ashp_keith_with_poster-532765-edited.jpgReceiving 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.

In addition to adding the side effect to the drugs’ labels, FDA has also mandated post-marketing studies that will require manufacturers to analyze spontaneous post-marketing reports of ketoacidosis in patients using SGLT2 inhibitors.

Our excitement is generated by knowing that with 74% of alerts issued by FDA, our clients already knew it was coming.  Advera Health, first identified Ketoacidosis as a serious adverse event linked to the SGLT2s over a year prior to the initial FDA announcement in May, providing our clients with a unique competitive advantage that affords them with the opportunity to implement strategies to mitigate patient and financial risk. This advanced signal once again, validates the RxSignal predictive algorithm.

The critical nature of post-marketing data to identify safety concerns is clearly highlighted by FDA's action. It also underscores the need to quantify the downstream medical costs of drug side effects when making drug utilization decisions. Advera Health’s RxCost enables us to calculate that ketoacidosis accounts for nearly $2.5 million in reported costs for this side effect alone. A side effect that was not even on the drug's label a week ago. A side effect that those decision makers who have not yet adopted the use of post-marketing data could not have known about when making drug decisions.

A side effect that our clients knew all about in early 2014.

Coincidently, this week we presented independent research we have conducted on the SGLT2, DPP-4, and GLP-1 diabetes medications via a poster presentation at the ASHP Midyear conference in New Orleans. The interest from the Health System Pharmacist community is, as it always has been, very high. The poster outlines not only serious, unknown adverse events that are not being communicated to decision makers, but also uses RxCost to quantify what the impact of those events (and the ones that are known) are on a System’s bottom line.

Using these data in early 2014 when the first RxSignal was activated for the SGLT2s and ketoacidosis would have allowed healthcare decision makers to reduce the cost burden of these drugs through more informed decision making and could have prevented harm and improved patient outcomes.

We welcome you to take a look at the ASHP poster and contact us with any questions.

Presented at ASHP Midyear 2015: Direct Medical Costs From Post-Marketing Adverse Drug Reactions: Focus on GLP-1, DPP-4, & SGLT2 Type 2 Diabetes Medications [Free Download - No Form Required]

Topics: FDA, Drug / Indication Information

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.