The FDA has approved a new diabetes medication called Farxiga (Dapagliflozin). It lowers blood sugar, which is certainly beneficial for type 2 diabetes.
Farxiga comes in the form of a tablet. It is classified as a sodium glucose co-transporter 2 inhibitor which blocks the reabsorption of glucose by the kidney. This causes an increase in the excretion of glucose in the urine so lowers the level of glucose in the blood.
Farxiga is to be taken once a day. It should be combined with healthy diet and exercise which help to improve glycemic control for adults with type 2 diabetes.
The starting dose should be 5 mg once a day, in the morning with or without food. If a patient proves able to tolerate the drug, and needs more glycemic control, the dose can go up to 10 mg once a day.
Its most common side effects are genital fungal infections and urinary tract infections. More serious possible side effects are increased renal damage, even renal failure in patients who already have moderate to severe kidney damage. Many diabetes already have compromised renal function.
Farxiga has been linked with hypotension. This is especially true for older patients, or those with impaired kidney function, and those on diuretics.
The drug is not recommended for patients with type 1 diabetes. It should not be taken by patients with increased ketones in urine or blood. It is contraindicated for those with moderate or severe kidney impairment, end-stage renal disease or patients who are on dialysis.
Those who have active bladder cancer should not take Farxiga. Patients in studies for the FDA were found to be five times more likely to develop bladder cancer than patients taking another diabetes drug.
FDA scientists cautioned that the drug could stimulate bladder cancer in patients who were already at risk.
Patients taking Farxiga were found to be more than twice as likely to get breast cancer as those not taking it. It's uncertain whether there is a direct correlation.
In 2012, the drug was denied approval. The FDA did not think that enough information about benefits and risks had been given.
In December of 2013, an FDA advisory panel approved Farxiga, saying that the drug's cardiovascular risk profile was acceptable.
In spite of concerns from FDA scientists and other experts, in spite of concerns of the advisory committee, recommendation of the drug went forward, with the proviso that testing of the drug should continue after it was approved.
Drugmakers Bristol-Myers Squibb and AstraZeneca will be required to perform post-market studies.
These will include an animal study of drug-induced urinary flow, a bladder cancer risk trial, a bladder tumor promotion, a cardiovascular outcomes trial in patients who have baseline cardiovascular disease risks, two trials for risks in pediatric patients, an enhanced pharmocovigilance program studying liver abnormalities, and pregnancy outcomes.
Diana Zuckerman, president of the National Research Center for Women & Families, was in attendance at the December, 2013 meeting. She said that there were too many unanswered questions to proceed.
Zuckerman was a researcher at Harvard, a health policy expert in Congress, and served on the faculty of Vassar and Yale. She was a senior policy advisor in the Clinton White House. She has authored five books as well as several chapters for other books, and dozens of articles in academic and medical journals.
She has serious concerns about Farxiga. In a Feb. 4, 2014 article she wrote, "The agency just approved a new diabetes medication that doesn’t noticeably improve health but may in fact cause cancer."
Zuckerman went on to say, "It’s too early to say whether this will be the worst decision the FDA makes in 2014. Maybe the diabetes patients who take it will be lucky and not be harmed by the drug. Or maybe only a few patients will develop cancer or kidney failure as a result of taking it. Or the FDA scientists who expressed their concerns could be wrong, and I could have made a mistake when I agreed with them. But regardless of what happens with this drug, it still would be a bad decision to allow the sale of a drug with such serious (potentially fatal) unanswered questions."
Sources:
The Worst New Drug of 2014. Mariasfarmcountrykitchen.com. Retrieved Feb. 6, 2014.
http://www.mariasfarmcountrykitchen.com/the-worst-new-drug-of-2014
FDA Approves New Diabetes Drug. Medpagetoday.com. Retrieved Feb. 6, 2014.
http://www.medpagetoday.com/Endocrinology/Diabetes/43703
FDA Approves Farxiga, AstraZeneca and Bristol-Myers Squib New Type 2 Diabetes Treatment. Asweetlife.org. Retrieved Feb. 6, 2014.
http://asweetlife.org/news/fda-approves-farxiga-astrazeneca-and-bristol-...
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Reviewed February 10, 2014
by Michele Blacksberg RN