Type 2 diabetes is a medical condition affecting over 9 percent of the population or an estimated 28 million Americans. The most common drug to treat Type 2 diabetes is Invokana.
Manufactured by Johnson & Johnson, Invokana is the brand name of the drug canagliflozin, which is a sodium glucose cotransporter-2 (SGLT2) inhibitor. This class of Type 2 diabetes drugs lowers blood sugar by causing the kidneys to remove sugar from the body via urine. This prevents sugar from being reabsorbed into the blood.
In March 2013, the FDA approved the drug, however by May 2015 they were warning that this drug may lead to devastating side effects.
This side effects can include:
Invokana + Type 2 Diabetes
Type 2 diabetes is a condition that affects the body’s ability to break down sugar (glucose) as an energy source. Insulin is the body’s means of breaking down sugar in the blood for energy. Type 2 diabetes either causes the body to resist the effects of insulin or to produce inadequate amounts. If glucose levels in the blood are too high, it can be dangerous and cause health complications. Along with other members of the SGLT2 inhibitor class, Invokana works by triggering the kidneys to take sugar from the body through the urine to lower blood sugar levels.
On May 15, 2015, the United States Food and Drug Administration (FDA) issued a safety communication regarding SGLT2 inhibitors, including Invokana. These drugs may lead to ketoacidosis. This is a serious condition where the body produces high levels of blood acids called ketones. It may require hospitalization.
Other risks include:
- Ketoacidosis, which may lead to diabetic coma or death
- Cardiovascular complications
- Kidney damage or failure
- Bone fracture risk
- Decreased bone mineral density
As of January 2017, there is no known recall of Invokana or other SGLT2 inhibitors. The FDA’s Safety Communication advised patients of looking for out for following when using Invokana and other SGLT2 inhibitors:
- Diabetic ketoacidosis and ketoacidosis have been reported in patients using Invokana. Ketones can build up in the body if insulin levels are too low or during prolonged fasting.
- Be aware of the signs of ketoacidosis: difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Seek medical attention immediately if you experience any of these symptoms.
- Ketoacidosis associated with SGLT2 inhibitors may be present even if the blood sugar is not very high.
- The safety and efficacy of SGLT2 inhibitors have not been established in patients with Type 1 diabetes. The FDA has not approved Invokana for use for Type 1 diabetics.
- Do not stop or change your diabetes medicines without first talking to your healthcare professional. When untreated, diabetes can lead to serious problems, including blindness, nerve and kidney damage and heart disease.
- Read the patient Medication Guide or Patient Package Insert you receive with your SGLT2 inhibitor prescription.
- Talk to your healthcare professional if you have questions or concerns about SGLT2 inhibitors or any of your other diabetes medicines.
- Report side effects from SGLT2 inhibitors to the FDA MedWatch program.
The FDA has advised healthcare professionals to inform patients and caregivers about the signs and symptoms of metabolic acidoses, such as tachypnea or hyperventilation, anorexia, abdominal pain, nausea, vomiting, lethargy, or mental status changes, and instruct them to seek medical attention immediately if they experience the signs or symptoms.
- March 29, 2013 – Canagliflozin became the first SGLT2 inhibitor to be approved by the FDA.
- January 8, 2014 – The FDA approved a second SGLT2 inhibitor, dapagliflozin.
- June 6, 2014 – The FDA identified 20 cases of diabetic ketoacidosis, ketoacidosis, or ketosis linked to SGLT2 inhibitor use.
- May 15, 2015 – FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood.
- February 2016 – Plaintiffs file a lawsuit stating the drug caused ketoacidosis and other severe side effects.
- April 2016 – Reports that the FDA has released information that Invokana and other SGLT2 inhibitor class drugs may decrease bone density among patients using them and also increase the overall risk of bone fracture development.
- May 2016 – The FDA issued a drug safety communication report saying “interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin.”
- June 2016- FDA strengthens existing warning pertaining to risk of acute kidney injury for canagliflozin.
Speak to an Attorney Today
If you or a loved one has been harmed by Invokana, you need an attorney with experience helping people who have been harmed by pharmaceutical drugs. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against drug manufacturers to get clients what they need.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Therefore, if the conduct of a drug company in manufacturing and selling drug is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed complications after taking Invokana, please speak to us to learn more about your rights.
Case evaluations are free of cost and without obligation. Call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.