Perhaps you’ve heard the cliche, "Aspirin could never get beyond the FDA
today." I suspect that aspirin would make it, though of course the point is
that the FDA can be overly restrictive. Given this restrictive climate, how
did Naproxen ("Alleve") get FDA approval? According to the pamphlet my doctor
gave me when prescribing Naproxen (I’m not a pharmacist, obviously), this
substance can be quite dangerous when too much is taken, or if it is taken
by someone who regularly drinks more than a few drinks daily- you may end up
with a severely damaged liver. Further, the enantiomer of Naproxen-
inseparable, as far as I know- is a liver toxin in relatively low doses.
I’m thinking of people like my grandmother, who used to take 16- 20 aspirin
per day to control arthritis pain. Just as aspirin is commonly abused in the
search to control pain, I’d be willing to bet that naproxen will meet the same
fate. With this in mind, together with its potential for toxic side- effects,
how did it ever get on the market? I’m truly baffled, and curious.
Regards
===================================================================
Eric J. Forbis forb0…@gold.tc.umn.edu
——————————————————————-
"Conscience, they tell us, is the creature of prejudice, but I know
from experience that conscience persists in following the order of
nature in spite of all the laws of man." _Emile_, Rousseau
===================================================================
In article <forb0004.231.00356…@gold.tc.umn.edu>,
Eric J. Forbis <forb0…@gold.tc.umn.edu> wrote:
>Perhaps you’ve heard the cliche, "Aspirin could never get beyond the FDA
>today." I suspect that aspirin would make it, though of course the point is
>that the FDA can be overly restrictive. Given this restrictive climate, how
>did Naproxen ("Alleve") get FDA approval?
I suspect its effectiveness in treating menstrual cramps along with its
extended duration of action in this indication went a long way towards
convincing the FDA advisory panel.
>According to the pamphlet my doctor
>gave me when prescribing Naproxen (I’m not a pharmacist, obviously), this
>substance can be quite dangerous when too much is taken, or if it is taken
>by someone who regularly drinks more than a few drinks daily- you may end up
>with a severely damaged liver. Further, the enantiomer of Naproxen-
>inseparable, as far as I know- is a liver toxin in relatively low doses.
True liver toxicity associated with the use of naproxen is very rare,
though it can elevate liver enzymes (usually without any other
symptoms) in some people, but I’ve _never_ heard of it having a
hepatotoxic enantiomer, and anyway, the drug sold as naproxen is the
dextro isomer–it’s not a racemic mixture. The warning against using
it in someone who drinks heavily is that its own GI irritant effects
might be additive or supra-additive to the GI irritant effects of
alcohol. Furthermore, preexisting liver damage (such as you might see
in cirrhosis) tends to cause more free naproxen to circulate unbound to
plasma proteins, making a given dose potentially more potent. Naproxen
has a relatively low acute toxicity; certainly less than aspirin or
acetaminophen.
The big risk in the use of a drug like naproxen is its propensity to
cause GI side effects and even ulcers at moderate to high doses, though
aspirin is undoubtedly worse in this regard. You wouldn’t expect to see
many cases in people following the OTC dosage recommendations. Drugs of
this class can also cause kidney damage when used in high doses for long
periods of time, and aggravate preexisting renal dysfunction.
>I’m thinking of people like my grandmother, who used to take 16- 20 aspirin
>per day to control arthritis pain. Just as aspirin is commonly abused in the
>search to control pain, I’d be willing to bet that naproxen will meet the same
>fate. With this in mind, together with its potential for toxic side- effects,
>how did it ever get on the market? I’m truly baffled, and curious.
Well, your grandmother would probably need to take a lot less Aleve;
it’s quite a bit more potent than aspirin for a given degree of anal-
gesia and antiinflammatory actions. The single OTC dose of Aleve is
lower than the Rx dose: 200mg versus 250mg of naproxen, and the total
recommended daily dose is lower: 600mg of naproxen per day. There
will be some people who ignore the dosage recommendations; that’s one
reason they lowered the OTC dose by 20% and specified a maximum daily
dose: to add in a margin of safety. When it comes down to it, I guess
they figured that more people would be helped than hurt by having it
available OTC. Time will tell. There doesn’t seem to have been a
public health disaster following the introduction of ibuprofen as an
OTC medication.
–
Steve Dyer
d…@ursa-major.spdcc.com
- Hide quoted text — Show quoted text -
In article <CsyvDw….@spdcc.com> d…@spdcc.com (Steve Dyer) writes:
>In article <forb0004.231.00356…@gold.tc.umn.edu>,
>Eric J. Forbis <forb0…@gold.tc.umn.edu> wrote:
>>Perhaps you’ve heard the cliche, "Aspirin could never get beyond the FDA
>>today." I suspect that aspirin would make it, though of course the point is
>>that the FDA can be overly restrictive. Given this restrictive climate, how
>>did Naproxen ("Alleve") get FDA approval?
>>I’m thinking of people like my grandmother, who used to take 16- 20 aspirin
>>per day to control arthritis pain. Just as aspirin is commonly abused in the
>>search to control pain, I’d be willing to bet that naproxen will meet the same
>>fate. With this in mind, together with its potential for toxic side- effects,
>>how did it ever get on the market? I’m truly baffled, and curious.
>Well, your grandmother would probably need to take a lot less Aleve;
>it’s quite a bit more potent than aspirin for a given degree of anal-
>gesia and antiinflammatory actions. The single OTC dose of Aleve is
>lower than the Rx dose: 200mg versus 250mg of naproxen, and the total
>recommended daily dose is lower: 600mg of naproxen per day. There
>will be some people who ignore the dosage recommendations; that’s one
>reason they lowered the OTC dose by 20% and specified a maximum daily
>dose: to add in a margin of safety. When it comes down to it, I guess
>they figured that more people would be helped than hurt by having it
>available OTC. Time will tell. There doesn’t seem to have been a
>public health disaster following the introduction of ibuprofen as an
>OTC medication.
Another pharmacist was kind enough to reply via email, and suggested that the
dire warnings attatched to my prescription Naproxen were more motivated by
‘CYA’ (cover ye arse) than a clear and present danger. As for it being more
potent than aspirin, I enthusiastically agree.
I’m curious: does naproxen inhibit platelet activity, so yielding similar
benefits as aspirin vis a vis heart attacks?
Regards,
===================================================================
Eric J. Forbis forb0…@gold.tc.umn.edu
——————————————————————-
"Conscience, they tell us, is the creature of prejudice, but I know
from experience that conscience persists in following the order of
nature in spite of all the laws of man." _Emile_, Rousseau
===================================================================
In article <forb0004.239.00214…@gold.tc.umn.edu>,
Eric J. Forbis <forb0…@gold.tc.umn.edu> wrote:
>I’m curious: does naproxen inhibit platelet activity, so yielding similar
>benefits as aspirin vis a vis heart attacks?
Naproxen is a reversible inhibitor of cyclooxygenase, so its effects
on platelet aggregation last only as long as it’s present in the
body. Aspirin is unique among the NSAIDs in that it irreversibly
acetylates platelet cyclooxygenase, knocking it out for the life
of the platelet.
–
Steve Dyer
d…@ursa-major.spdcc.com