All medicines have an expiry date printed on their package. Do these
expiry dates have any meaning? Do the drugs lose their potency after the
expiry date? Are they dangerous to use after the expiry date?
Numerous experts have addressed these issues and their articles are available on the internet. Some such websites are sciencebasedmedicine.org (the journal "Science Based Medicine"), health.harvard.edu (Harvard Medical School) and rense.com (Dr. Richard Altschuler, Professor, University of Michigan Medical School). All of them seem to agree on the surprising answer "No" to the above questions
The purpose of printing the expiry date on medicines is to make sure that the medicine does not lose its potency before the expiry date and so the consumer does not waste his money on a worthless product. Most medicines do not lose their potency long after the expiry date, but no one seems really interested in determining exactly when a medicine starts losing its potency.
Expired drugs present a serious economic and environmental problem. The U.S. Drug Enforcement Administration collects expired drugs from the public in the month of April every year. This year, it collected in one month 276 tons of expired medicines. This much medicine costs a huge amount of money and disposing it poses a big environmental problem.
Why Drug Companies Are Not Interested in Determining The Expiry Dates Accurately
There are two basic reasons, lack of time and desire for higher profits. Let us say that a drug has a life of 10 years. To determine the life, the drug company will have to test the drug for at least 10 years. If it does not release the drug till the testing is finished, rival companies will release competing drugs and steal the market. So drugs are put through accelerated testing, but it is not clear how accurate these tests are.
Even if the accelerated tests are accurate and the life of the drug is found to be 10 years, will the company admit it? If it does so, once people buy the drug, they will not buy it again for 10 years. Any profit-driven company can not afford to do it. Declaring the life of the drug is only 2 years is financially quite beneficial to the company. People will throw it away after 2 years and buy a fresh supply. According to Francis Flaherty, former director of the drug testing programme at the Federal Drug Administration (FDA) of USA, "Manufacturers put expiration dates on for marketing, rather than scientific reasons".
Bayer aspirin has a declared life of 2 years, but when Bayer tested 4-year old aspirin, it found that it was 100% effective. But the declared life of Bayer aspirin remains unchanged. And Bayer has never tested aspirin beyond four years! According to Dr. Jens Carstensen who has written the definitive book on drug stability, aspirin lasts a long long time.
The drug companies may underdeclare the life of their drugs, but how do we know that they retain their potency after the declared life? For that information, we have to depend on the only published material till now on the determination of the expiration periods of drugs, namely, the non-accelerated tests conducted by the FDA on more than 300 drugs between 1993 and 2008. In its studies, FDA found that 90% OF THE DRUGS WERE SAFE AND EFFECTIVE EVEN 15 YEARS BEYOND THE EXPIRATION DATES!
According to Joel Davis, a former FDA expiration-date compliance chief, most drugs are probably as durable as those tested by FDA. Noted exceptions to this include nitroglycerin (used to treat heart conditions), insulin and some liquid antibiotics.
Are Expired Drugs Still Safe?
There is no published data which shows that expired drugs have caused any harm. A case of kidney failure caused by expired tetracycline was reported in 1963 in the Journal of American Medical Association, but this paper has been seriously disputed by experts.
Expiration Dates for Ayurvedic and Homeopathic Medicines
Determining the expiration date for a drug involves identifying the "Active Pharmaceutical Ingredient" of the drug and measuring how it decays in time. Ayurvedic and homeopathic medicines diluted to typical concentrations, have no identifiable active ingredients and so can not have expiration dates. But the Drugs and Cosmetics Act, 1940 makes it mandatory to print expiration dates for Ayurvedic and homeopathic drugs also.
What Should The Consumer Do With Expired Drugs?
Experts feel that if the expiration date passed a few years ago and it's important that your drug is absolutely 100% effective, you might want to consider buying a new bottle. But if your life does not depend on an expired drug (such as head ache, allergy, etc.), take it and see what happens.
B.V. Shenoy, Mysore Grahakara Parishat
Numerous experts have addressed these issues and their articles are available on the internet. Some such websites are sciencebasedmedicine.org (the journal "Science Based Medicine"), health.harvard.edu (Harvard Medical School) and rense.com (Dr. Richard Altschuler, Professor, University of Michigan Medical School). All of them seem to agree on the surprising answer "No" to the above questions
The purpose of printing the expiry date on medicines is to make sure that the medicine does not lose its potency before the expiry date and so the consumer does not waste his money on a worthless product. Most medicines do not lose their potency long after the expiry date, but no one seems really interested in determining exactly when a medicine starts losing its potency.
Expired drugs present a serious economic and environmental problem. The U.S. Drug Enforcement Administration collects expired drugs from the public in the month of April every year. This year, it collected in one month 276 tons of expired medicines. This much medicine costs a huge amount of money and disposing it poses a big environmental problem.
Why Drug Companies Are Not Interested in Determining The Expiry Dates Accurately
There are two basic reasons, lack of time and desire for higher profits. Let us say that a drug has a life of 10 years. To determine the life, the drug company will have to test the drug for at least 10 years. If it does not release the drug till the testing is finished, rival companies will release competing drugs and steal the market. So drugs are put through accelerated testing, but it is not clear how accurate these tests are.
Even if the accelerated tests are accurate and the life of the drug is found to be 10 years, will the company admit it? If it does so, once people buy the drug, they will not buy it again for 10 years. Any profit-driven company can not afford to do it. Declaring the life of the drug is only 2 years is financially quite beneficial to the company. People will throw it away after 2 years and buy a fresh supply. According to Francis Flaherty, former director of the drug testing programme at the Federal Drug Administration (FDA) of USA, "Manufacturers put expiration dates on for marketing, rather than scientific reasons".
Bayer aspirin has a declared life of 2 years, but when Bayer tested 4-year old aspirin, it found that it was 100% effective. But the declared life of Bayer aspirin remains unchanged. And Bayer has never tested aspirin beyond four years! According to Dr. Jens Carstensen who has written the definitive book on drug stability, aspirin lasts a long long time.
The drug companies may underdeclare the life of their drugs, but how do we know that they retain their potency after the declared life? For that information, we have to depend on the only published material till now on the determination of the expiration periods of drugs, namely, the non-accelerated tests conducted by the FDA on more than 300 drugs between 1993 and 2008. In its studies, FDA found that 90% OF THE DRUGS WERE SAFE AND EFFECTIVE EVEN 15 YEARS BEYOND THE EXPIRATION DATES!
According to Joel Davis, a former FDA expiration-date compliance chief, most drugs are probably as durable as those tested by FDA. Noted exceptions to this include nitroglycerin (used to treat heart conditions), insulin and some liquid antibiotics.
Are Expired Drugs Still Safe?
There is no published data which shows that expired drugs have caused any harm. A case of kidney failure caused by expired tetracycline was reported in 1963 in the Journal of American Medical Association, but this paper has been seriously disputed by experts.
Expiration Dates for Ayurvedic and Homeopathic Medicines
Determining the expiration date for a drug involves identifying the "Active Pharmaceutical Ingredient" of the drug and measuring how it decays in time. Ayurvedic and homeopathic medicines diluted to typical concentrations, have no identifiable active ingredients and so can not have expiration dates. But the Drugs and Cosmetics Act, 1940 makes it mandatory to print expiration dates for Ayurvedic and homeopathic drugs also.
What Should The Consumer Do With Expired Drugs?
Experts feel that if the expiration date passed a few years ago and it's important that your drug is absolutely 100% effective, you might want to consider buying a new bottle. But if your life does not depend on an expired drug (such as head ache, allergy, etc.), take it and see what happens.
B.V. Shenoy, Mysore Grahakara Parishat