
Ibuprofen May Not Be as Safe as was Thought - metafunctor
http://time.com/4568552/ibuprofen-naproxen-inflammation-safety/
======
dahart
Honest question, is it possible this article or the study it mentions is a
paid ad for Celebrex? It somehow feels more pushy than impartial, and it
didn't mention the cost difference between Ibuprofen and Celebrex, which is to
put it mildly, enormous.

I have taken too much "Vitamin-I" over the years, and it finally caught up
with me and started causing stomach and esophagus problems. I've wanted to try
Celebrex, but it's way too expensive. Have tried Meloxicam and it's much
gentler than Ibuprofen, but let's just say it did come with some side effects
on my gastrointestinal system.

~~~
NTripleOne
I mean, it's literally in the article that pfizer had to pay for the study, so
it wasn't exactly impartial from the start.

~~~
wtvanhest
I was in Florida visiting family over the weekend and this exact study was
mentioned by the local news with a series of interviews. It was completely
obvious that it was a commercial and nothing more.

One of the key things that tipped me off was that they compared "prescription
strength" Ibuprofen to Celebrex once, then didn't mention it again. I get that
it is like for like (prescription for prescription), but the vast majority of
people taking Ibuprofen are not taking prescription strength dosages.

This should not be "news" it should be given to doctors to consider. We
probably need a medical body to review these types of papers to determine
whether they are actionable by medical professionals.

~~~
zymhan
A prescription strength dose is only 3 normal ibuprofen tablets. That is an
extremely common dose for people to take on their own with OTC ibuprofen, but
it is also prescribed by a doctor in a single pill for convenience and to make
it easier for insurance to cover it.

The point of the study is to compare long-term, daily use of NSAIDs. It isn't
saying that you should take Celebrex for a headache (nor could you as it
requires a prescription).

You shouldn't be so quick to dismiss a study that you think is "obviously a
commercial" if you aren't familiar with the subject matter at hand.

------
steventhedev
Are those dosages a fair comparison (ibuprofen 600x3, celecoxib 100x2, and
naproxen 375x2 daily)? Do they each provide the same level of pain reduction?

If not, there is literally no way to compensate for that level of statistical
bias. Stomach/kidney/heart damage is not linear, and there's no mention of
when people gave up taking the medications.

For someone who actually wants to read the study, here's the link:
[http://www.nejm.org/doi/full/10.1056/NEJMoa1611593#t=article](http://www.nejm.org/doi/full/10.1056/NEJMoa1611593#t=article)

tl;dr - they admit that taking more than 200mg of celecoxib does some damage,
and 800mg doses (they apparently were limited by regulations to 200mg/day)
showed the same heart damage they expected to see. Time magazine is a horrible
source

~~~
surak
I've done both Ibuprofen 400x3 and naproxen 500x2 daily for knee problems, and
would say the pain reduction from Ibuprofen is much greater than Naproxen. So
much so, that I would say its not a fair comparison, particularly at 600x3.

~~~
taude
I have to switch between multiple anti-inflammatories as my body seems to
adapt to what I take to manage chronic arthritic pain

~~~
rando444
Just as a suggestion, you might want to try going the other route and working
with your body instead of fighting it.

Have you looked into prolotherapy before? (sugar water injections)

[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2831229/](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2831229/)

~~~
zymhan
Yes because my body has such a hard time making sugar water

\s

~~~
Yxven
I'm not as skeptical of prolotherapy.

The idea is that it acts as an irritant which increases blood flow and other
healing responses to that area. Tendons in particular are thought to heal
slowly because they don't have great blood flow. This strikes me as similar to
the ideas of dry-needling and platelet-rich plasma injections.

------
gnicholas
The study authors made clear (in another article [1]) that they are not trying
to discourage people from infrequent ibuprofen/naproxen use. This study was
about prescription doses and daily use.

> "I don't want the public to think that if you take an occasional ibuprofen
> or naproxen that you're going to have kidney failure or you're going to
> die," Nissen says. "We didn't study that. We studied daily doses in
> arthritis patients [taking] ... high doses of these drugs."

The headline doesn't reflect this, but it probably wouldn't get as many clicks
if it said "daily use of prescription-level ibuprofen may not be as safe as
was thought".

1: [http://www.npr.org/sections/health-
shots/2016/11/13/50103343...](http://www.npr.org/sections/health-
shots/2016/11/13/501033431/safety-of-painkiller-celebrex-affirmed-in-new-
study)

------
readhn
here is input from my pharmacist friend on this article:

"Just saw this study come out a few days ago and it kind of is no news. The
harm of nsaids has been known and the warnings are out there. I tell patients
everyday not to take advil/naproxen if they are older than 40/50 because of
the heart and stomach issues.

Will be interesting once they release celebrex as over the counter, this
latest study will definitely catapult that process exponentially.

In the mean time, only take nsaids if u really need to, with food and i tell
patients to eat frequently and not too much salt to combat the water retention
which causes the heart issues."

~~~
emodendroket
Isn't aspirin regularly promoted as being _good_ for your heart?

~~~
Herodotus38
It is, as well as prevention of stroke and prevention of colon cancer. While
in the same general category of NSAIDs, you should think of it as really being
a different animal. It has more of an antiplatelet effect than the other
NSAIDs these articles are talking about which lead to decreased clotting.

~~~
soundwave106
Correct. Promoting aspirin as "good for the heart" is too generic of a phrase;
such generalization may lead to healthy people unnecessarily taking a daily
aspirin just because it is "good for the heart".

Aspirin is prescribed for some specific conditions due to its antiplatelet
effect. From what I understand, for normal healthy people, there isn't much
benefit of daily aspirin. And, there is potential for some side effects -- in
addition to the same stomach problems / heartburn issues that plague other
NSAIDS also has some bleeding type issues due to the antiplatelet effect.

~~~
emodendroket
> Correct. Promoting aspirin as "good for the heart" is too generic of a
> phrase; such generalization may lead to healthy people unnecessarily taking
> a daily aspirin just because it is "good for the heart".

Well, Bayer runs (or ran) ads encouraging just that behavior.

~~~
cgvgffyv
> Well, Bayer runs (or ran) ads encouraging just that behaviour.

Such a thing would never fly in Europe. They'd get laughed out of the room and
sued.

~~~
emodendroket
Be that as it may, their German scruples didn't stop them from running a huge
ad campaign in the US to this effect.

------
stinos
> people were assigned standard doses of 100mg celecoxib twice a day, 600mg
> ibuprofen three times a day, and naproxen 375mg twice a day

> In almost every measure, ibuprofen looks worse, naproxen is intermediate and
> celecoxib is the best.

> the heart concerns led the FDA to require its maker, Pfizer, to pay for
> additional studies to ensure that celecoxib did not put people at increased
> risk of heart trouble

And afaik Celecoxib is the only one marketed solely by Pfizer, at prices 5
times higher than the other 2.

Am I being paranoid thinking this at least deserves more study, not conducted
or paid for by pharma?

~~~
MichaelBurge
> Am I being paranoid thinking this at least deserves more study, not
> conducted or paid for by pharma?

Do their rivals have an incentive to check Pfizer's work? If they're
publishing bogus studies to get through regulatory checks, it could delay the
new drug from being released.

Further, if they're publishing bogus studies, it seems like the FDA would be
partially responsible. So one might expect the FDA to possibly run trials of
their own on a random sample of drugs, and compare with what the drug
companies published.

Also, Trump has mentioned speeding drugs through the FDA process. There might
be less incentive to cheat the results if they don't need to do it to release
their drug.

~~~
kqr
The FDA has these funny rules where you only need one successful study to be
accepted. So as long as you can pay for study after study you can just wait
until chance works out in your favor and you're out on the market. This is
known. FDA does not care.

------
zihotki
I would also like to add that not all Ibuprofen pills are equal. Biological
availability should be taken into account too. 400mg pills with 90% of
availability will have the same effect for pain as 600mg pills with 60% of
availability. But they'd likely have different effects on stomach/kidney.

~~~
e40
Is this quality listed somewhere? I've never heard of it.

~~~
zentiggr
The wikipedia template for these drug descriptions include basic
bioavailability / excretory data. Would still need to dig a bit for
comparative BA figures for tablets/caplets/liquids/etc, but at least the core
number is there.

------
chmaynard
This TIME headline seems totally disconnected from the article, which is about
COX-2 inhibitors.

~~~
gcp
Hmm? One of the main results relevant to the wider audience is surely that
Ibuprofen no longer looks like the most-recommendable drug because it looks
less safe than the alternatives. (Even if some remarks can be made towards the
study, that doesn't change the above in terms of presentation and relevance to
the audience)

~~~
chmaynard
From the paper:

At moderate doses, celecoxib was found to be noninferior to ibuprofen or
naproxen with regard to cardiovascular safety. (Funded by Pfizer;
ClinicalTrials.gov number, NCT00346216.)

[http://www.nejm.org/doi/full/10.1056/NEJMoa1611593](http://www.nejm.org/doi/full/10.1056/NEJMoa1611593)

The paper draws no conclusions about the relative safety of ibuprofen. The
only claim is that celecoxib is not inferior to the other two NSAIDs.

Note that this research study was funded by Pfizer, the company that markets
Celebrex.

~~~
gcp
Right, so this mentions ibuprofen explicitly, and it talks about
cyclooxygenase-2 selective inhibitors too. I still don't get what your
complaint about TIME's title is?

Did you think they should've mentioned celecoxib? That's much less known drug.
Mentioning ibuprofen means it's more likely to reach the audience that should
care about the study.

~~~
chmaynard
Yes, but we don't know whether Pfizer is hiding other similar studies that
came to different conclusions. This is a general problem with big pharma
research disclosure, not just Pfizer.

FYI, celecoxib is the generic name for Celebrex.

------
helthanatos
One major problem with studying medication effects is that to study humans,
not only does the experiment introduce more bias by studying different people,
it also leads to results that may contradict the next study. I wish there was
a more accurate way of measuring a drug's weaknesses, but it seems that these
human studies are here to stay a while.

~~~
SocratesV
Maybe we should aim to create within the next century a near perfect
simulation of us and our world, run it at an incredibly high speed and see if
any knowledge regarding this, and many other things, emerges. ;-)

------
mindcrime
All I can say about this is the following: I used to take a lot of vitamin I
(ibuprofen). I've had some knee issues resulting in chronic pain dating back
to my teens, and I always used Ibuprofen. And, yes, to be honest, at times I
took more than the recommended (OTC) dose, and took it for longer periods of
time than you're supposed to.

Then I noticed that they changed the warning labels to point out the increased
risk of heart attack from regular use of Ibuprofen.

Then I had a heart attack.

And all of my doctors (GP, cardiologist, etc.) suggested I quit taking
Ibuprofen.

Hrrmmm... to be fair, in the case of any individual, they can never _really_
say exactly why you had an MI when and where you did. And I was a little
overweight at the time, but I had very few other risk factors. I never smoked,
had no family history of early heart attacks, and I was only 41.

So did Ibuprofen play a role? We'll never know, but I'm following my doctor's
advice and not taking it anymore. I'd recommend anyone who uses Ibuprofen
frequently consider having a chat with their doctor and think hard about the
various risk factors involved.

------
a_plastic_bag
tl;dr: Celecoxib is safer than previously thought for people with heart
problems.

~~~
KaiserPro
causes the same level of heart problems as ibuprofen, but less kidney and GI
problems

------
CiPHPerCoder
WARNING: Autoplay video.

Even if you open it in a new tab and are still viewing the current one (middle
click on my computer).

------
OldSchoolJohnny
Who in the world doesn't know that NSAIDS are dangerous drugs at this point?
It's not exactly a surprise is it, this info has been around for years.
Acetaminophen is obviously much worse but still...

~~~
Broken_Hippo
There are folks that don't realize that acetaminophen or ibuprofen are in many
cough and cold formulations.

But they aren't really dangerous per se. Certain population groups shouldn't
take them, some can't tolerate them, and there are consequences to taking them
over a long-course (which is what this was comparing). But for most with
everyday aches, pains, colds, and so on, they aren't that dangerous.

You know, use responsibly and stuff.

------
pault
A friend's sister took a few ibuprofen a few days ago on an empty stomach,
started throwing up blood for several hours, spent the night in the ER. Now
she has an ulcer.

Edit: Ulcer, not hernia.

~~~
lightbyte
The warning label on every bottle of ibuprofen specifically says to not take
it on an empty stomach for exactly that reason. What was she expecting?

~~~
pault
I know; she's an idiot. I'm not sure many people know how dangerous this can
be, though. I'm not sure people take warnings on medication as seriously as
they should.

------
KaiserPro
Urgh, medical reporting is almost as bad as Tech reporting. No critical
thinking.

this is the gist: "There is a new drug that acts similarly to ibuprofen, but
appears to be less aggressive towards kidneys. Equally as bad for the heart."

However 70% of the participants failed to complete the study, so its not long
term. No percentage risks are quoted. It also doesn't compare how effective
celecoxib is compared to the much cheaper and well understood(interaction
wise) ibuprofen.

It also notes that high doses were not tested: "600mg ibuprofen three times a
day"

That my friend is a fucking large dose, as in three weeks and you have an
ulcer dose.

~~~
Broken_Hippo
Actually, that isn't that large of a dose.

The normal tablest in the US are 200mg: Lots of folks take 2 a few times a
day: 400mg 3 times a day, as recommended on most of the packaging.

Prescription ibuprofen is 800mg tablets (most times). This is a fairly common
dosage, 3-4 times a day.

~~~
claudius
Really?! Is this among the elderly who already have lots of little aches here
and there or the general population? When I broke my arm I took 400mg about
six or seven times over three days and for a cold I tend to take one or two
paracetamol, but taking pain killers regularly sounds very absurd to me and I
don’t know of anyone who takes anything stronger than coffee regularly and
more than once a month.

~~~
Broken_Hippo
Everything is in general: I might have worked in a pharmacy, but I'm not a
pharmacist or a doctor.

But I know a lot of folks will take ibuprofen for 7-10 days at those rates. It
is pretty common, and just as common for people to regularly take naproxen a
few times a day for chronic pain.

Taking pain killers regularly sounds absurd to you because you don't have that
sort of chronic pain. And pain is a funny thing: My mother openly admitted
that she would get to a point with migraines where the pain was so bad, the
side effects didn't quite seem to matter (She learned to go to the hospital or
doctor before then).

More often, however, these pain killers are the very things that makes every
day life bearable. Some people it means they can be more active but others it
just means they can open doors and grab toilet paper with less pain.

Your method is great for people that have occasional pain or needs: After all,
it seems a bit silly to take it for no actual reason. And as far as the folks
you know, well, if you are young that is more likely. And if not, it is just
something the people you know don't talk about.

