Healthy Skepticism Library item: 7004

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Mitchell E.
Drugs' expiration dates in question
NEWSDAY 2006 Nov 30

Abstract:

We all know what to do when the milk goes sour or the meat takes on a greenish glow. We can smell it, we can see it; and the date stamped on the packaging clearly says it’s time to toss it out.

So why can we be less than diligent with the bottle of aspirin that’s languishing in the medicine cabinet or those few antibiotic pills we kept from last year?

Are they still safe to use?

The answer is … there is no clear-cut answer.

Many, including the pharmaceutical industry and researchers at the Food and Drug Administration, say it’s best not to take a chance, because an outdated medication might lose potency and no longer be helpful.

But others, including researchers who performed a study at the request of the Department of Defense, say 96 types of drugs that they tested remained safe and potent well beyond the expiration date.

The American Medical Association has suggested that the pharmaceutical industry should come up with substantive evidence to show why the expiration dates they stamp on their drugs should not be extended. The AMA also has said that if it’s shown that drugs do remain safe for a longer time, consumers could save by replacing medications less frequently.

Federal law has required pharmaceutical companies to place expiration dates on packaging since 1979. The manufacturer states that the drug will maintain its full potency up until that date, which ranges between
12 and 60 months, known as the drug’s “shelf life.”

A pharmacist, in turn, may open the container after it comes from the manufacturer and place it into a smaller bottle or vial for use by the customer. In that case another expiration date, known as the “beyond use” date, which does not exceed the manufacturer’s shelf life date, is put on the new container.

Pharmacists are not supposed to sell any medication beyond its expiration date.

In 1985, the Department of Defense, sitting with an expensive stockpile of typical drugs used by a consumer, asked the Food and Drug Administration to check the drugs for stability beyond their expiration date. The resultant study showed that 84 percent of 1,122 lots of drugs stored in military facilities in their unopened, original containers stayed stable for an average of 57 months beyond expiration date.

But Robbe C. Lyon, the FDA’s deputy director of product quality research, warned that those drugs were stored under ideal conditions, whereas an “unpredictable environment” in a consumer’s home might affect the drug’s stability.

“My advice,” he said, “would be to follow the expiration date on the label.” He also cautioned that in cases where patients rely on medications for such conditions as heart disease, an expired, less-potent drug could be dangerous.