LYMEPOLICYWONK: Expired Drugs—Are they Effective, Safe?
This is a little off topic for my blog, but something that is of high interest to patients. Patients ask all the time about the effectiveness and safety of “expired” drugs. A recent article that appeared in the Medical Letter examines the issue in detail. The article notes that generally manufacture expiration dates merely reflect the fact that the drug is “stable” at that point, they do not reflect when the drug becomes unstable. The conclusion of the article indicates that outdated drugs may be effective and safe for at least 5 years after the expiration. Notable exceptions include liquid suspensions and epinephrine in Epipen, which are not stable over time. The article also notes the following: " There are no published reports of human toxicity due to ingestion, injection or topical application of current drug formulations after their expiration date. Renal tubular damage has been reported after use of degraded tetracycline in a formulation that is no longer available (REF 2)." Other sources contain warnings about expired doxycycline, which may (or may not) be based on this outdated tetracycline warning, but patients may want to check with their doctors when using expired doxycycline to be on the safe side.
The article concludes:
When no suitable alternative is available, outdated drugs may be effective, and there is no indication that they are not safe. There are no reports of toxicity from degradation products of currently available drugs. How much of their potency they retain varies with the drug, the lot and the storage conditions, especially humidity, but many drugs stored under reasonable conditions in their original unopened containers retain 90% of their potency for at least 5 years after the expiration date on the label, and sometimes much longer.
A copy of the article is here.
You can follow other Lyme policy posts at lymepolicywonk.org. You can contact Lorraine Johnson, JD, MBA at firstname.lastname@example.org.