Greetings from Dr K, your War on Diabetes pharmacist. Today I’m coming to you with news of a new medication for diabetes that will now be available in the United States. If you’ve been reading our blog for awhile, you will know that I talked about a medication named Forxiga. Forxiga was the first medication in its class – it helps to lower your blood sugar levels by helping you release more glucose from your body in your urine. Well today, we learned that Forxiga will now be available in the United States, but it will be called Farxiga (to make it less confusing, I will be calling it Farxiga for the remainder of this post).
In November of 2012, Farxiga was approved for use in the European Union. The manufacturers tried to get it approved in the United States at that time, but the Food and Drug Administration (the organization that approves or denies medications for use in the United States) requested more research trials be conducted before approval. There were concerns about Farxiga being linked to the development of tumors and cancers.
In April the FDA approved a similar drug in the United States called Invokana. Invokana works the same way as Farxiga. Farxiga will join Invokana as the second in its class, known as a sodium-glucose co-transporter 2 (SGLT2) inhibitor.
The concerns about tumors and cancers with Farxiga have not completely gone away. The FDA does not recommend Farxiga for patients with active bladder cancer and states that patients with a history of bladder cancer should discuss this with their physician prior to starting Farxiga. The FDA also mentioned that patients with kidney impairment, end stage renal disease, or those on dialysis should not take Farxiga. Also, the FDA is requiring six additional post-marketing studies to be conducted by the manufacturers. They are:
- A trial to determine the cardiovascular risk of Farxiga in patients who are at high risk of developing cardiovascular disease
- A thorough assessment of bladder cancer risk in patients participating in the above study
- A study in animals to evaluate Farxiga’s effects on urinary flow and rate and bladder tumor promotion
- Two studies to evaluate the medication in pediatric patients – at what rate does the medication pass through their bodies and how, is it effective, and is it safe?
- An extensive program to monitor any reports of liver problems and how Farxiga affects pregnancy
The most common side effects seen with Farxiga in trials are genital fungal infections and urinary tract infections.
This is big news for American type 2 diabetics. Since this is a new drug, we do not have the extensive history in regards to safety and effectiveness that we do in our standards like metformin and insulin. But, for patients who are not at their A1c goal and would like to try another option, Farxiga might be a good choice. As always, discuss all medication changes with your local physician.
If you want to read the official statement from the FDA, it can be found here.