Do Medicines Really Expire Or Are We Being Taken For A Ride?

By Richard AITSCHULER

Does the expiration date on a bottle of  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" a little over four years 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 half an hour later she reported the pain seemed to have eased 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.

On my return to New York and high-speed Internet 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" was done by the US military nearly 18 years ago, according to a feature story inThe 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 programme 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 even 15 years past their expiration date.

In the light of these results, a former director of the testing programme, 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 programme, which is weighted towards drugs used during combat, to conclude most drugs in consumers' medicine cabinets are potent beyond the expiration date. 

However, Joel Davis, 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 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. 

But Chris Allen, a vice-president at the Bayer unit that makes aspirin, said the dating is "pretty conservative"; when Bayer had 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 programmes," 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 (US) 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.

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.

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