New drug celebrated, side effects downplayed
When it arrived on the market in March 2013, Invokana was hailed as a breakthrough way to treat Type 2 diabetes. It lowered blood sugar by excreting the excess in urine. Until it was approved by the U.S. Food and Drug Administration (FDA), all drugs for diabetes were designed to control insulin levels in the blood.
Just as marvelous, according to TV commercials about Invokana, patients might lose weight and lower their blood pressure. Both were off label benefits not approved by the FDA. During the 4th quarter of 2014, little more than a year after it was approved, Invokana (in tandem with Invokamet) racked up $201 million in sales for Johnson & Johnson. It’s estimated that more than 29 million Americans have diabetes. The majority have Type 2 Diabetes, putting scores at risk for complications caused by Invokana and other SGLT2 drugs.
Invokana’s cardiovascular risks initially downplayed
Even as Invokana made its debut, Johnson & Johnson, the drug’s manufacturer, knew that it could pose serious cardiovascular risks. So did the U.S. Food and Drug Administration (FDA). But the federal agency did not require the drug company to list the risks on Invokana’s label. It stated that their significance was “unclear” even though clinical trials conducted before the drug was approved showed that within 30 days, it increased LDL and HDL cholesterol.
A month after the FDA approved Invokana, doctors involved in the approval process said they had mixed opinions of the drug, urging more studies to address “unanswered safety questions” - in particular Invokana’s effect on the heart. Since then, numerous lawsuits have been filed nationwide by victims who say it caused their heart problems.
Invokana causes ketoacidosis – a dangerous condition that can quickly turn fatal
In December 2015, the FDA warned that Invokana and other SGLT2 inhibitors - Jardiance, Farxiga, Invokamet, and the lesser known Glyxambi and Xigduo XR, can cause ketoacidosis. Ketoacidosis can become deadly in a few hours after symptoms appear.
Victims of Invokana and SGLT2 inhibitors can take legal action
Call Wayne Wright with confidence if Invokana or any of the other SGLT2 drugs caused you needless suffering and pain. The call is free. So is the evaluation. There is no charge for representation unless the firm recovers for you.
Wayne Wright’s success on behalf of victims was recognized by a Litigator Award in 2014. This rare honor is solely based on winnings for clients. Less than 1% of attorneys ever qualify for this award.
FDA safety communiques about SGLT2 drugs show growing concern
Doctors became suspicious of Invokana when patients with Type 2 Diabetes began developing ketoacidosis. The FDA”…identified 20 cases of ketoacidosis …between March 2013 and June 2014…,” the first year Invokana was on the market. Ketoacidosis is rare in Type 2 Diabetics.
- In May 2015, the FDA issued a “drug safety communication” warning that SGLT2 drugs for type 2 Diabetes could lead to ketoacidosis and that its investigation of the drugs was continuing.
- In December 2015, the FDA ordered drug companies to add warnings about ketoacidosis and serious urinary tract infections to the labels of all SGLT2 drugs, stating that both “…can result in hospitalization.”
- In May 2016, the FDA issued a “drug safety communication” citing trial results that found an increased risk of leg and foot amputation associated with Invokana and Invokamet.
Symptoms of Ketoacidosis
According to the American Diabetes Association, ketoacidosis usually develops slowly. When vomiting occurs after early symptoms have appeared, ketoacidosis can quickly become life-threatening. It develops when the body begins to burn fat for energy because it does not have enough insulin to use glucose, the body’s normal energy source. That produces ketones. Ketones are poisonous.
Early symptoms of ketoacidosis:
- Thirst or a very dry mouth
- Frequent urination
- High blood sugar levels
- High ketone levels in the urine
Later symptoms of ketoacidosis:
- Constantly feeling tired
- Dry or flushed skin
- Nausea, vomiting, abdominal pain
- Difficulty breathing
- Fruity odor on breath
- A hard time paying attention, or confusion
Other potential side effects of SGLT2 drugs
- Genital and urinary tract infections
- Bladder cancer (testing is underway)
- Breast cancer (testing is underway)
- Kidney failure
- U.S. Food and Drug Administration (FDA)
- American Diabetes Association
- The New York Times
- Public Citizen
- Endocrine Web
- Medline Plus
- Fierce Pharma
- MedPage Today