Expiring medicines

[Guest guest]

Manish Kothari sends this interesting mail:

DO MEDICATIONS REALLY EXPIRE?

Try An Experiment With Your Mother-In-Law

By 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.

, 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, , 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.

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. 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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