Depending on the purpose. At least before using expired drugs, you should check them by LC/MS, purity, contamination, and so on.... Otherwise your results are nothing.

The answer is both yes and no. Although it is ideal not to use expired drugs, they may be the only resort in desperate situations. The problem with an expired drug can be:

1. A reduced content of the active ingredient: This usually is not an issue, for example in the case of an analgesic or a multivitamin. However, it becomes a problem in the case of drugs like antibiotics (plasma concentration below MIC - leading to resistance) or hormones (thyroxine, OCPs, etc) or drugs like digoxin or antiarrhythmics.

2. Formation/generation of toxic metabolites: though this list is small, it is important in case of drugs like tetracyclines that are still widely used in under-developed countries due to their low cost.

So you see, the question "Can we use an expired drug, cannot be answered with a simple Yes or No".

Dear Ms Veemala,

Facts share below by Drs.Nair & Tsukamoto are facts about expired drugs.

In my opinion the expiration date of any medication is a conservative estimate of a time until when the medication retains its potency. Conservative because it is determined by subjecting the medication to very strenous and unfavourable conditions of transport and storage (like extreme temperatures and handling). This is termed accelerated stability studies and the expiration date is determined from the data obtained from this kind of an experimental procedure (not real time).

As a pharmacist in making your understanding of the science behind expiration date should not be extended to the patient via counselling (which will be inappropriate knowing the risk involved). Always consumer safety is a primary objective. On the contrary you could always advice the patient to adhere strict storage and handling procedures to enable them to use the medication till the maximum date of labelled expiry date.

wish you all the best

regards

Dr C Kannan Janakiraman

Biologicals such as insulin clearly have a shelf life. More typical drugs such as penicillin have a rather long one. I think it is interesting to purchase a drug from sigma and it comes with no expiration and we use it for years with no problem. The same drug, packaged with stabilizers in consumer form has one, rather curious. Case in point, I recently used a vial of pentobarbital that was over 20 years old to sedate rats with no problem at all.

But you do need to use caution, tetracyclines are well known to decompose and there have been cases of kidney damage.

You can extend the shelf life of drugs considerably by storing them in a dry freezer (not liquid drugs) and allowing them to come to temp before opening them. We do this rather routinely in our lab, esp for drugs not used very often.

Except some sensitive drugs most of the molecules are stable based on stability data & potency shelf life can be extended.

eg. Generally most of the product sold in the market are of 3 years shelf life , If a product is stable over a period of shelf life. What has happened it to get expired in 4th year ?

Dear friend..

expiry date of drugs means only 10 % of drug degrades , is called self life of drug ...but in case of potent drug its too much ..we may use only OTC drug which may safe for human body after expiry date. apart from these it may be risky ....as you asked in case of antibiotics only fluroquonolones may use but after testing of stability .those antibiotics are obtained from bacteria and fungus cant use...

En Colombia la fecha de expiración de los farmacos esta relacionada con el tipo de porducto que se distribuye. Se regramentan desde dos a hasta diez años de expiración dependiendo si es un alimento o un farmaco.

Expiry date of a drug doesn't mean that the dug is rock stable up to that date and immediately starts degrading after that date. Usually, most of the drugs starts degrading and continues to lose their quality even before expiry. But, Expiry date is the date that indicates uptil when the drug can be safely administered to the patient and until that time it can best serve the purpose without losing its pre-defined quality specifications. Moerover, the expired drug suffers from following disadvantages.

1. Decreased potency of the active dubstance.

2. Increased impurity levels.

Though decreased potency affects the efficacy, it doesn't harm the patient. Rather, increased impurity levels may cause serious safety concerns as they may have different mechanism of action than the drug. Further, we have no clarity on affects of unknown impurities on patient safety and now-a-days there is increased focus on Genotoxic impurities also which will cause genetic affects over time on patients and also on their next generations.

Hence, except in case where it is unknowingly taken, it is ideally not preferred to take the expired drugs.

Nobody likes to invite further issues being a patient, Right!

Thanks for the nice question.

Good luck!!

For common understanding for the tag question the answer is "" BIG NO"

..When you buy medicine and consume you do so believing it on the " Printed BRAND and GENERIC Name as well Chemical Name" then why question the "expiration date " which is also clearly printed on the label "........do not use if the product is expired......as no one can answer specifically what will happen .....

...some chemical and spectral tests may give purity profile of API but not the impurities developed after expiry date and their bio -efficacy or bio-adversity.........

Even if we check the drug and run a perfect!!! QC, my answer is NO. If we say yes actually we are recommending relabeling and not supporting patients rights and safety although it happens in many countries.

To tel philosophically whichever substance or body takes birth one or the other day it has an expiry.so wt u can expect from an expired body? It is impotent, useless, deteriorate and can be harmful if still used. Isn't it? For eg: digitoxin-if not stored properly or used after expiry, absorbs moisture leads to deterioration of purpurea glycosides n loses its action as cardiotonic.

There may be intermolecular interaction leading to untoward reactions due to hygroscopic nature in case of multi-vitamin formulations.

Plant derived drugs usually have complex chemical nature like opioid drugs, vincristine, taxol, lycopene,etc. There may be inter-ionic interaction leading to formation of free radicals, unwanted derivatives leading to be fatal, when used after their expiry date. This much i can express about the question.

Well from the above comments it is cleared that the expired drugs could be harmfull or may be a source of un-wanted effects. So there should be "No use of expired drugs in any case"

Original research papers addressing the stability of the compounds under different conditions are very useful for obtaining a general idea of their longevity.

The expiration date of pharmaceuticals specifies the date the manufacturer guarantees the full potency and safety of a drug. Most medications continue to be effective and safe for a time after the expiration date. A study conducted by the U.S. Food and Drug Administration covered over 100 drugs, prescription and over-the-counter. The study showed that about 90% of them were safe and effective as long as 15 years past their expiration dates. Joel Davis, a former FDA expiration-date compliance chief, said that with a handful of exceptions - notably nitroglycerin, insulin and some liquid antibiotics - most expired drugs are probably effective.But You may need to discard the drug after expiration date because some meds can lose their potency or be toxic after a certain date, or after being exposed to sunlight, humidity, etc.

There are very few reports of human toxicity due to ingestion, injection or topical application of presently available medicinal products after their expiration date. There are very few examples where the products of degradation are significantly more toxic than the original active pharmaceutical ingredient. Tetracycline gets decomposed to epianhydrotetracycline and the decomposed product is shown to cause renal tubular damage. Chloroquine can produce toxic reactions attribute to photochemical degradation. Phototoxicity has also been reported following administration chlordiazepoxide and nitrazepam. Infusion of degraded Penicillin G is known to cause sensitization of lymphocytes and formation of antipenicilloyl antibodies. . Dabigatran (Pradaxa), a recently approved medication for the prevention of stroke in patients with atrial fibrillation, has special stability and storage precautions. Dabigatran is subject to loss of potency upon exposure to moisture, which could result in lower stroke prevention efficacy.

For more information about “FDA Drug Expiration Date Rules” I refer you to http://www.ehow.com/list_6873384_fda-drug-expiration-date-rules.html .

Generics or copies have usually lower stability than innovative molecules and several regulatory offices in Latin American countries approve them with a lower DOE. Each is relative. I disagree with the "big NO"of some of my peers. In clinical research when some type of molecules are "expired" pharmaceutical companies usually allow an extension of 6 months after the DOE (considering appropriate conditions of storing and handling).

The tag question is related to "usage of expired drugs".....which is primarily for commercialized drug formulations( not for drugs under experiments in a R&D lab ) and the expiration time is fixed based on stability data at various conditions of drug exposure and fixed by FDA /Health authorities based on feed back from stability data provided by various institutions and manufacturers ( and also some follow up of marked drugs) and there is a common code for manufacturers under Food and Drugs act. to have same expiration date for a particular formulation drug and all manufactures has to follow the same guidelines .

Hence it is BIG NO for use of any commercialized drug after its expiry date printed on the labels by the manufacturers them selves.

Thank u all for ur answers..they are indeed helpful!

When once the expiry date is mentioned, it should be taken seriously for the patient's safety. Being pharmacists we are well aware that not only the physical degradation takes place but also the chemical degradation takes place and it may be dangerous for the patient

I Feel Minoo had described it very well ,

Only I wanted to add that we need to justify

our opinion logically by confirming its intended usage

Expired drugs are a topic that has been discussed many times.

As a pharmacist before I became a scientist, in the USA expiration dating is not the true measure of the physical stability of the drug but rather is an estimate in the worst possible storage conditions and accelerated stability testing of the final drug product which simulates by being at 40C and 80% relative humidity for 3 months. Under these conditions it is estimated to simulate 3 years at normal conditions of temperature and humidity. I have tested the physical stability of expired drugs and for some drugs has been over 10 years before the degradation of the drug occurs. I have also seen drugs that are not stable beyond 3 years. The second question is a difficult one to answer since depending upon the degradation product you may have a pharmacological activity however does it create any toxic effects is a question that depends upon the drug itself. In most cases the degradation of the drug is not as toxic as the primary drug and so toxicity is not a problem. One example of a drug that has toxicity upon

going past its expiration date is Ascorbic acid or Vitamin C which has been documented to cause kidney damage.

Dear All,

I would like share one of my experience

May be around 15 years ago I was working on formulation combination of Pantoprazole + Domperidone during analysis I found a carton containing blisters of Pantoprazole 40 mg expired a year back . I have subjected the blister for analysis and found satisfactory result it is again assured & we have increased shelf life by a year .

So in short we can not simply comment as expired product is not having any effect or toxic effect needs proper justified data for it

Beste Ms Veemala

you are lucky , you have this much experienced data (commints) from all over the world , remember when (before last 20 years) no such facility (internet) was available and this expiry date had been established due to avoidance of any emergency for a patients,

In my opinion the expiry means DEATH so when pt will use after expiry date means using dead product.

As you know, it is established after long and accelrated stability studies and many expertise has been involved. So I suggest rather recommend NO PRODUCT CAN BE USED after expiry date. That's all.

This research add information regarding this topic on expired drugs. These are bad news for the radicals of the BIG NO.

http://archinte.jamanetwork.com/article.aspx?articleid=1377417

It will interesting to see if FDA authorities all over the world can remove the expiration dates for commercial medicines based on this article ?

or extend expiration years at least for the mentioned molecules.in the article...which will help many manufactures

I am sure they will not because there are many factors involved in fixing expiration dates ( not just one article on purity profile but also impurity developments at various shelf life conditions. which the article has not covered.).....

Till a common code arrived for each molecule by concerned authorities for manufacturers , it is not advisable in the interest of common patients all over the globe and a BIG NO for use of expired commercial medicine formulations.

Dr. Chakravarthy based his answer on the regulatory agency that called on Teva Pharmaceuticals to withdraw the use of its generic bupropion contradicting its previous update on the issue in 2008, when regulators said "the drugs are essentially the same". Can we believe them??? (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm153270.htm).

By the way, extending the expiration dates will not help manufacturers. On the contrary, it will be useful for many patients that could benefit with lower prices and better quality than cheaper generics like those marketed by Teva. There is a simple market rule: higher availability, lower prices!

Dr.Jorge Tamayo..... we will mislead common man if we take isolated cases to discuss and dangerous to generalise no ills on use of expired drugs (many reports are there on bad effects of expired drug usage).

Can you give any details as referred by you that after 2008 case did any manufacturer is allowed to manufacture Generic bupropion with out or extended expiration date.if not just think why? may be similar finding are not reported all over the world nor supplemented by stability data of various manufacturers themselves ( API can be same in drug formula but excipients and binders differ from formula to formula and have different degradation effects and no authentic references are there to show all impurities after expiration are same in all marketed formulae)

It may be true that some drugs may found cheaper to patients without any expiration but as a strong believer that self medication it self as harmful practice with out proper medical expertise.......I can not support the use of expired drugs which may more harm innocent patients.

It is not correct to say that only patients do benefit if expiration date is not there....trust you are aware that annually millions of USD worth expired drugs are recalled from market by manufacturers ( for destroying or rarely for reprocess) so no expiration will benefit manufacturers also... but we can not suggest just on one or two case studies....

Yes if universally accepted and approved by regulatory authorities with scientific data for individual drugs we can support ...till such time it is a BIG NO for use of expired drugs..

Expired drugs are not dispensed to patients in the US. However, recent studies have shown that some drugs can remain potent for up to 10 years. As mentioned previously, storage and transport conditions may affect this.

Yes you can use. But it is all about your risk. Even some drugs get expire before the actual expire date. The expiry itself says it's not worthy enough to use. You only mentioning in question that the expired product will have reduced efficacy, why..?

Because the active component get degraded and converted to some toxic or non-toxic compounds which don't have efficacy for intended therapy.

So, my final opinion is 'NO' to the expired drugs and it's all about a life.

in my opinion Expiry dates for drugs can vary dramatically. One of the shortest for a drug in common use is injectable epinephrine known as the “Epipen”, carried by those with severe allergies. Epinephrine for injection is notoriously unstable, and you’re lucky to find a product that expires longer than 18 months after you get it. Other drug products are highly sensitive to moisture, requiring dispensing in specialized containers with dessicants to trap moisture and enhance stability. Many liquid antibiotics have very poor stability, so they must be prepared in the pharmacy at the time of dispensing. Refrigeration is necessary for other drugs, ranging from vaccines to eyedrops, which keeps the dosage form stable.

It is important to keep in mind that the expiry date of a drug is based on testing of previously unopened products, stored in its original container, and maintained under typical conditions. Once you open a bottle, or transfer it to another container (like a prescription vial), the manufacturer’s expiry date is no longer reliable. That doesn’t mean a drug will become ineffective rapidly, but the stability could be compromised once it has been introduced to light, heat, and humidity. Humidity’s effects are frequently noticable with old bottles of Aspirin (acetylsalicylic acid) which breaks down via hydrolysis to salicylic acid and acetic acid giving old bottles a characteristic vinegar odour.

http://www.sciencebasedmedicine.org/.../the-drug-expiry-d...

I think that some expired drugs can be used when their validity can be confirmed through quality control (physical and chemical) analyses especially for those dosage forms that are stated in the official monographs like BP & USP especially when the tests for degradation products, if available (or related compound as stated in the monographs) are still within the acceptable limits. also when the tests for the performance of the dosage form (like dissolution test) are also within acceptable limits especially when these medications are stored properly. I don not mean that we should accept the idea of using the expired medications instead of disposing them, but sometimes it might be necessary to consider some preparations that might be expensive or rare in some countries or in some widespread epidemics or war time when other choices are not easily or rapidly available.

Dr. Colleen, thank you for this very curious question!

I have unfortunately "rich" experience with drugs, which has passed hands-expired products!

I was forced to work in a bloody war in Bosnia from 1992-1995 g. when simply due to the blockade in which we have had to give this kind of drugs, although I was unhappy I knew all the risks and therapy or other medication was not!

That in the future my response more broadly, because I myself had a lot of frustration and trauma of that period, now I'm not able to even have concentrations (I worked mainly as a surgeon, an internist by profession itself), all these I say!

Best  Regards

Dear Dr.Coolen

As I promised yesterday today I will present its "rich experience" with drugs whose validity has expired,! The bloody war in Bosnia from 1992-1995, I worked mainly as a surgeon even though I'm an internist - nephrologist!

Because of the isolation in which my country was not able to purchase new medicines, medical supplies and we gave it, only what we had! It was my unwritten empirical evidence, because the other solution is not any!

With the tacit approval of colleagues in international Humanitarian organization we gave drugs whose date validity expired at the longest of 6 months to a year!

Perhaps some colleagues gave the older medications but I'm just talking about my experience and in the name of a colleague with whom I worked in my hospital!

I did not notice any major adverse reactions in patients, which gave to these drugs by six months to a year which has expired!

I did not notice either to a somewhat lower operating-less affected!

This is my only empirical experience!

I was unable, for objective reasons to do, a serious analysis to prove objectively about what to write up!

Greetings

Jasenko Karamehic

Instead of a conclusion I will say the following:

That as a teacher of pharmacology and clinical pharmacology have no right to suggest, as the correct thing with me colleagues in a bloody and terrible war in Bosnia (1992-1995) worked (although we were forced) to give medications, which expired because this is contrary to both ethical and pharmacological regulations, is strictly forbidden!

I would like to only present only as one of their empirical experience, that it was a normal situation in my country and that there was no war I never experienced, not all personal traumas and frustrations that go with it!

Greetings