The U.S. Food and Drug Administration (The FDA) issued a Black Box Warning
regarding Invokana® in May of 2017. This warning was sent to physicians
and the medical community to address two recently published, independent
studies indicating that patients prescribed the Type 2 Diabetes drug,
Invokana® (also Invokamet® and Invokamet XR®) had two times
the likelihood of needing toe, foot or leg amputation as compared to patients
who took a placebo drug.
The results of these studies (named CANVAS and CANVAS-R) were discussed
at the 2017 American Diabetes Association conference. While on the positive
side, these Invokana® users were 14%
LESS likely to experience a cardiovascular event, the risk of amputation doubled.
Additionally, in one of the studies, users experienced a higher rate of
bone fractures. As a result, patients taking Invokana® should contact
their doctors if they develop pain or tenderness, sores or ulcers or infections
in their legs or feet. Patients should not discontinue their medications
until speaking with a doctor.
This warning follows a previous 2015 FDA warning on Invokana® that
came after the FDA’s database identified 20 cases of ketoacidosis
and kidney damage requiring hospitalization in the first 14 months of
Invokana® being introduced. Additionally, there were over 450 adverse
events reported for Invokana® in its first year on the market. The
serious side effects linked to Invokana® include:
- Kidney failure
- Kidney stones
- Kidney damage
- Diabetic foot/leg ulcers (possibly requiring amputation)
- Urinary tract infections
- Fluid/electrolyte problems
- Weight loss
Patients who have developed ketoacidosis since beginning Type 2 Diabetes
treatment with Invokana® may want to explore their legal options.
Currently there are about 500 cases filed in a multidistrict litigation
(MDL) against Johnson & Johnson, the maker of Invokana®, alleging
that the pharmaceutical company did not adequately warn users of the risks
of ketoacidosis. An attorney can help you to determine if your case warrants
investigation. Please contact Brett H. Oppenheimer, a Kentucky lawyer,
who can help you determine if your case warrants investigation. Email
Brett using the form found on this website (or
email@example.com) or call (502)242-8877 for a free consultation.