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EXPIRATION DATES ON MEDS

Friday, March 25, 2011

BEFORE YOU GO AND CLEAN OUT THE MEDICINE CABINET THIS SPRING READ THIS!


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. 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.

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. Wisdom dictates that
if your life does depend on a drug, and you must have 100% of its original
strength, you should probably toss it and get a refill. 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, both 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
manufacturerstypically 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 he retired 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." 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. Doctor Jens Carstensen has.
Dr. Carstensen, professor emeritus at the University of Wisconsin's pharmacy
school, wrote what is considered the main text on drug stability, and said, "I
did a study of different aspirins, and after 5 years, Bayer was still excellent.
Aspirin, if made correctly, is very stable."



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  Member Comments About This Blog Post:

TERESAMARIE1959 3/25/2011 9:09PM

    I don't usually worry about the pills, I am more careful about watching expiration dates on liquids and eyedrops, creams etc. They just seem more fragile and easier to contaminate to me.

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HELEN_BRU 3/25/2011 4:16PM

    Ha! I've just thrown out some aspirin that was over the expiry date. Thanks for the info., Joan!



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