FDA issues warnings on Janssen, AstraZeneca diabetes drugs
pharmafile | June 15, 2016 | News story | Research and Development, Sales and Marketing |Â Â AstraZeneca, FDA, Janssen, farxiga, invokanaÂ
The US Food and Drug Administration has issued a warning of the risk of acute kidney injury for the type-2 diabetes medicines Invokana (canagliflozin) and Farxiga (dapagliflozin), made by Janssen and AstraZeneca respectively.
This latest warning strengthens the existing guidance on these drugs. Invokana and Farxiga belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT-2) inhibitors which, by lowering blood sugar, can cause the kidneys to remove sugar through the body through urine.
From March 2013 to October 2015, the FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalisation and dialysis, relating to use of these two drugs. The regulator also points out that there may be many cases which did not reach their attention.
Invokana and Farxiga reached sales of around $1.31 billion and $492 million, respectively, last year. With other SGLT-2 inhibitor, Jardiance, achieving success in cardiovascular indications in clinical trials, both Janssen and AstraZeneca have been looking at their own drugs in such indications. Jardiance was not included in the latest FDA guidance.
With this warning, the FDA recommends that health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on Invokana and Farxiga. These may include chronic kidney insufficiency, congestive heart failure, and taking other medications such as diuretics, ACE inhibitors, ARBs and NSAIDs.
Sean Murray
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
