Do Medicines Really Expire?

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 labellings. 

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 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."

 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."

 

By Richard Altschuler