A potentially fatal side effect of Invokana, as well as other SGLT2 inhibitors,
is expected to lead to a flurry of lawsuits against the manufacturers
of these drugs. Invokana is used in the treatment of Type II diabetes.
Yet, this drug can trigger dangerous levels of blood acids, which can
lead to coma and even death. After reviewing 20 adverse event reports,
the FDA issued a warning regarding SGLT2 inhibitors, including Invokana.
The FDA determined that ketoacidosis can occur among those taking SGLT2
inhibitors such as Invokana.
Diabetic ketoacidosis is a very serious condition resulting from a lack
of glucose to the body’s cells. When the cells don’t get the
energy-producing glucose, they begin to burn fat for energy which in turn
produces ketones. Ketones are chemicals created when the body breaks down
fat for energy, and as ketones build up in the body, it becomes more acidic.
Early warning signs of ketoacidosis include frequent urination, high blood
glucose levels, dry mouth, excessive thirst, extreme fatigue, flushed
skin, abdominal pain, nausea and vomiting, difficulty breathing and confusion.
How Invokana Works
Invokana is generally used in conjunction with diet and exercise and can
also be used with other diabetic drugs such as metformin. Type II diabetes
affects some 24 million people in the U.S. When left untreated, Type II
diabetes can lead to cardiovascular issues, loss of vision, kidney damage
and nerve damage. Invokana works as an inhibitor of sodium glucose co-transporter
2, blocking the reabsorption of glucose by the kidneys. Janssen conducted
nine clinical trials with more than 10,000 patients prior to gaining FDA
approval, and were required to conduct five more long-term studies, including
one on cardiac issues related to Invokana, and others on pancreatic disease,
cancer, liver and bone loss issues as related to Invokana.
FDA Adverse Event Reports
In addition to the current FDA warnings, there have been more concerns
regarding Invokana, with more than 450 serious adverse event reports filed
with the agency. Fifty-four of those reports were of kidney failure or
impairment, fifty-four were for severe dehydration, eleven for the development
of kidney stones, fifty cases of serious urinary tract infections and
fifty-two cases of abnormal weight loss. Other than renal issues, there
were fifty cases of allergic responses to Invokana.
Some question whether the benefits of Invokana outweigh the potential risks;
prior to receiving FDA approval in 2013, those taking Invokana in clinical
trials were found to have a higher risk of developing a fungal infection
than others in the general population. Animal studies found that long-term
exposure to Invokana could lead to bone abnormalities, kidney cancer,
testicular cancer and long-term kidney disease.
Institute for Safe Medication Practices Report
At this time lawyers are accepting cases for those who have suffered harm
after taking Invokana for their Type II diabetes. Invokana was developed
by Mitsubishi Tanabe Pharma, marketed under license by Janssen, a division
of Johnson & Johnson. The FDA warning came on the heels of a report
by the Institute for Safe Medication Practices, which questioned whether
the potential risks of Invokana outweigh the drug’s benefits. Invokana
received FDA approval and was marketed in 2013—at the same time
pancreatic cancer links were associated with the diabetic drugs Januvia,
Janumet, Victoxza and Byetta.
Getting the Help You Need
Most cases, which involve dangerous drugs allege design, manufacturing
or marketing defects as well as a company’s failure to warn of specific
side effects. Patients who have experienced ketoacidosis, heart issues,
stroke, pancreatic or liver disorders or other issues associated with
Invokana should speak to a knowledgeable dangerous drug attorney who is
familiar with the issues associated with Invokana.
At Golomb & Honik, 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. We believe
in holding negligent pharmaceutical companies responsible for their actions
and will fight aggressively for you and your family.
To learn more about your rights and legal options, call the Philadelphia
defective drug lawyers at Golomb & Honik today at
1-800-355-3300 or 1-215-985-9177 or fill out our confidential