The FDA has warned that Invokana and other diabetes drugs are associated with severe urinary tract infections that spread to the bloodstream and cause urosepsis.
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Invokana makes patients urinate more often, and the urine contains more sugar than normal. This can promote the growth of bacteria, which is why urinary tract infections (UTIs) are so common. In some cases, bacteria spreads to the bloodstream and causes urosepsis.
FDA Safety Warning
In December 2015, the FDA issued a Safety Communication to warn about the risk of urosepsis from diabetes drugs in the SGLT2 inhibitor class. The agency received 19 reports of urosepsis and pyelonephritis (kidney infections) in patients who developed severe urinary tract infections.
The FDA asks patients to contact a health care professional for symptoms of a urinary infection:
“Patients should also be alert for signs and symptoms of a urinary tract infection, such as a feeling of burning when urinating or the need to urinate often or right away; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine.”
List of SGLT2 Inhibitor Diabetes Drugs
- Invokana (canagliflozin)
- Invokamet (canagliflozin and metformin)
- Farxiga (dapagliflozin)
- Xigduo XR (dapagliflozin and metformin extended-release)
- Jardiance (empagliflozin)
- Glyxambi (empagliflozin and linagliptin)
- Synjardy (empagliflozin and metformin)
What is Urosepsis?
Urosepsis is a life-threatening complication of a urinary tract infection. It occurs when bacteria spreads to the bloodstream, causing bacteremia (“blood poisoning”). Sepsis occurs when the body fights the infection by triggering whole-body inflammation.
What Causes Urosepsis?
Urosepsis is usually caused by a bacterial infection from E. coli, which is naturally found in the intestinal tract. Urosepsis can also occur after infections from sexually-transmitted bacteria and lacerations from catheters inserted in the urethra.
Symptoms of Urosepsis
- Low body temperature
- Rapid breathing
- Fast heartbeat
- Painful urination
- Trouble urinating
- Frequent urination
Hospitalization is necessary to treat urosepsis, where patients will receive intravenous (IV) antibiotics, fluids, oxygen, and other medications to raise blood pressure and treat pain or nausea. Without treatment, urosepsis can cause “septic shock.” This causes a sudden drop in blood pressure and decreased circulation of blood to vital organs. This can rapidly lead to multi-organ system failure and death.
Need a Urosepsis Lawyer in Texas?
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The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas urosepsis lawyers for a free lawsuit review.