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1 27th July 18:39
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Default Article - Do Medications Really Expire? (aspirin renal hay fever headache tetracycline)


Posted for informational purposes only....

=================
Do Medications Really Expire?

from Medscape General Medicine™
Posted 08/21/2003

Thomas A. M. Kramer, MD

This month's Psychopharmacology Today column will be our second guest column. It
is a piece that has been available on the Web for about a year but was brought
to my attention recently. It answers a question that I have asked and been asked
multiple times. Before I found this, no one had ever given me a straight answer
about what the expiration dates on medications mean and how seriously they
should be taken. This is an important issue, and I think that
psychopharmacologists, if not all practitioners and patients, will find this


September 9, 2002
DO MEDICATIONS REALLY EXPIRE?
Try An Experiment With Your Mother-In-Law

By Richard Altschuler

Does the expiration date on a bottle of a medication mean anything? If a bottle
of Tylenol, for example, says something like "Do not use after June 1998," and
it is August 2002, should you take the Tylenol? Should you discard it? Can you
get hurt if you take it? Will it simply have lost its potency and do you no
good?

In other words, are drug manufacturers being honest with us when they put an
expiration date on their medications, or is the practice of dating just another
drug industry scam, to get us to buy new medications when the old ones that
purportedly have "expired" are still perfectly good?

These are the pressing questions I investigated after my mother-in-law recently
said to me, "It doesn't mean anything," when I pointed out that the Tylenol she
was about to take had "expired" 4 years and a few months ago. I was a bit
mocking in my pronouncement -- feeling superior that I had noticed the chemical
corpse in her cabinet -- but she was equally adamant in her reply, and is
generally very sage about medical issues.

So I gave her a glass of water with the purportedly "dead" drug, of which she
took 2 capsules for a pain in the upper back. About a half hour later she
reported the pain seemed to have eased up a bit. I said "You could be having a
placebo effect," not wanting to simply concede she was right about the drug, and
also not actually knowing what I was talking about. I was just happy to hear
that her pain had eased, even before we had our evening ****tails and hot tub
dip (we were in "Leisure World," near Laguna Beach, California, where the hot
tub is bigger than most Manhattan apartments, and "Heaven," as generally
portrayed, would be raucous by comparison).

Upon my return to NYC and high-speed connection, I immediately scoured the
medical databases and general literature for the answer to my question about
drug expiration labeling. And voila, no sooner than I could say "Screwed again
by the pharmaceutical industry," I had my answer. Here are the simple facts:

First, the expiration date, required by law in the United States, beginning in
1979, specifies only the date the manufacturer guarantees the full potency and
safety of the drug -- it does not mean how long the drug is actually "good" or
safe to use. Second, medical authorities uniformly say it is safe to take drugs
past their expiration date -- no matter how "expired" the drugs purportedly are.
Except for possibly the rarest of exceptions, you won't get hurt and you
certainly won't get killed. A contested example of a rare exception is a case of
renal tubular damage purportedly caused by expired tetracycline (reported by G.
W. Frimpter and colleagues in JAMA, 1963;184:111). This outcome (disputed by
other scientists) was supposedly caused by a chemical transformation of the
active ingredient. Third, studies show that expired drugs may lose some of their
potency over time, from as little as 5% or less to 50% or more (though usually
much less than the latter). Even 10 years after the "expiration date," most
drugs have a good deal of their original potency. So wisdom dictates that if
your life does depend on an expired drug, and you must have 100% or so of its
original strength, you should probably toss it and get a refill, in accordance
with the cliché, "better safe than sorry." If your life does not depend on an
expired drug -- such as that for headache, hay fever, or menstrual cramps --
take it and see what happens.

One of the largest studies ever conducted that supports the above points about
"expired drug" labeling was done by the US military 15 years ago, according to a
feature story in the Wall Street Journal (March 29, 2000), reported by Laurie P.
Cohen. The military was sitting on a $1 billion stockpile of drugs and facing
the daunting process of destroying and replacing its supply every 2 to 3 years,
so it began a testing program to see if it could extend the life of its
inventory. The testing, conducted by the US Food and Drug Administration (FDA),
ultimately covered more than 100 drugs, prescription and over-the-counter. The
results showed that about 90% of them were safe and effective as far as 15 years
past their original expiration date.

In light of these results, a former director of the testing program, Francis
Flaherty, said he concluded that expiration dates put on by manufacturers
typically have no bearing on whether a drug is usable for longer. Mr. Flaherty
noted that a drug maker is required to prove only that a drug is still good on
whatever expiration date the company chooses to set. The expiration date doesn't
mean, or even suggest, that the drug will stop being effective after that, nor
that it will become harmful. "Manufacturers put expiration dates on for
marketing, rather than scientific, reasons," said Mr. Flaherty, a pharmacist at
the FDA until his retirement in 1999. "It's not profitable for them to have
products on a shelf for 10 years. They want turnover."

The FDA cautioned there isn't enough evidence from the program, which is
weighted toward drugs used during combat, to conclude most drugs in consumers'
medicine cabinets are potent beyond the expiration date. Joel Davis, however, a
former FDA expiration-date compliance chief, said that with a handful of
exceptions -- notably nitroglycerin, insulin, and some liquid antibiotics --
most drugs are probably as durable as those the agency has tested for the
military. "Most drugs degrade very slowly," he said. "In all likelihood, you can
take a product you have at home and keep it for many years, especially if it's
in the refrigerator." Consider aspirin. Bayer AG puts 2-year or 3-year dates on
aspirin and says that it should be discarded after that. However, Chris Allen, a
vice president at the Bayer unit that makes aspirin, said the dating is "pretty
conservative"; when Bayer has tested 4-year-old aspirin, it remained 100%
effective, he said. So why doesn't Bayer set a 4-year expiration date? Because
the company often changes packaging, and it undertakes "continuous improvement
programs," Mr. Allen said. Each change triggers a need for more expiration-date
testing, and testing each time for a 4-year life would be impractical. Bayer has
never tested aspirin beyond 4 years, Mr. Allen said. But Jens Carstensen has.
Dr. Carstensen, professor emeritus at the University of Wisconsin's pharmacy
school, who wrote what is considered the main text on drug stability, said, "I
did a study of different aspirins, and after 5 years, Bayer was still excellent.
Aspirin, if made correctly, is very stable.

Okay, I concede. My mother-in-law was right, once again. And I was wrong, once
again, and with a wiseacre attitude to boot. Sorry mom. Now I think I'll take a
swig of the 10-year dead package of Alka Seltzer in my medicine chest -- to ease
the nausea I'm feeling from calculating how many billions of dollars the
pharmaceutical industry bilks out of unknowing consumers every year who discard
perfectly good drugs and buy new ones because they trust the industry's
"expiration date labeling."


Thomas A. M. Kramer, MD, Associate Professor of Psychiatry, University of
Chicago, Chicago, Illinois

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E l l i o t t

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2 28th July 10:42
liz
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Default Article - Do Medications Really Expire?


Interesting article.

Take care,
Liz

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3 28th July 10:42
tono
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Default Article - Do Medications Really Expire?


<snipped>

I often thought it was a scam. Especially when a girlfreind of mine
worked for McNeil Pharmacutical. They had a store for employees to buy
over the counter drugs at very, very low prices. Most of it was expired!

Tono

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