FDA still have doubts over safety of dapagliflozin diabetes drug

America’s Food and Drug Administration (FDA) still have doubts over granting approval for the type 2 diabetes drug dapagliflozin which is marketed under the brand name Forxiga.
The drug, which has been granted approval in the UK, has failed to get the go ahead from America’s advisory body over safety concerns. Chief amongst these concerns are that in phase 3 trials, 10 patients taking Forxiga developed bladder cancer, compared to 1 in the control group.
The other health risk that could hold back dapagliflozin’s US approval is a worry over the number of cases of serious liver toxicity that was found amongst the trial participants that took dapagliflozin. AstraZeneca and Bristol-Myers Squibb, the makers of the drug, have presented new data to put evidence across that the drug treatment does not raise bladder tumour risks, however, the new has been limited to animal studies.
Dapagliflozin is in a new class of drugs, SGLT2 inhibitors, of which one of these drugs, canagliflozin (trade name Invokana) has been approved by the FDA. SGLT2 inhibtors work by increasing the amount of glucose removed from the blood by the kidneys and the glucose is then excreted out of the body via the bladder.
British patients on Forxiga may wish to keep in touch with the US approval in the US as the drug is new and whilst the medication has been granted approval by the NHS and NHS Scotland, longer term effects of the drug over several years in humans is, as yet, still unknown.