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On October 24, 2014 · Add Comment Earlier in 2014, the FDA approved a new drug named Farxiga used to treat symptoms of type 2 diabetes. Reports from the FDA show that the most common side effects of Farxiga are urinary tract infections and genital fungal infections. Studies done by the company and provided to the FDA also show that patients taking Farxiga were more than twice as likely to develop breast cancer as those not taking the drug. The FDA rejected the drug Farxiga two years ago over these cancer concerns, but reversed it’s decision and approved the drug in early 2014.
The diabetes drug Actos also increased the risk of bladder cancer, and several large jury awards have been handed down due to these risks.
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Canaglifozin, the generic name for the new medication, works by blocking the action of SGLT, which allows the blood sugar circulating in the blood to remain in the blood stream during filtration by the kidneys.
Invokana received approval after nine clinical trials involving more than 10,000 participants where the drug demonstrated improvement in both fasting blood glucose levels and hemoglobin A1C levels.
Johnson & Johnson is currently seeking approval for the new medication in Europe, where it would become the second such drug in its class to dapagliflozin, a Bristol-Myers Squibb and AstraZeneca product that was rejected approval in the United States due to safety concerns.


Sales totaling $111 million in 2013 and up to $667 million by 2016 have been predicted by Lawrence Biegelsen of Wells Fargo. The studies will evaluate heart-related outcomes, serious cases of pancreatitis, any malignancies that develop, severe allergic reactions, liver abnormalities, adverse pregnancy outcomes, bone safety, photosensitivity reactions and two pediatric studies. The Journal of the American Medical Association’s Internal Medicine reported results of a study that revealed baby boomers have a higher risk for chronic diseases, including diabetes, than do their parents despite the advances of health care over the lifespan of the boomers.
Health regulators caution that diabetic patients taking this class of sodium-glucose cotransporter-2 (SGLT2) inhibitors may be at risk for extremely high levels of blood acids – a condition known as ketoacidosis – that could require hospitalization.The diabetes medications have been widely prescribed because in addition to regulating blood glucose levels, they also encourage lower blood pressure and better weight management.
The new drug was designed to reduce medical problems such as kidney damage and heart disease, but studies done on behalf of the FDA show there is no evidence that it actually improves health.
More serious side effects are shown to be renal failure in patients who have moderate or severe kidney damage, as many diabetics do.
Attorneys at Aylstock, Witkin, Kreis and Overtholtz were part of the trial team that recently won a $9 billion dollar verdict against the manufacturer of Actos, the seventh largest jury verdict in U.S. Food and Drug Administration approved the first of a new type of medication to treat type 2 diabetes. This medication inhibits that normal process, allowing the kidneys to instead filter out excess blood glucose for excretion in the urine the U.S. Fasting blood glucose lab testing measures the about of sugar circulating in the blood that is representative of current blood glucose levels; hemoglobin A1c lab testing provides an average of circulating sugar in the blood over a period of three months.
FDA has required that Johnson & Johnson conduct five post-marketing studies for canaglifozin due to findings that occurred during the initial nice clinical trials, but whose incidence was deemed as not significant to the approval process by the federal agency. The results of these studies will aid in determination of whether the medication continues to fall within safety standards and what warnings or precautions should be observed with its use.


Some of the older diabetes drugs could lead to weight gain, a problem considering obesity is one of the main causes of the condition.The oral medications, which are FDA-approved to treat adult type II diabetes, function by triggering blood glucose to be secreted in the urine.
More alarming are the FDA studies that show a five times greater risk of developing bladder cancer than patients who took an older diabetes drug.
Nearly 26 million people have diabetes in the United States alone, and some 347 million people have the chronic disease worldwide, with type 2 diabetes being the most common form of the condition.
Both are tests that health care providers use as parameters to diagnose and treat diabetes. FDA scientists concluded that the drug may stimulate bladder cancer in patients already at risk. Healthcare providers can then evaluate patients for the presence of high acid blood levels and advise on whether SGLT2 inhibitors should be immediately discontinued.Between March 2013 and June 2014 the FDA’s Adverse Event Reporting System database logged 20 incidents of acidosis reported as diabetic ketoacidosis (DKA) or ketosis in patients who were taking Farxiga, Invokana or Jardiance. Health regulators have continued to receive adverse event reports regarding SGLT2 inhibitors and diabetic ketoacidosis since June of 2014.DKA is a form of acidosis that is typically associated with type 1 diabetes and patients with dangerously high blood sugar levels. This website is sponsored by Eisbrouch Marsh, LLC, a national law firm with principal offices located at 50 Main Street Hackensack, NJ 07601.



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