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FDA Issues New Warning for Invokana Diabetes Drugs

The U.S. Food and Drug Administration (FDA) recently issued a new safety alert regarding the increased risk of Fournier’s gangrene among diabetes patients using Invokana and other drugs in the same class. Fournier’s gangrene is considered to be a rare, but very serious complication of SGLT2 inhibitors. This condition is... Read more »

Federal Farxiga Lawsuits Consolidated in NY

The makers of Farxiga, Bristol-Myers Squibb and AstraZeneca, are facing at least 18 product liability lawsuits filed in federal courts. These have now been centralized into a multidistrict litigation (MDL) pursuant to an order issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued on April 6, 2017. The... Read more »

Report Highlights Risks of Newer Diabetes Drugs

Metabolic acidosis is a risk associated with Invokana that was recently highlighted in a report by the Institute for Safe Medical Practices (ISMP). Invokana is one of the drugs recently touted for its ability to manage type 2 diabetes, but potential side effects have raised concerns and led to a... Read more »

FDA Issues Warning about SGLT2 inhibitor Side Effects

The FDA has issued a safety communication involving potentially dangerous side effects associated with a category of type 2 diabetes drugs known as SGLT2 inhibitors. The agency has warned that use of the drug could lead to ketoacidosis, a serious condition often requiring emergency medical care. Urinary tract infections or... Read more »

Plaintiff Blames Invokana for Severe Kidney Damage

Plaintiff Gene Schurman, a resident of Illinois, claims he suffered severe kidney damage after taking the diabetes drug Invokana under the direction of his doctor. He is now suing Janssen Pharmaceuticals, Johnson & Johnson and Mitsubishi Tanabe Pharma Corporation on claims of failure to warn, product liability, design defect, fraud,... Read more »

FDA Declines Approval of New Combination Diabetes Drug

London-based AstraZeneca failed to obtain FDA approval for a proposed diabetes drug that combines two different medications, saxagliptin and dapagliflozin. In October 2015, the FDA issued a complete response letter to the pharmaceutical giant’s application. The agency requested additional clinical research on the proposed combination drug. AstraZeneca recently released statements... Read more »