The quote sounds like something I would have typed--but I agree with, in any case.

I'm not in a position to get into the science of the question but I've had two wheels in the industry tell me that the expiration date is required by the Feds but that the mfg. are ambivalent about the validity of the requirement.

I just searched PubMed on the issue and was struck by two issues: A. how very few abstracts popped up, B. how dated most were, C. how many hits give a citation but didn't allow one to get an abstract. (I try to avoid conspiratorial thinking but this is curious!)

But this is the only hit which is broadly useful, in my judgment:

J Pharm Sci. 2006 Jul;95(7):1549-60.

Stability profiles of drug products extended beyond labeled expiration dates.
Lyon RC, Taylor JS, Porter DA, Prasanna HR, Hussain AS.

Division of Product Quality Research, Center for Drug Evaluation and Research, Food and Drug Administration, HFD-941, White Oak, Life Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002, USA. robbe.lyon@fda.hhs.gov

Abstract
The American Medical Association has questioned whether expiration dating markedly underestimates the actual shelf life of drug products. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. This program probably contains the most extensive source of pharmaceutical stability data extant. This report summarizes extended stability profiles for 122 different drug products (3,005 different lots). The drug products were categorized into five groups based on incidence of initial extension failures and termination failures (extended lot eventually failed upon re-testing). Based on testing and stability assessment, 88% of the lots were extended at least 1 year beyond their original expiration date for an average extension of 66 months, but the additional stability period was highly variable. The SLEP data supports the assertion that many drug products, if properly stored, can be extended past the expiration date. Due to the lot-to-lot variability, the stability and quality of extended drug products can only be assured by periodic testing and systematic evaluation of each lot.

PMID: 16721796 [PubMed

"Keep trying your old Imitrex. Unless it has been storted in bad conditions , the expiration dates on meds are not of any merit."

Many many of us - from personal experience - have actually found the above quote to be very true regarding imitrex injectible.


Chris H wrote on Oct 30^th, 2010 at 8:54am:


Yes, the manufacturer....who profits from people throwing away their exhorbitantly priced, still effective meds and shelling out yet more huge bucks to replace them.

My Imitrex injectiables are expired.  I am only allowed a cetain amount each month so I stock up when I am not in a cluster.  I don't over due it, I just get what I think I need for next cluster.  I asked my pharmacist if I can use these after the expiration date.  He said they are good 3-6 months after the expiration date.  Anyone else ask their pharmacist what they think?

~Becky

Brew, Do you really think the pharmacist is answering important questions like this based on the business he or she works for selling more drugs? They're likely to give you an answer that's on the safe side to protect themselves, granted, but in general, I think the pharmacist is answering based on what they know to be safe. These are individuals, just like you and me and not part of some big conspiracy to get rich from the needy. -Chris

I definitely agree with you there about it being a CYA world. Anyone in the drug business is going to give you the "safe" answer, at least anyone who can be sued if they're wrong. There are enough lawsuits out there where people did have adverse events even when they used drug off label or after expiration. Generally the label and expiration protect them in court, not the patient.

About 10 years ago I worked in the regulatory area at Merck that was responsible for adverse event reporting to the FDA. You wouldn't believe some of the problems that are reported. The FDA is fairly quick to attach a causal relationship when someone dies or is seriously injured. They have nothing to gain from that other than patient safety, and not being embarrassed with another Phen-Phen.

Holding onto drugs for years after expiration, in my humble opinion, having been in the industry for over 20 years, is taking a lot of unnecessary risk. If you're using the SLEP study that was conducted by the military as a guideline, don't. Those were highly stable drugs in a highly controlled environment. They are not representative of the lion's share of drug on the market or any that is kept in your bathroom.

-Chris

There are certain meds - and I'm sure Chris could expound on this - that are FAR more sensitive to environmental upheaval. Insulin is one of them. I inject myself once a week with a biologic called Enbrel, and that stuff will "go bad" in a matter of hours if it's not kept refrigerated.

Imitrex doesn't fall into that category - many here have used it literally YEARS beyond it's expiration, with a few reporting no change in effectiveness and a few reporting that it didn't work quite as well.