I 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.