Invokana is a drug created for type 2 diabetes patients. It is in a new class of Type 2 diabetes medications called sodium-glucose cotransporter 2 (SGLT2) inhibitors. Instead of making the liver produce more insulin, Invokana and SGLT2s control blood sugar by causing excess sugar to leave the body in urine. Although there have been major side effects of this drug, it has not been recalled yet.
Some of the serious side effects of Invokana are ketoacidosis, Leg and/or foot amputation, kidney injury or failure, lowered bone density, bone fracture risk, acute pancreatitis, blood infection and urinary tract infection.
Ketoacidosis is a result of a shortage of insulin causing the body to burn fatty acids instead. This process produces a buildup of acids in the bloodstream called ketones, eventually leading to diabetic ketoacidosis if untreated. Some symptoms of ketoacidosis are:
❏ Excessive thirst
❏ Frequent urination
❏ Nausea and vomiting
❏ Abdominal pain
❏ Weakness or fatigue
❏ Shortness of breath
❏ Fruity-scented breath
Untreated diabetic ketoacidosis can be fatal.
Increased leg and/or foot amputation was reported among Invokana users vs. diabetes patients on other medcations. Some patients had toe or partial foot amputation while other patients have had multiple amputations in both limbs.
Pooled data from 9 clinical trials revealed increased bone fractures, broken bones and bone density among Invokana users. A 2 year clinical trial showed these fractures were primarily in the hip and lower spine. Breaks occurred as early as 12 weeks after starting Invokana.
Although SGLT2 drugs have recently claimed to lower cardiovascular risk, a clinical study of patients at high risk for cardiovascular disease showed that 13 patients had a major clinical event (stroke/heart attack) within the first 30 days of taking the drug. However, only 1 patient in the placebo group had an event.
Despite the concerns, the FDA approved Invokana in March 2013. FDA approval came with the condition that the manufacturer conduct additional studies to answer some of the safety questions raised above. These additional studies of the SGLT2 type drugs will continue to show long term dangers of use. These studies should have been done prior to the drug’s approval.
Laird, Baker and Blackstock is currently evaluating cases for potential claims against the manufacturers of Invokana. If you or someone you love have experienced any of these side effects from taking the drug, Invokana, call our office or click the link below to schedule a free consultation. There is not a fee unless we recover.