(CNN Spanish) – Surely this has happened to you: you need to take a medication, but then you realize that it expired weeks or months ago. What happens if you take it? Will you have an allergic reaction or will you be poisoned?
In this episode of our podcast “In Consultation with Dr. Elmer Huerta,” we explain what’s behind those expiration dates, as well as what the authorities say about whether or not it’s safe to take expired medicine.
You can listen to this episode on Spotify, on our YouTube channel or on your favorite podcast platform, or read the transcript below.
Hello, welcome to this new episode of “In consultation with Dr. Huerta”, your favorite health podcast on CNN en Español. Greetings from Dr. Elmer Huerta, I hope you are well.
One of the most common questions people ask is whether a medication can be used beyond its expiration date.
Is it safe to consume it? What are the criteria used by pharmaceutical companies to decide the expiration date on a medicine? What is really known about expired drugs? Do they work? Do they intoxicate? Let’s see.
Why do medications have an expiration date?
With hundreds of medications, either prescription or over-the-counter, and in an effort to regulate their use, production, and handling, the United States Food and Drug Administration (FDA) promoted two important initiatives in the 1970s.
The first was to make an inventory of all the drugs that existed in the country and assign them a number called the national drug code.
For this, in 1972, the United States Congress approved the Drug Listing Act to have an updated list of all commercially distributed drugs. It also further provided that all pharmaceutical establishments, foreign or local, involved in the manufacture, production, or compounding of drugs sold in the country must be registered with the FDA.
The second initiative on the subject was implemented in 1979, when the FDA established that all medicines sold in the country must have their expiration or expiration date clearly printed on their packaging.
What does the expiration date mean?
The expiration date is defined as “the date after the drug’s manufacture until the manufacturer guarantees its potency and safety.” Most drugs have an expiration time of one to five years.
The point is that this definition is subject to multiple interpretations.
As defined, the expiration date does not say whether after that date the drug in question loses potency or is dangerous for the person using it. It simply says that, as of that date, the drug is guaranteed potency and safety.
It is as if a professional soccer coach told the public that he “guarantees” that his team will be in good physical condition “for at least 20 minutes of the first half.”
But, knowing that a professional team is capable of playing the 90 minutes of the game without problems, that “guarantee of a minimum of 20 minutes of performance” that the coach gives does not make sense.
But that is how the definition was established and there was no further questioning of that decision to have an expiration date for the drugs.
A change of perspective in the United States
Until in the 1980s, institutions such as the Centers for Disease Control and Prevention (CDC) and the Department of Defense began to question the economic losses caused by the destruction of tons of expired medicines.
By the way, the Department of Defense stores large quantities of drugs for use in emergencies.
For example, in 1986, the US Air Force asked the FDA to tell it if it was possible that some drugs could be stored and used beyond their expiration date.
In response, the Department of Defense and the FDA created the Drug Shelf Life Extension Program. It was intended to avoid the need to replace entire stocks of medicines and vaccines every few years at significant expense.
The rationale for the program — and the FDA states this in its documents — was that it had been proven through scientific studies that, when stored correctly, certain products could remain stable well beyond the expiration dates indicated on the label.
The program required products selected for storage beyond their expiration date to undergo periodic stability testing by the FDA.
How effective are expired medications?
A program report published by the FDA in 2006 found that, stored under regular conditions of humidity and temperature:
- 88% of the 122 products stored in 3,005 lots were in perfect condition after an average of 5 and a half years after the expiration date;
- And the remaining 12% were still doing well 4 years later.
Some products were even good 23 years past their expiration date.
Some that failed to maintain their potency include:
- Albuterol, a common asthma inhaler,
- Diphenhydramine Allergy Spray
- And a local anesthetic based on lidocaine and epinephrine.
According to the report, between 2006 and 2009, the government saved between US$600 and US$800 million annually on medicines that were not destroyed simply because they were past their expiration dates.
Other studies confirm that drugs can maintain their usefulness after their expiration date.
For example, a review article in The Medical Letter dated December 7, 2015 reveals that medications such as captopril (for blood pressure), theophylline (for asthma), and injectable powdered cefoxitin (a broad-spectrum antibiotic), stored at 40 degrees and 75% humidity, they were stable for one and a half to nine years after the expiration date.
As we can see, these storage conditions could lead one to think that the medicines would be spoiled, but this was not the case.
Is there a date limit?
Several other studies have revealed that drugs still have potency many years after their expiration date.
For example, in another study, theophylline remained stable 30 years after the expiration date. The anesthetic lidocaine, found in Oman, stored at 57 degrees two years after its expiration date, worked perfectly.
Similarly, sodium thiosulfate can remain active for 16 years. Atropine sulfate, for 15 years. The antibiotic ciprofloxacin, for 13 years, and the antivirals amantadine and rimantadine worked well 25 years after their manufacture.
On the other hand, a study published in November 2012 in the Archives of Internal Medicine analyzed the potency of eight medications containing 14 different products that had been found stored in their original containers 28 to 40 years after their date of manufacture.
Twelve of the 14 products, or 86%, retained more than 90% of the initial drug concentration, meeting the minimum concentration condition for use.
What about liquid medicines?
It is accepted, however, that liquid medicines, solutions, and suspensions are less stable than tablets, capsules, and powders for injection.
In this regard, it is recommended that if an injection ampoule is cloudy or has precipitation, it should be immediately discarded.
Similarly, eye drops should not be used after their expiration date because the preservative that prevents bacterial contamination of the medication can evaporate and the drops can allow the growth of bacteria that can cause serious eye infections.
Other medicines that should not be used past their expiration date include EpiPen epinephrine injections, except in an emergency and if a new injection is not available, as well as nitroglycerin used to relieve the pain of tonsillitis. chest caused by poor blood circulation in the coronary arteries of the heart, insulin for diabetes, and liquid antibiotics.
Is it dangerous to consume an expired medicine?
In relation to the possible harm that the use of drugs that expired on their expiration date may cause, The Medical Letter says that, with the exception of a debatable case of kidney poisoning by a tetracycline that is no longer manufactured, there is no scientific study that has reported human damage due to the use of expired medications, concluding that expired medications are not toxic and the vast majority continue to work after their expiration date.
Of similar opinion is Dr. Cathleen Clancy, associate medical director of the National Poison Center, an organization affiliated with George Washington University, who told ProPublica that she had never heard of people being harmed by expired medications.
Knowing that according to data from the Centers for Medicare and Medicaid Services (CMS) prescription drug spending in the US totaled $370 billion in 2019, the savings from allowing the use and donation of drugs would be enormous. expired medicines, especially in low- and middle-income countries.
Obviously, in this podcast we are not promoting the use of expired medications, but rather that you be well informed and if you have any questions about taking a medicine beyond its expiration date, consult your doctor and agree on what you should do.
Do you have questions for Dr. Huerta?
Send me your questions on Twitter, we will try to answer them in our next episodes. you can find me at @DrHuerta.
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