Does Medication Really 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 2006,” and it is August 2009, 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?

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. 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 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.”

Here is my advice: if you have anything in capsule form, discard it after its expiration date as capsules are not airtight and oxygen is the key factor in rendering drugs unusable. If you have tablet forms, keep the drugs as they are compressed and no oxygen damage can be done other than a very slow natural degredation. Your savings could be significant, and you won’t have to make an ER visit for that prescription you know always treats your condition.


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About Larrian
Larrian Gillespie is a gynecologic urologist who received her medical degree from the University of California at Los Angeles School of Medicine and practiced Urology and Urogynecology in Beverly Hills for 15 years before retiring.With an ability to translate “doctor speak” into terms anyone can understand, Larrian has been featured in over 75 magazine stories and numerous television shows, including Good Morning America, CBS Woman to Woman News, and CNN. She has served on the medical advisory board of SHAPE Magazine, Prevention Books, Readers Digest Books,Oxmoor Books, Low Carb Energy and been a frequent source for numerous other publications, including WebMD.

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