In May 2015, the FDA issued a Safety Announcement warning that six Type-2 diabetes drugs – all SGLT2 inhibitors – may be causing serious problems in patients. Sodium-glucose cotransporter-2 (SGLT2) inhibitors are prescribed to patients with Type-2 diabetes. These drugs work by blocking the ability of the kidneys to reabsorb glucose. Diabetes drugs such as SGLT2 inhibitors carry a risk of complications. However, these medications are now being linked to patients being diagnosed with diabetic ketoacidosis, kidney damage, renal failure, stroke and heart attack.
- Invokana (Invokamet) (Canagliflozin)
- Jardiance (Empagliflozin)
- Farxiga (Dapagliflozin)
- Invokamet (Canagliflozin and Metformin)
- Glyxambi (Empagliflozin and Linagliptin)
- Xigduo XR (Dapagliflozin and Metformin extended-release)
The first SGLT2 inhibitor to be cleared for use in the U.S. was Invokana in 2012. SGLT2 inhibitors work differently than other diabetes medications as they don’t actually affect insulin levels. Instead, they limit the reabsorption of glucose in the kidneys to help reduce the amount of sugar in the bloodstream.
Soon thereafter, in January 2014, the FDA approved Farxiga to treat Type-2 diabetes in adults when used in conjunction with diet and exercise. They allowed the drug into the marketplace with one caveat. Manufacturers Bristol-Myers Squibb and AstraZeneca had to conduct six post-market clinical studies, including a cardiovascular outcomes trial and a bladder cancer trial. The companies were also required to do studies on liver abnormalities, pediatric risks, urinary flow and pregnancy risks.
Although finally approved to treat Type-2 diabetes in August 2014, Jardiance (empagliflozin) was originally denied FDA approval when initially submitted in March 2013. At that time, the FDA issued a letter referencing deficiencies at a Boehringer Ingelheim facility where empagliflozin would be manufactured and stated they needed to be resolved before the approval of the application. The FDA did not ask Boehringer to complete any new clinical trials to support the approval of the application. After less than one year on the market, the FDA issued a warning about the potential link between Jardiance and ketoacidosis.
The approval of Invokamet, manufactured by Janssen Pharmaceuticals, also took place in August 2014. Invokamet is a combination of Invokana and Metformin hydrochloride, an older generation diabetes medication. It is intended to treat Type-2 diabetes in adults whose blood glucose is not adequately controlled by Metformin or Invokana alone.
SGLT2 Inhibitors have been linked to the following severe issues:
- Heart Attack
- Diabetic ketoacidosis (DKA) – life-threatening condition that develops when the cells in the body are unable to get the sugar they need for energy and involves the accumulation of high levels of acid in the blood
- Kidney failure
The FDA continues to investigate the safety issues and will determine whether changes are needed in the prescribing information for the SGLT2 class of drugs. They are advising patients to be on the lookout for any signs of ketoacidosis (DKA), cardiac complications or kidney failure. Signs include shortness of breath, fatigue, nausea and abdominal pain.
If you or a loved one has taken an SGLT2 inhibitor and are now suffering or have suffered from kidney damage, renal failure, diabetic ketoacidosis, stroke or heart attack, contact the SGLT2 inhibitor attorneys at Martin, Harding & Mazzotti, LLP at 1800LAW1010 (1.800.529.1010) today. We’ll review your case to determine the best course of action to get the justice and compensation you may be entitled to.
Our legal team is available to serve you from multiple offices across New York State and Vermont, including: Albany, NY, Saratoga, NY, Schenectady, NY, White Plains, NY, Rochester, NY, Plattsburgh, NY, Utica, NY, Buffalo, NY, New York City, NY, Manchester, VT and Burlington, VT. Call us any time, 24/7 if you’ve been wrongfully injured, disabled or have lasting medical issues as a result of prescribed type-2 diabetes drugs such as: Invokana, Jardiance, Farxiga, Invokamet, Glyxambi or Xigduo XR.