective meds have. Aspirin would never make it to over-the-counter, let alone off-the-shelf.

Probably the most unacceptable thing that has been “grandfathered” into current use is amalgam tooth fillings. Try to get an implant containing mercury metal approved today!

If anything, this shows the ridiculousness of this whole ‘approval’ process.

Aspirin has been used by millions of people, for well over a century, with successful results. And bad reactions occur so seldom that people can remember them and post many of them here.

If any drug has been proven to be “generally recognized as safe” by actual, real experience, surely aspirin has.

Are you basing your opinion above on actual data, or anecdote?

Actual data.
Millions, even billions of doses of aspirin have been sold, and presumably consumed, since its introduction. And the reports of bad reactions are a miniscule proportion of that. How many thousand tablets have been taken at your prison during your employment there?

It’s one of the most common drugs used in this country.

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.

Amalgam fillings would probably get more scrutiny before entering standard practice in the current regulatory climate, but that’s not because they’re “unacceptable”.

Repeated studies backed by clinical experience have shown they’re safe, and the sorts of people who engage in noisy anti-amalgam advocacy tend to be obsessed with other non-scientific health fears over things like water fluoridation, aspartame and vaccination - in other words, quackery.

We now return you to your regularly scheduled question/debate: “Aspirin - Panacea or Peril?”

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,