Earlier this month FDA approved Farxiga (dapaglifozin), a new tablet from Bristol-Meyers Squibb Co. and AstraZeneca Pharmaceuticals to help improve glycemic control in adults with type 2 diabetes. Because an increased number of bladder cancers were diagnosed among Farxiga users in clinical trials, Farxiga is not recommended for patients with active bladder cancer. Side effects of Farxiga include genital mycotic (fungal) infections, urinary tract infections, and dehydration which can lead to a drop in blood pressure (hypotension), dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to these risks. The FDA is requiring 6 post-market studies of Farxiga:
[1] FDA News Release, "FDA approves Farxiga to treat type 2 diabetes" (Jan. 8, 2014).
- a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline risk of cardiovascular disease;
- a double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT;
- an animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents;
- two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients; and
- an enhanced pharmacovigilance program to monitor reports of liver abnormalities and pregnancy outcomes.
[1] FDA News Release, "FDA approves Farxiga to treat type 2 diabetes" (Jan. 8, 2014).
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