It’s expired – but does that mean it’s not good?

It’s expired – but does that mean it’s not good?
by Anthony Roberts

One of the most common questions I hear in both the steroid-world as well as the nutritional industry is “my stuff expired, is it still safe to use?” This ranges from Winstrol to protein powder and I can’t count how many times I’ve been asked this. Personally, I tend to be on the liberal side with my own stuff, often going pretty far past an expiry date. But what actually happens to drugs when they go past their expiration date? If your aspirin has expired, will it still get rid of your headache? (Answer: Wisconsin’s pharmacy school tested aspirin 4 years after it was made, and found that it was still 100% potent) But are you going to die because you’ve been using protein powder that expired yesterday?

The Wall Street Journal contends that the United States Military routinely has the FDA retest drugs that have expired, to insure potency and safety, after which they are issued new expiration dates: “In the U.S. military, expired drugs are routinely left on the shelf after FDA testing shows they are still safe and effective.” So while I don’t want to simply tell people to use and eat whatever they want, from whenever it expired, I can tell you that supposedly expired drugs are routinely checked, found to be good, and stamped with a new expiration date by none other than the Food and Drug Administration. Use common sense, if it’s supposed to be milk and it looks like cottage cheese but smells like sour cream, then ditch it.

But if I’ve got an unopened bottle of testosterone, and it’s past expiration, you’re going to have a hard time getting me to ditch it. I’ve used various stimulants that were past their expiration, and even liquicaps that had solidified, and they still produced all of the same CNS stimulation that I had gotten before they had expired. I even took a few shots of GHRP-6, about a month after I had first reconstituted it (it’s supposed to “die” within a couple of weeks after reconstitution)…and I got literally all of the same effects in the same amount of time (if you’ve ever used it, you know that you get a crazy appetite increase from your blood sugar dropping and your ghrelin being elevated, within an hour of taking it). I’m not telling you what to do with expired products, but I can tell you my experience with them…they’ve always retained potency and I’ve had no adverse effects from them. I know for a fact that most nutritional companies just throw a standard expiration date on their products, with no idea if they’re still good after the date. Usually, they put the same time-period on them as other companies, with no idea as to why they’re using it.

In fact, I’m sitting here looking at a bottle of water, and guess what? It’s got a f*cking expiration date on it. What the f*ck is going to happen to my water when it expires?

Here’s a great article on the topic of medication and whether or not it actually expires:

Do Medications Really Expire
By Richard Altschuler9-9-2

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?

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:

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. A contested example of a rare exception is a case of renal tubular damage purportedly caused by expired tetracycline (reported by G. W. Frimpter et al., in the Journal of the American Medical Association, JAMA, 184:111, 1963). This outcome (disputed by other scientists) was supposedly caused by a chemical transformation of the active ingredient. Third, 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, in accordance with the cliché, “better safe than sorry.” 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. 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 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, especially if it’s 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 Wisconsin’s 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 I’ll take a swig of the 10-year dead package of Alka Seltzer in my medicine chest – to ease the nausea I’m 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 industry’s “expiration date labeling.”

Here’s another article, as found in the Wall Street Journal, on expiration dates:

Poor Nations Spurn Free Drugs If Too Close to Expiration Date

In the U.S. military, expired drugs are routinely left on the shelf after FDA testing shows they are still safe and effective. Meanwhile, charitable groups and developing nations often reject drug-company donations of much-needed medications that are nearing their expiration dates. Why the incongruity? The World Health Organization in 1996 urged countries to refuse free drugs that didn’t have at least a year left before expiration. WHO said there had been many “inappropriate donations.” The $55 million in drugs contributed to Armenia after a 1988 earthquake was the “wake-up call to the donor world,” says Jonathan Quick, an official of WHO. Many had already expired, according to WHO. The issue grew hotter in 1997, when the New England Journal of Medicine reported that at least half of the drugs donated during the war in Bosnia were unusable, in most cases because they had reached their expiration dates. The article said the effort “may have been used to dump outdated supplies” to gain tax breaks and avoid millions of dollars of disposal costs.
Turned Away

Reflecting the new militancy on the issue, officials in Haiti, Kenya, Egypt and Peru in 1998 refused more than two million cartons of antibiotics and pain relievers because were due to expire within a year. The same year, the Catholic Medical Mission Board turned away $32.4 million in drugs because some had only eight months to a year left before expiration. Yet most drugs the Food and Drug Administration retests for the U.S. military prove safe and potent long past their expiration dates. And even Philippe Autier, a doctor who was an author of the New England Journal article, says he has used expired antibiotics in the Honduran jungle. “We know that most expired drugs will pose no danger, so when we have no other choice, we use them,” he says. Asked why drugs with less than one year to expiration are shunned by international medical groups, Robin Gray, a WHO medical officer, says that recipients of donations deserve the same protections as U.S. citizens.

If expired drugs weren’t potentially harmful, he reasons, the FDA wouldn’t require expiration dates. He says he wasn’t aware of the FDA retesting and extending of drugs for the military. Some see a political agenda lurking in the issue. “This is an anti-pharmaceutical-industry, anti-U.S.-motivated attack,” contends Glenna Crooks, a former Reagan administration health-policy adviser who is a consultant to several drug companies. “Are we destroying drugs that could be used? Yes,” she says. To the suspicion that companies donate short-dated drugs to get tax deductions and save disposal costs, the companies respond that they also can get deductions for destroying drugs. But the deductions aren’t as large. Civilian Effort Some U.S. pharmaceutical companies and aid organizations, regarding the WHO guidelines as too restrictive, banded together in 1997 to work with WHO on revising them. Their Partnership for Quality Medical Donations eventually endorsed the guidelines after WHO changed them last year to allow for occasional exceptions to its one-year rule.

The FDA’s Shelf Life Extension Program for the military has been used once on drugs for a civilian relief effort. With medicine critically scarce in Russia after the Soviet system collapsed, the FDA tested expired batches of an intravenous solution for dehydration called Lactated Ringers, extending its shelf life before it was sent abroad by Project Hope. Jack Bode, an official of the Millwood, Va.,-based relief group, says that in the current environment, the shipping of expired drugs, even those whose dates had been extended by the FDA, “wouldn’t happen again.” Yet Mr. Bode, who has spent the past eight years working with refugees in Somalia, Rwanda and elsewhere, has this observation: “Has anyone been harmed by expired drugs? Maybe. But I can definitively tell you that a lot of people died because they didn’t get expired drugs.”