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Do Medications Really Expire?
By Richard Altschuler
http://www.rense.com/general29/fom.htm
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" four
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 two 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 cocktails and hot tub dip (we were
in "Leisure World," near Laguna Beach, CA, 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 et al., in the Journal
of the American Medical Association, JAMA,
184:111, 1963). 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 U.S. 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 two to three years, so it began a testing program
to see if it could extend the life of its inventory.
The testing, conducted by the U.S. Food and Drug
Administration, 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 two-year or three-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
four-year-old aspirin, it remained 100% effective, he
said. So why doesn't Bayer set a four-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 four-year life would be
impractical. Bayer has never tested aspirin beyond
four 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 five 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."
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