By Richard 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.
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. 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, ” 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.
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. ”