Are We Still Being Lied To?

In 2022 there were 295 drugs in short supply

In 2023 there were 323 active drugs in short supply

Just in the last year, there has been a 50-70% rise in drug shortages both short and long term. This has and currently does impact treatment for everything from colds to diabetes to cancer.

As of the writing of this email, February 2025, there are ongoing shortages of various medications, including:

1. Semaglutide: Still on the FDA’s shortage list, despite the FDA’s expected removal of the designation.
2. Tirzepatide: Removed from the FDA’s shortage list, but compounded versions will no longer be widely available.
3. Dronabinol: Used to manage chemotherapy-induced nausea, still in short supply.
4. Chantix: An anti-smoking medication, still scarce due to a 2021 recall.
5. Generic medications: The US relies heavily on other countries for pharmaceutical products, especially for generic drugs, which could be affected by tariffs and supply chain disruptions.

In my office, we’ve experienced shortages on over 25 different drugs beginning two years ago including:

Amoxicillin

Acetaminophen

Aspirin

Adderall

Armour Thyroid

Cefixime

Epinephrine

Levothyroxine

Lithium

Lorazepam

Lidocaine

Lisinopril

Magnesium Citrate

Prednisone

Labetalol

Ozempic

Prochlorperazine

Quinapril

Rifampin

Sucralfate

Semaglutide

Trulicity

These are not simple over-the-counter drugs, and a number of them are essential to daily function and life-saving when emergently needed.

Medication Shortages are Now The Norm

Medication shortages are now quite commonplace around the world. If you have a fever of 103 °F and all you have is a bottle of Tylenol (acetaminophen), for example. Yet it states on the bottle, “Do not use after June 2024,” and it is February 2025 . . .

”              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 medication bottles? Or, is the practice of dating just another FDA drug industry scam, to get us to buy new medications when the old ones that purportedly have “expired” are still perfectly effective?

The simple fact that I, a physician who’s been in the medical trenches for over 25 years, am questioning the trustworthiness and ethics of pharmaceutical companies in general should tell you something . . .

Are Expiration Dates on Drugs Just a Scam?

Having had this happen to multiple patients over the five years, with every one of the drugs above, I’ve scoured the medical databases and medical literature to find an answer.

No sooner can you say, “Screwed, again, by the pharmaceutical industry,” I found my answer.

First, the expiration date, required by law in the United States starting 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.

Based on multiple studies including the Shelf-Life Extension Program (SLEP) undertaken by the FDA for the Department of Defense, roughly 90% of the over 3000 drugs in their database maintain their potency for six years after the expiration date.

Second, medical authorities uniformly state that it is safe to use a drug past its expiration date, no matter how “expired” the drugs have become. There are a few exceptions that I have noted below.

Third, studies conducted by the US Department of Defense reveal that even 10 years after their expiration date, most drugs still have a good deal of their potency.

One of the largest studies ever conducted that supports the above points about “expired drug labeling” was done by the U.S. military. 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. They were facing the daunting process of destroying and replacing its supply of drugs every two to three years. So, the military 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 Thinks You and I Should Follow Expiration Dates

It should be noted, however, that the FDA (likely because their attorneys could smell blood in the water) cautioned there isn’t enough evidence from the study program, which is weighed towards drugs used during combat, to conclude most drugs in consumers’ medicine cabinets are potent beyond the expiration date.

However, Joel Davis, a former FDA expiration-date compliance chief, stated 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 for many years.”

Bayer tested aspirin 4-years-older than it’s expiration date. It remained 100% effective, Bayer has never tested aspirin beyond 4 years, Mr. Allen said. But, Jens Carstensen has.

Dr. Carstensen, professor emeritus at the University of Wisconsin’s (US) pharmacy school, who wrote what is considered the main text on drug stability, said, “I did a study of different aspirins, and after 5 years, Bayer was still excellent.” Aspirin, if made correctly, is very stable.

Which Medications are Most Likely to Degrade?

To be completely frank, there’s really no way to know if a drug is safe unless it is actually tested for potency. Based on the research that has been done, 90% of the drugs in pill or capsule form are probably stable for at least six and possibly 15 years beyond the expiration date.

Here are the common sense measures I give to you and to my patients about those drugs that are known to degrade:

”              Insulin is used to control blood sugar in diabetes and is susceptible to rapid degradation after its expiration date.

”              Oral nitroglycerin (NTG), a medication used for angina (chest pain), will lose its potency quickly once the medication bottle is opened.

”              Vaccines, biologicals or blood products could also be subject to quick degradation once the expiration date is reached.

”              One review has noted that outdated tetracycline antibiotics, chemotherapy agents, antiviral drugs, aminoglycosides, and anticonvulsants may lead to Fanconi Syndrome.

”              Don’t use eye drops beyond their expiration date as they are likely to degrade.

”              Medicines that look old, powdery or crumbling medicine, drugs with a strong smell, or dried up medicine (as in the case of ointments or creams) should always be discarded, expired or not.

”              Discard any expired injectable medication. If expired or not, always discard injections if cloudy, discolored or with visible floating particles.

How Should You Store Your Medications?

Proper storage of medications helps extend their potency. The bathroom and medicine cabinet IS NOT the ideal places to store medications due to heat and humidity. Similarly, medications SHOULD NOT be left in a hot car or glovebox, or in freezing weather.

Most oral, solid medications remain most stable in dry, cool spaces away from light. Keep the prescription bottle caps tightly closed and always keep medications out of reach of children and pets.

Look at your package insert for proper storage instructions, or ask your pharmacist. Be careful to follow the instructions for refrigeration or freezing.

Now, after all this reading, I think I will go take a big swig of that 10-year-old packet of Alka-Selzer in my cabinet. Maybe it will ease the chest pain, heartburn and nausea I am now feeling after calculating the billions of dollars the pharmaceutical industry has bilked out of you and me every year after discarding perfectly good drugs to buy new ones because we’ve blindly trusted them.

 

References:

1. American Medical Association. “Pharmaceutical Expiration Dates.” Report 1 of the Council on Scientific Affairs (A-01). July 25, 2001.
2. Expiration Dating Extension, U.S. Food and Drug Administration (FDA). April 7, 2022 at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension
3. Woods M. Drugs may outlast label date. Post-Gazette National Bureau. May 30, 2005. https://www.post-gazette.com/news/health/2005/05/30/Drugs-may-outlast-label-date/stories/200505300166
4. Simons FER, et al. Outdated EpiPen and EpiPen Jr autoinjectors: past their prime? J Allergy Clin Immunol 2000;105:1025.
5. Don’t Be Tempted to Use Expired Medicines. U.S. Food and Drug Administration (FDA). Revised 2/08/2021. Accessed July 20, 2022 at https://www.fda.gov/drugs/special-features/dont-be-tempted-use-expired-medicines
6. Iserson KV. Should we use expired drugs when necessary? Ethics in Emergency Medicine. Jour Emerg Med. May 2021. 60(5): 669-673.
7. Lyon RC, et al. Stability profiles of drug products extended beyond labeled expiration dates. Jour Pharm Sci. July 2006. 95(7): 1549-1560.
8. Kramer TAM, Do Medications Really Expire. Medscape General Medicine. 2003; 5(3). Online. https://www.medscape.com/viewarticle/460159
9. Litzinger M, Boatman M, Juarez I, et al. Fanconi Syndrome. US Pharm. 2011;36(6):HS12-HS16. Accessed July 20, 2022.
10. Kassel L, Jones C, Mengesha A. Epinephrine drug degradation in autoinjector products. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2491-2493. doi: 10.1016/j.jaip.2019.04.028. Accessed July 20, 2022.

Adam S Nally, D.O. 14800 W MOUNTAIN VIEW BLVD Suite 250 SURPRISE, Arizona 85374 United States (623) 584-7805