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Shelf Life of Medicine:
Drug Tests Conducted for the U.S. Military

The following brief summaries are for fair use and educational purposes only.
This is not medical advice.



A Consumer Reports Article and a Wall Street Journal Article can be read at the following link. Both articles contain information about some shelf life tests that were conducted on a variety of different medications at the request of the United States Military.

http://www.timestriponline.com/shelflife/drugexpiraton.htm

Following is a very brief summary of some of the information from the two articles at the above web site:

"In the area of consumer protection, there are drugs which may have a detrimental effect if taken after the expiration date. These are generally nitroglycerin, insulin, tetracycline, liquid antibiotics and oil capsules (such as fish oil). Never take these drugs after the expiration date.

"The U.S. military conducted one of the largest potency studies ever in the 1980s. It found that 90% of the drugs it tested (they were actually tested by the U.S. Food and Drug Administration) were safe and effective 15 years after their expiration dates.

"Bayer AG, the manufacturer of Bayer Aspirin, has a 2 year expiration date on all its aspirin. However, Bayer has tested its aspirin and found that even at 4 years it retained 100% of its potency. An independent study tested it at 5 years and still found a potency of 100%. So why the two year expiration date? Chris Allen, a vice president for the division that makes Bayer Aspirin states that Bayer's expiration dates are "pretty conservative". He stated that the expiration date is dictated by Bayer's packaging changes every few years.

"Francis Flaherty, a past pharmacist at the FDA states that "Manufacturers put expiration dates on for marketing, rather than scientific, reasons. It's not profitable for them to have products on a shelf for 10 years. They want turnover."

"Joel Davis, a former FDA expiration-date compliance chief, says 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 says. "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."

"Only one report known to the medical community linked an old drug to human toxicity. A 1963 Journal of the American Medical Association article said degraded tetracycline caused kidney damage. Even this study, though, has been challenged by other scientists. Mr. Flaherty says the Shelf Life program encountered no toxicity with tetracycline and typically found batches effective for more than two years beyond their expiration dates.

"A very few drugs aren't retested. The military has found that water-purification tablets and mefloquine hydrochloride, for malaria, routinely fail stability testing beyond their expiration dates, so it has removed them from the program."



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