What is Invokana?
Invokana is in a new class of medication called SGLT2 inhibitors used to
treat Type II diabetes. Phase III clinical trials of the drug showed patients
taking Invokana reduced their overall body weight and systolic blood pressure
and improved their blood glucose control. Invokana reduces blood glucose
via the kidneys, increasing glucose loss in the urine. Normally when glucose
is filtered out through the kidneys, it is reabsorbed back into the bloodstream;
however, Invokana blocks this response and can trigger dangerous levels
of blood acids which can lead to coma and even death. After reviewing
adverse events reports, the FDA issued a warning regarding all of the
drugs in this class.
Heart Attack and Stroke Related to Invokana
In one Invokana trial conducted by Janssen Pharmaceutical Company (a subsidiary
of Johnson & Johnson) there was an increase in heart attack and stroke
among those taking the drug. The risk occurred within the first thirty
days the patient took Invokana. Thirteen patients who took Invokana in
the trial suffered a major cardiovascular event within the first thirty
days, compared with one patient taking a placebo. While the risk of a
major cardiovascular event reversed after the first thirty days, a significant
increase in LDL cholesterol was seen among those taking Invokana. Despite
the results of this trial, the FDA did not require warnings on the labeling
of Invokana warning about potential heart attack and stroke risks.
Potential Risks of Kidney Failure and Bladder Cancer among Those Taking Invokana
Another health concern regarding Invokana is the risk of kidney failure
and bladder cancer. Many of those who suffer from Type II diabetes already
have some level of kidney disease. Some research pointed to a worsening
of kidney disorders among those taking Invokana. The labeling on Invokana
does state that Invokana can increase serum creatinine and decrease eGFR
in the body. Studies show that those over the age of 75 are the most likely
to suffer a severe kidney disorder while taking Invokana. While no clinical
trials done by Janssen pointed to an increased risk of bladder cancer,
some other studies noticed a tendency of the drug to lead to infections
which could then be “causal of new cancers.”
FDA Drug Safety Announcement Regarding Serious Health Risks of Ketoacidosis
As recent as May 2015, the FDA warned that medications such as Invokana
could put patients at risk for a serious health condition known as ketoacidosis.
Ketoacidosis develops when the patient is unable to produce sufficient
insulin. Insulin allows sugar (glucose) to ender the body’s cells,
providing needed energy to tissues and muscles. When the body lacks insulin,
it breaks down fat to provide energy, producing a buildup of toxic acids
in the bloodstream.
Ketoacidosis can lead to coma and even death. The American Diabetes Association
describes ketoacidosis as a condition which causes the body to produce
excessive levels of blood acids or ketones. The FDA warning came after
the agency reviewed twenty adverse event reports from patients who ended
up seriously injured or hospitalized after taking Invokana and suffering
ketoacidosis. Symptoms of ketoacidosis include trouble breathing, abdominal
pain, nausea and vomiting, unusual sleepiness, unusual fatigue and mental
The following factors can increase your likelihood of having medical problems
while taking Invokana: high cholesterol, a low-salt diet, heart disease,
liver disease, kidney disease, high blood pressure, low blood pressure,
electrolyte imbalance or the use of insulin or oral diabetic medications.
If you have suffered, serious, adverse symptoms related to Invokana, it
could be beneficial to speak to a personal injury attorney who is familiar
with Invokana and the current lawsuits against the manufacturer. You could
be entitled to recover compensation for medical expenses, pain and suffering
and loss of income.
Contact Our National Dangerous Drug Lawyers
At Golomb & Honik, P.C., our dangerous drug lawyers have considerable
experience and success representing patients and families that have been
injured by a negligent drug manufacturer. If you or someone you love has
suffered injury after taking the dangerous drug Invokana, we can help.
To learn more about your rights and legal options, call the Philadelphia
defective drug lawyers at Golomb & Honik, P.C. today at
1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.