Invokana is a type 2 diabetes medication that helps the body manage blood sugar. It can cause serious side effects including diabetic ketoacidosis (DKA) - a condition marked by insufficient production of insulin and a high concentration of acid in the bloodstream. Using it can also result urinary tract infections, dangerously high potassium levels, yeast and bladder infections, and hypoglycemia.
Invokana has not been recalled.
Questions & Answers
Side Effects & Adverse Reactions
New Concerns About High Levels of Blood Acid
Now, only two years after its approval, the FDA has issued a warning that Invokana could cause dangerously high levels of blood acids in some patients. The agency issued the warning in May 2015, citing 20 cases of diabetic ketoacidosis, a condition caused by the body producing abnormally high levels of blood acids known as ketones. The warning stated that the FDA identified at least 20 incidents of acidosis in people taking this drug and two similar medications, Farxiga and Jardiance, between March 2013 and June 2014. The cases of acidosis involved emergency room visits or hospitalization. The information was collected by the FDA’s Adverse Event Reporting System (FAERS) database, which is designed to support post-marketing safety programs. The reports are provided on a voluntary basis by healthcare professionals and consumers either directly to the FDA or to the manufacturers of the drug. Manufacturers who receive reports are required to send them to the FDA.
Other Side Effects
Dizziness, lightheadedness, extreme dry mouth, and frequent urination are some of the symptoms reported by people taking this medication. Muscle weakness and irregular heartbeat may be signs of dangerously high potassium levels, so people experiencing these symptoms should seek medical attention. This drug can cause bladder infections which include painful and urgent urination and fever. Taking it may also result in a yeast infection in the vagina (female genital mycotic infections including vulvovaginitis, vulvovaginal mycotic infection, vulvitis, vaginal infection, and fungal genital infection) or penis (male genital mycotic infection). Uncircumcised men and people with a history of yeast infections are more likely to experience this side effect. (drugs.com)
Other serious adverse reactions to canagliflozin include trouble breathing, tightness in chest, swelling of the mouth/lips/face/throat/tongue, rash, itching, voice hoarseness, pain, and irritation. Side effects that are more commonly reported are bladder pain, increased thirst, weight gain, loss of appetite, nausea, pain during sex, and vomiting. Anxiety, confusion, pale skin, headache, seizures, depression, and slurred speech are less commonly reported by patients. Urinary tract infection and hypoglycemia are also often experienced by individuals that use this medication with insulin or an insulin secretagogue.
This and other type 2 diabetic drugs - including empagliflozin and dapagliflozin - can cause a serious condition called diabetic ketoacidosis (DKA). People with DKA are unable to produce enough insulin, so their bodies break down fat in order to create energy. This causes acids (ketones) to accumulate in the bloodstream. Vomiting, difficulty breathing, nausea, abdominal pain, confusion, and excessive fatigue are symptoms of this complication. (fda.org)
Fetal Development/Infant Exposure
Invokana has been labeled a Category C pregnancy risk by the FDA. There is not enough information on how this drug affects human fetuses and nursing infants. It should not be taken by pregnant women - especially during their second and third trimesters. There is a limited amount of information regarding how this drug affects humans, but animal studies have shown that it is found in breast milk and can harm a developing fetus. (drugs.com)
The makers of Invokana are facing a class action lawsuit in Canada. Many people believe that this drug can cause kidney damage, kidney failure, and death. (cbc.ca)
Learn more about the Invokana lawsuit.
FDA Safety Alerts
September 2005 - The FDA warned that people taking canagliflozin are at an increased risk of bone fractures. Patients have reported fractures occurring 12 weeks after beginning this medication. In addition, those taking it can experience decreased bone mineral density, particularly at their lower spine and hip. (fda.gov)
May 2015 - Certain type 2 diabetic drugs, including canagliflozin, empagliflozin, and dapagliflozin can cause diabetic ketoacidosis (DKA), a serious condition that may require hospitalization. Those experiencing the following symptoms should seek medical attention: vomiting, nausea, trouble breathing, unusual fatigue, abdominal pain, and confusion. This drug should be discontinued if this serious complication occurs. (fda.gov)
There are no manufacturer warnings for Invokana.
FDA Labeling Changes
September 2015 - Individuals prescribed Invokana are at an increased risk for falls that can lead to bone fractures. In a study involving nine clinical trials these fractures were usually low trauma (falling from no more than standing height) and involved the upper extremities. People with moderate renal impairment benefit less from this drug compared to those with mild or normal renal function. Canagliflozin is not recommended for individuals with severe renal impairment, end stage renal disease (ESRD), or for those receiving dialysis. (fda.gov)
March 2015 - A small percentage of men and women taking this drug have discontinued using the drug after developing genital mycotic infections (fungal infections). (fda.gov)
May 2014 - Patients using this medication shouldn’t use urine glucose tests to monitor their glycemic control. This medication (and other SGLT2 inhibitors) increases the amount of glucose released in urine - resulting in positive urine glucose tests. It is not recommended to monitor glycemic control with 1,5-AG assay because doing so is unreliable for people using SGLT2 inhibitors. Alternative testing methods should be used. (fda.gov)
Invokana is used in conjunction with diet and exercise to control blood sugar in people with type 2 diabetes. It belongs to the group of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. It increases the amount of sugar released in urine and decreases the body’s absorption of sugar. It comes in the form of an oral tablet - in 100mg and 300mg strengths - and is not sold as a generic. This drug works in a different way than other diabetes medications such as Glucophage or Metformin. This medication's unique mechanism to reduce blood sugar takes place in a patient’s kidneys, where it works to block an important membrane protein from reintroducing sugar removed by the kidneys back into the bloodstream. Instead, sugar is flushed out through urine. Concerns were raised that this drug might be dangerous for people with moderate to severe kidney disease at the time it received FDA approval. (drugs.com)
Canagliflozin was developed by Janssen Pharmaceuticals, a Belgium-based, Johnson & Johnson company. It was first approved by the European Medicines Agency in July of 2011. In April of 2013, the Food and Drug Administration approved the medication (generic name canagliflozin) for the treatment of type 2 diabetes. At the time it was hailed as a game-changing, first-in-class medication for treatment of the disease. In May 2014, it was approved for use in Canada and has since been accepted by pharmacare - the nationally funded drug coverage program - of Ontario, Quebec, and Nova Scotia. It is currently manufactured by Janssen Pharmaceuticals and marketed by Johnson & Johnson. (reuters.com)
Most common adverse reactions associated with this drug (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination.