Every June, on the heels of the ASCO annual conference, comes the American Diabetes Association (ADA) annual conference, with a data deluge that is difficult for even the most diligent industry watchers to keep up with. At time of writing, it is only midday on Tuesday and there are already huge headlines from the conference.
Last week we officially launched our revamped platform Evidex, which now includes easy-to-navigate evidence from both clinical trial data and real-world adverse event reports. To give you an idea of how simple it is to complete a thorough drug review in this platform, I'll go through a step-by-step overview of how to compare multiple diabetes meds.
Receiving Medwatch emails from FDA are an exciting thing around Advera Health. Though a bit morose, when we see that drug safety warning pop into our Inbox with FDA’s logo, we must admit to getting a little giddy. On Friday, FDA issued their second safety communication around the SGLT2 class of diabetes drugs and a serious (and very costly) side effect of those drugs, a condition called ketoacidosis. Ketoacidosis is a very serious condition that can lead to diabetic coma or even death. In this communication it was revealed that the FDA finally added ketoacidosis as an adverse event to the drugs’ labels, following an initial communication in May that they were evaluating the risk.
Last week I wrote about constructing a framework for comparable safety research (CSR) to compliment the work being done with comparable effectiveness research (CER). Careful and continuous post-approval monitoring is vital to the evaluation of a drug’s safety profile, and with the proper framework and tools in place can be done quite easily.
A great example of what a CSR framework looks like can be found in our recent special report, The Comparative Safety of Type 2 Diabetes Medications.