Following the conclusion of two clinical trials, regulators with the Food
and Drug Administration (FDA) have required Johnson & Johnson to add
new warnings to the label of Invokana, a medication used to treat patients
with Type 2 diabetes. The results of those trials found that patients
taking Invokana, or canagliflozin, experienced foot and leg amputations
at twice the rate as patients who were administered a placebo.
According to the FDA, Johnson & Johnson will now have to warn consumers
about these risks using a boxed warning, the most serious warning available
under FDA guidelines.
Invokana has made headlines in recent months and years over a number of
lawsuits filed by consumers who took the medication and experienced a
number of serious adverse health effects, including kidney failure, heart
attack, and stroke. The medication has also been associated with ketoacidosis,
a life-threatening condition that occurs when there isn’t enough
insulin in the body. Invokana is manufactured by Janssen Pharmaceuticals,
a subsidiary of Johnson & Johnson.
The FDA has issued several other warnings regarding Invokana prior to the
boxed warning for leg and foot amputations. This includes a revised warning
in 2015 associating the drug with increased risks for ketoacidosis and
serious urinary tract infections that may lead to damage or failure of
Since Invokana has become a publicly available medication, there have been
numerous reports of injuries and serious infections associated with the
drug. As a result, many of these victims have filed lawsuits in an effort
to hold Johnson & Johnson accountable for failing to ensure the safety
of its products before making them available to the public.
At Biren Law Group, our personal injury attorneys dedicate their careers
to fighting on behalf of the injured and the wronged, including those
who have been harmed as a result of defective drugs and drug manufacturers
that place profits over people. If you or someone you love has experienced
adverse health effects after taking Invokana, you may have grounds to
pursue a personal injury lawsuit. Our legal team is readily available
to help you learn more about your rights and how we can help during a
Contact us to speak with a member of our legal team.