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With the FDA taking action against unscrupulous sellers, here is what you should know about taking expired medicine:
Many times, people reach for headache or flu pills and discover that they have expired. Still, they take the medicine. But what does it matter? Does the headache go away or continue or is this a fatal mistake? A law was passed in 1979 which requires drug manufacturers to stamp an expiration date on their products. From the date of manufacture to the expiry date, the manufacturer can guarantee the safety and expected effectiveness the drug. But, is the medicine still powerful and safe after the expiry date?
Does the Potency of Drugs Expire?
A study known as the Shelf Life Extension Program was carried out by the American Food and Drug Administration at the request of the U.S. military. The military had noticed that they were throwing away many drugs every year due to expiry. The study found that 88% of the 122 drugs studied, prescription and non-prescription, were perfectly good to use even 15 years after the expiry date. As a result, the FDA stamped new expiry dates that ranged between 12 months and 184 months (up to 15 years).
What is known now is that most medicines are generally safe and potent even after expiry if they are kept in their original packaging. However, if a medicine is opened for dispensing or consumption, as what happens in pharmacies and hospitals, the storage conditions may accelerate the decline in potency and safety.
Tablets and capsules appear to be most stable beyond the expiration date. Solutions and suspensions that require refrigeration may lose their power faster and may develop bacteria.
Exceptions to the Rule
According to research, insulin, nitroglycerin and liquid antibiotics do change significantly with time. Another exception is tetracycline because of the 1963 report that linked tarnished tetracycline to Fanconi Syndrome. However, researchers do not agree on this. They question the accuracy of this case report and the formulation of tetracycline in question is no longer used.
The Necessity for an Expiry Date
From the research done by the FDA, the original strength of drugs may be lower after the expiry date but it is still there after many years. Manufacturers stamp a conservative expiry date to make sure that you get everything that you paid for. At least, up to the expiry date, they can guarantee the full potency of the drug but after that date they know the potency declines. Therefore, they will not take legal risks by guaranteeing their products’ stability, potency and safety after the expiry date. After all, after a consumer or dispenser opens the original package, the manufacturer has no control over heat, humidity, light, and other storage factors that affect stability.
Another thing that affects expiry dates is time and money. Manufacturers prefer to focus on research and development to create new drugs instead of testing old drugs all the time for potency.
The Risks of Taking Expired Medicines
It is good that most medications remain potent beyond their expiry dates especially if they are kept in a cool place such as a refrigerator. However, there are risks associated with certain expired medications.
1. Loss of potency is a major health risk when it concerns antibiotics. There is the possibility of failing to treat the infection and high risk of developing antibiotic resistance.
2. As a general rule, drugs that exist in solution, e.g. injectable drugs, should be thrown away if they form a precipitant or if they look discoloured or cloudy.
3. Expired medicines that contain preservatives, such as eye drops, may be unsafe after their expiry date. When the preservative has worn out, bacterial growth may take place in the solution.
The next time you face a dilemma concerning expired medicines, you know what to do. If an antibiotic is expired and you need it, you are better off throwing it away and getting a new prescription. If you have liquid medicines that expired many years ago, they are possibly tainted so throw them away and get fresh medicines. Pills such as headache pills, etc. you are generally safe taking them if you cannot reach a pharmacy in time. If you are not sure what to do in any situation, contact the nearest pharmacy for advice. In life-threatening situations where it is difficult to access medicines, it is wise to use whatever is available even if is expired, while taking the person to a safe place for medical care.
You can also visit PharmEasy for information on how to avoid fake and illegal pharmacies: it connects you to local registered pharmacies in India. If your medicine is expired and you need it fast, you can consult a doctor online and get a prescription online so your medicine will be delivered on time.