Expired Medications – Are They Safe? Are They Effective?

     

In Part I of this series, I explained the definition of pharmaceutical expiration dates and ‘do not use beyond’ dates, and how both are determined.

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Additionally, I reviewed information from the Shelf Life Extension Program (SLEP) database, which led to a temporary Emergency Use Authorization in 2009, permitting the use of certain Tamiflu products (to treat H1N1 influenza) for up to an additional five years beyond the imprinted expiration date. (See Part I of this series for more information. )

Part II will examine the data regarding use of common antibiotics beyond their expiration dates.

The following is excerpted from my upcoming book, Armageddon Medicine.

Does a can of tuna go bad overnight? What about a bottle of medicine? Common sense suggests the answer is no, but is there any evidence?

The primary source of information regarding the prolonged stability of medications comes from the Shelf Life Extension Program database. Rather than discard millions of dollars worth of expired drugs stockpiled for emergency use, the U.S. federal government tested representative lots of selected medications for extended stability. These stockpiled drugs are aimed at emergency use for injuries and infections rather than chronic diseases such as diabetes, heart disease, and asthma. The most useful data for the layman is related to drugs to combat bacterial and viral infections.

Of the antibiotics tested, all passed assays for stability, potency, and appearance for at least a year beyond the original expiration date.

Of the lots tested, the following had their expiration date extended by the number of months indicated.

Medication Name Dosage Form Average extension in months (range) Amoxicillin sodium Tablets 23 (22–23) Ampicillin Capsules 49 (22–64) Cephalexin Capsules 57 (28–135) Ciprofloxacin Tablets 55 (12–142) Doxycycline Hyclate Capsules 50 (37–66) Erythromycin lactobionate Powder 60 (38–83) Sulfisoxasole Tablets 56 (45–68) Tetracycline HCl Capsules 50 (17–133) Silver sulfadiazine Cream 57 (28–104)

A summary of the Shelf Life Extension Prorgarm (SLEP) data is available in The Journal of Pharmaceutical Sciences, Vol. 95, No. 7, July 2006.

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October 29, 2010