Some – expired – medicine OK, tests say – The Blade, Is Expired Viagra Safe To Take.

With a migraine headache threatening, reach for Imitrex, the prescription drug that brings these debilitating headaches to a screeching halt. \\The pharmacy label warns: “Discard after February 2005.” Those tiny tablets cost $16 each, almost their weight in gold.

Can you still take it in June?

Ask the same questions for scores of other prescription drugs, which cost people in the United States more than $160 billion annually.

The expiration dates on jugs of milk and cartons of yogurt tell consumers when a product goes bad. That may not always be true with prescription drug labels, according to research.

Government tests have found that some drugs stay fresh for years longer, enabling the military to save millions of dollars in replacing “expired” drugs.

While the American Medical Association has urged the pharmaceutical industry to see if consumers are wasting money by discarding drugs that are still safe and effective, nothing has been done.

The research raises questions about how seriously consumers should take expiration dates on some medicines, but leaves them without key information to make decisions, said Stephen R. Byrn. He is an expert on drug stability at Purdue University.

“A consumer really needs to know what they are doing to take a drug that has expired,” Mr. Byrn said. “In most cases the data to support using drugs past their expiration date is not available, so, of course, consumers would not be able to get this information.”

In dispensing pills, pharmacists use the manufacturer’s expiration date to pick the “discard after” or “beyond-use” date they put on prescription labels. It can’t exceed the manufacturer’s expiration date, and usually is shorter. If the manufacturer says Prozac, Viagra, Cipro, Ambien, or Valium expires in May, 2006, patients might get a prescription bottle labeled “Discard After May, 2005.”

The Shelf Life Extension Program, however, has found that drugs can stay safe and effective long after the manufacturer’s expiration date if properly stored in the original container. Run by the U.S. Food and Drug Administration for the U.S. Department of Defense, it has saved the military millions of dollars on replacement of “expired” drugs.

“This program is a large cost saver to the taxpayer,” said Ellen Kavanagh, an assistant manager of the Shelf Life Extension Program. In one instance, The Defense Department spent about $350,000 on testing of supposedly expired drugs, and avoided needlessly discarding about $33 million worth of medicine.

Robbe C. Lyon, deputy director of product quality research at the FDA, said consumers should pay attention to expiration dates on drug bottles because shelf-life program’s findings apply to drugs stored in the original containers under ideal conditions.

“But once the container is opened and exposed to an unpredictable environment it is difficult to predict the drug’s effectiveness,” Mr. Lyon said. “For patients who rely on medications to stay alive, like heart medications, expired drugs can be dangerous because they may not be getting the full effectiveness of the drug.”

Other studies, however, suggest some prescription drugs in the bottles given to patients, stored under ordinary household conditions, are surprisingly durable. They may remain fresh beyond the “discard after” date.

The Medical Letter, a respected source of independent information about drugs, covered the topic in a 2002 article. It reported that certain medicines, stored in high humidity and other bad conditions, stayed good to use for 1.5 to 9 years after their expiration dates. For instance, Symmetrel (amantadine) and Flumadine (rimantidine), anti-viral drugs used to prevent and treat influenza, withstood 160-degree temperatures and were good after the equivalent of 25 years of ordinary storage.

“Many drugs stored under reasonable conditions retain 90 percent of their potency for at least 5 years after the expiration date on the label, and sometimes much longer,” the report stated.

Nobody knows for sure, because a consumer-oriented version of the Shelf Life Extension Program – which would check the actual lifespan of prescription drugs stored in bathrooms, kitchens, purses, and cars – has never been done.

“Currently, I am not aware of any programs that focus on drug stability in the consumer environment,” said Claudia Okeke, an associate director at the U.S. Pharmacopeia in Rockville, Md. The nonprofit private group establishes standards for stability, purity, and quality of medicines and is the source of the USP symbol found on medications.

Overly conservative expiration and discard-after dates could make consumers waste money by throwing away good drugs. On the other hand, taking stale medicine that doesn’t work could make diseases get worse.

Contrary to common belief, there is little scientific evidence that expired drugs are toxic.

The Medical Letter could find just one reported case in which a patient may have been harmed by taking an expired drug. It occurred more than 40 years ago and involved a patient who may have suffered kidney damage from taking expired tetracycline, an antibiotic. Since then, tetracycline products have been changed to eliminate the problem.

With doctors confused about what to advise patients, the AMA in 2001 urged that the pharmaceutical industry study the medical and financial implications of expiration dating.

“The actual shelf life of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container, which could result in unnecessary waste, higher pharmaceutical costs, and possibly reduced access to necessary drugs for some patients,” the AMA’s Council on Scientific Affairs said.

One group of patients would benefit most by lengthening expiration dates.

They use medication prescribed on a “take-as-needed” basis. Patients take a pill only when symptoms appear, or get worse, and pills may sit unused for months at a time. Such drugs include pain medicines; migraine drugs like Imitrex; sleeping aids like the best-seller, Ambien; male impotence drugs like Viagra, Levitra, and Cialis; allergy drugs; some anti-anxiety drugs; and anti-viral medicines intended for use only if influenza outbreaks occur.

Nitroglycerin, the heart drug, is one take-as-needed drug known to have a very short shelf life after the bottle is unsealed. Liquid medicines also have short shelf lives.

Other patients also may switch from one medicine to another and then back to the original drug, or take medication breaks that leave pills sitting unused.

There are wider implications, as well, since some international aid agencies and foreign countries refuse donations of desperately needed drugs for AIDS and other serious diseases if the medication is expired or nearing the expiration date.

AMA called on the pharmaceutical industry, including the Pharmaceutical Research and Manufacturers of America, to determine whether extending expiration dates would save money and involve any risks.

“A letter was sent to PhRMA simply urging them to share the Council on Scientific Affairs report with its member companies to determine whether longer expiration dates would provide any economic or clinical benefits for patients,” the council’s Nancy Nolan said. The AMA got no answer, she added.

Alan Goldhammer, a vice president for regulatory affairs at PhRMA, said he could not determine if the association carried through on the recommendation. He disputed any implication that the industry uses conservative expiration dating to increase sales by making consumers discard good medicine.

Although health insurers spend heavily on prescription drug benefits, they have not joined the AMA in urging such a program. Spokesmen for Aetna and Wellpoint did not even respond to requests for comment.

Robert Weber, chairman of pharmacy and therapeutics at the University of Pittsburgh school of pharmacy and executive director of pharmacy and therapeutics at the University of Pittsburgh Medical Center, said savings could be significant.

“The kind of research suggested by the AMA should be done and could save consumers and insurers money, considering the high cost of prescription drugs,” he said. “Putting the results into effect, however, might take a lot ofconsumer education to avoid situations like hoarding drugs andusing medications that are no longer necessary for them.”

Contact Michael Woods at: mwoods@nationalpress.com.

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