Skip to comments.Do medications really expire?
Posted on 10/09/2002 8:58:38 PM PDT by Constitutionalist Conservative
September 9, 2002
Try An Experiment With Your Mother-In-Law
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 doesnt mean anything," when I pointed out that the Tylenol she was about to take had "expired" four 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 two 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, CA, 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:
One of the largest studies ever conducted that supports the above points about "expired drug" labeling was done by the U.S. 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 two to three years, so it began a testing program to see if it could extend the life of its inventory. The testing, conducted by the U.S. Food and Drug Administration, 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 doesnt 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. "Its not profitable for them to have products on a shelf for 10 years. They want turnover."
The FDA cautioned there isnt 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 its in the refrigerator." Consider aspirin. Bayer AG puts two-year or three-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 four-year-old aspirin, it remained 100% effective, he said. So why doesn't Bayer set a four-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 four-year life would be impractical. Bayer has never tested aspirin beyond four years, Mr. Allen said. But Jens Carstensen has. Dr. Carstensen, professor emeritus at the University of Wisconsins pharmacy school, who wrote what is considered the main text on drug stability, said, "I did a study of different aspirins, and after five 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 Ill take a swig of the 10-year dead package of Alka Seltzer in my medicine chest - to ease the nausea Im 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 industrys "expiration date labeling."
So, heigh-ho, every 2 weeks I make a 30-mile (one-way) drive to the only compounding pharmacy around to buy him a new $50 bottle of Cipro suspension.
Just learned from my (human) doctor that a similar suspension is now offered by non-compounding pharmacies. Unfortunately it is cherry-flavored, and the vet and I are unsure as to how the Cat will "tolerate" (i.e., not up-chuck) the cherry sort. We plan to give it a try.