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        New Message Board Archives >> Medications, Treatments, Therapies 2003 >> An FYI About Imitrex injections
        
(Message started by: Kasey4 on Jun 16^th, 2003, 6:35am)

Title: An FYI About Imitrex injections
Post by Kasey4 on Jun 16^th, 2003, 6:35am

I had asked back in the winter if you thought expired injections would be okay. Now I know firsthand that they are. I did 5 leftover injections last month that expired 09/01 and they worked just as well as the new ones I got.

I can't believe I considered throwing them out when I had been out of cycle for 2 1/2 years - what an idiot I would have been!

Title: Re: An FYI About Imitrex injections
Post by eyes_afire on Jun 16^th, 2003, 4:50pm

Hi Kasey4. Yeah, I'm glad you didn't throw them out as well. Imitrex expiration is a very common topic here. If you're interested, here is how I explained it in the past based on my knowledge from working with drug product stability studies:

To obtain FDA approval, drugs are tested for product stability. To get approval, the drugs have to demonstrate product stability at least up to thier expiration date. A comprehensive 3 year stability study may cost the drug company $1 million (but don't cry for the drug companies, because they make a killing in profits). Speaking from experience, most drug companies don't pursue stability studies beyond 3 years, but that doesn't necessarily mean that the product is not good for longer than that. The product may very well be good for much longer than that, but it doesn't do the drug companies much good investing that kind of money just to get a longer expiration date.

Basically the expiration date means either:

1. The drug product will lose potency once the expiration date is exceeded.

or

2. The drug company knows that the product is at least effective up to expiration date and didn't see a need to invest further simply to get a longer expiration.

Personally, I would use expired imitrex if I needed to. Most obvious down-side is that it might not be as potent. Based upon what others have reported here on this message board, I'll bet that imitrex is very stable. That's just my opinion, you may want to check the archives. Of course, you should not take imitrex unless it is under the supervision of a physician.

Certainly, I'm not advocating that you disobey your doc or take meds improperly ;), I'm just offering my perspective.

Drug Product Stability study protocols are governed and influenced by the US Code of Federal Regulations Part 211 subpart G and the International Conference on Harmonization. For more info:

http://www.fda.gov/cder/dmpq/cgmpregs.htm#211.137

http://www.fda.gov/cder/guidance/4282fnl.htm#P511_40316

Title: Re: An FYI About Imitrex injections
Post by Kasey4 on Jun 16^th, 2003, 6:13pm

Yep, it being ineffective was my only worry but it worked!

I did not know about the study costs relating to expiration of medicines though - thanks for the information :)