from an email;
DO MEDICATIONS REALLY EXPIRE?
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
cocktails 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."
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