Approval
On December 19, 2017, the FDA approved Merck & Co. and Pfizer’s new diabetes drug, Steglatro, and its two combination versions, Steglujan and Segluromet. These drugs are classified as sodium/glucose cotransporter 2 (SGLT2) inhibitors, and will be available this coming January.
Steglatro consists of ertugliflozin, while Steglujan combines it with Januvia (sitagliptin), and Segluromet combines it with metformin.
According to the drug label (for Steglatro, accessed 12/28/17), these drugs are “indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
A recent MedScape article provides the following information:
The new drug applications were accepted for review in March 2017 and were supported by studies from the VERTIS clinical development program for ertugliflozin, which consists of nine phase 3 trials in approximately 12,600 adults with type 2 diabetes.
Results from VERTIS MONO, VERTIS FACTORIAL, and VERTIS SITA2 were presented at medical congresses in 2016, and findings from VERTIS SU and VERTIS SITA2 were presented at the European Association for the Study of Diabetes (EASD) 2017 Annual Meeting in September 2017.
New Drug, Same Side Effects
Like other SGLT2 inhibitors — such as Invokana, Farxiga, Jardiance, Synjardy, Glyxambi, and Qtern — these new type 2 diabetes drugs also carry warnings of the following serious side effects:
- Ketoacidosis
- Acute Kidney Injury
- Impairment in Renal Function
There is also a lower-limb amputation warning for Steglatro and its counterparts. This is particularly interesting, given that Invokana is the only other SGLT2 inhibitor at this time whose drug label also mentions this warning.
However, unlike Invokana, Steglatro (and its combinations) do not include amputations in a so-called “Black Box” warning. This is probably due to the label’s claim that “A causal association between STEGLATRO and lower limb amputation has not been definitively established.”
Perhaps the drug companies responsible for Steglatro, Steglujan, and Segluromet added this warning so as to protect themselves from lawsuits in the event that a causal relationship between these drugs and lower-limb amputations is definitively established in the future.
Class Effects
While other SGLT2 inhibitors are quick to distance themselves from the lower-limb amputation side effect, further clinical data may prove it to be a class effect.
The first three side effects mentioned above have been shown to apply to the entire class of SGLT2 inhibitors diabetes drugs, and as such, are mentioned in every single drug label for these drugs.
We will continue to monitor the medical literature on SGLT2 inhibitors and their relationship to lower-limb amputations and other serious side effects. In the meantime, we encourage you to visit our website and complete a free case evaluation if you or someone you know has taken an SGLT2 inhibitor and suffered one of the serious side effects mentioned in this article.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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