This was circulated earler, but still may be of interest to many.
DO
MEDICATIONS
REALLY
EXPIRE
?
By Richard Altschuler*
** *
**
A
FAMILY
OF
DOCTORS
IN
ENGLAND
&
IN
MUMBAI
HAVE
BEEN HAMMERING
THIS
POINT
THAT
MEDICINES
DON’T
EXPIRE.
*
*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 labelling. 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.*
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.
One of the largest studies ever conducted that supports the above points
about "expired drug" labelling 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, about 90% of them were safe and effective as far as 15
years past their 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 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." 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** labelling**."*
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