Apidra Shortage

Apidra pens and vialsI first wrote about the Apidra SoloSTAR shortage back in September. Originally, Sanofi Aventis said that the pens would be available the first quarter of this year.  On March 2nd, I wrote about drug shortages and stated that it was coming up on the end of the first quarter and there was no update as to what was going on with the Apidra pens.

I keep getting a lot of searches related to the Apidra pen shortage so yesterday I looked to see if there was any new information out there.  Sanofi did change their statement to state that they now expect to achieve normal supply levels by the second quarter of 2012:

Important pen information: Update on the temporary shortage of the
Apidra® SoloSTAR® (insulin glulisine [rDNA origin] injection) pen

This update provides the latest estimated timing for the reintroduction of Apidra® SoloSTAR® pens in the United States.

The current shortage of Apidra® SoloSTAR® pens is due to a technical incident that occurred at the Sanofi manufacturing site in Frankfurt, Germany, which has led to a temporary interruption in production. In compliance with Good Manufacturing Practices, Sanofi is currently making every effort to resolve the issue. Following stringent quality tests, we expect to achieve normal supply levels by the second quarter of 2012.

All Apidra® SoloSTAR® product currently available is safe to use. No other Sanofi insulin products, eg, Lantus® (insulin glargine [rDNA origin] injection) are affected.

You can read the full statement on the Sanofi Aventis website here.

They only changed a few words on the notice since their original September notice.  They are still using the term “temporary interruption” and that “temporary interruption” has now lasted almost six months.  They don’t state if supplies are starting to trickle in that patients might have a chance of getting some Apidra.  When they say that they “expect to achieve normal supply levels,” that sounds like some insulin is coming out of the plant but those exact words were also used in their first statement.  Unfortunately, I have a feeling I will be writing this same article again in June.  I really hope Sanofi proves me wrong on that one.

6 thoughts on “Apidra Shortage

  1. To be honest, the end of the first quarter and “by the second quarter” virtually mean the same thing. It’s March 31st or April 1st. But seeing how this seems to be playing out just like Abbott’s CGM, I understand how one can be skeptical.

    I think the supply interruption has always affected the US only. I suspect this means that the manufacturing plant somehow fell out of compliance with the FDA (but not other countries’ equivalents), and to recertify this plant, or to move to a different production facility, would require a lengthy FDA re-approval process. Again, just my personal theory, based on suspicion and absolutely no research.

    • Scott, to me the second quarter can be from April 1st to June 30th. They said “by the first quarter” back in September of last year. I was hoping then that it would be in January as opposed to March and now I am looking at anytime between April and June, if we are lucky.

      Although your thoughts are only suspicion, it is a good suspicion. I know with the Abbott stuff, the FDA was pretty closed lipped. I got chastised for saying online that the FDA had to be involved with that stuff, but it was actually an Abbott employee brought up the FDA to me on the phone. Several of us even called the FDA but the FDA would not tell us anything. I got caught up in that mess and you are right, it is hard not to be skeptical! I have also been thru another drug shortage that took a lot longer than what the company claimed it would take.

      In fairness to Sanofi, I have also been involved in jobs that you uncover all kinds of problems that you did not know about when you walked in the door. If you don’t know about those problems when you give an estimate of how long the job will take, then it is hard to give an accurate estimate. I just wish that they would be more forthcoming about what is going on. It would be a lot easier to have some faith in them!

  2. Thank you for letting me & my readers know that it is fully available in the UK Gillian. That leaves some hope for the US people! My doctor gave me a bunch of his sample pens and I am just about out of my stock.

  3. In the UK it is fully available I have been reliably informed. Hopefully the US will have your stocks up and running soonest.

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