- 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
- 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."