As of May 16, 2017 the FDA issued a warning about a sharp increase in the risk of lower limb amputations among patients taking the popular Diabetes drug Invokana, sometimes sold under the brand names Invokamet and Invokamet XR.
Invokana has long been known to increase the risk of serious and possibly fatal ketoacidosis, but a recent study showed that people taking Invokana faced double the risk of amputations compared with those taking a placebo. The makers of this drug failed to properly test it for adverse results, withheld critical information from the FDA, and failed to warn doctors and patients of the increased dangers it presented.
In summer 2015, the FDA warned that Sodium-glucose cotransporter-2, or SGLT2, inhibitors used in treating Type 2 diabetes may result in a serious condition of too much acid in the blood, or diabetic ketoacidosis (DKA). The FDA has, more recently, warned about broken bones and kidney injuries associated with these inhibitors. Since summer 2017, new risks have come to light, especially in patients that were prescribed Invokana, a type of SGLT2 inhibitor.
According to the Mayo Clinic, the drug “work[s] by preventing the kidneys from reabsorbing sugar into the blood. Instead, the sugar is excreted in the urine. Side effects may include yeast infections and urinary tract infections, increased urination and hypotension”.
These “infections…[were found] in both women and men. The rates were high: 14% of women and 3.9% of men with near-normal kidney function developed fungal infections at rates 4-6 times higher than comparator group patients”. According to ISMP’s review, the drug also was shown to cause bone abnormalities.
The FDA warns that SGLT2 inhibitors can lead to ketoacidosis.
The FDA strongly words their warning that SGLT2 inhibitor drug labels include info about the higher risk of bone fractures and decreased bone mineral density.
The FDA strengthens their warning of a higher risk of acute kidney injuries.
The FDA orders a black box warning for the risk of lower-limb amputations.
Side effects include: ketoacidosis, yeast infections, fragile or easily-broken bones, a variety of kidney injuries, and a potential need for lower-limb amputation. The following lists are included to serve as a reference, but please consult a doctor if you think you may be exhibiting any number of these symptoms.
Lower Limb Amputations
Includes loss of toes, feet, or legs.
Symptoms of ketoacidosis, as noted by the Mayo Clinic, include:
- Excessive thirst
- Frequent urination
- Nausea and vomiting
- Abdominal pain
- Weakness or fatigue
- Shortness of breath
- Fruity-scented breath
Acute kidney injuries can include, but are not limited to:
- Kidney failure
- Dehydration or a fluid imbalance
- Kidney stones
- UTI (urinary tract infection)
- Abnormal weight loss
Symptoms of yeast infections include:
- Areas of shiny, white skin on or around the genitalia
- Moist skin on the genitalia, possibly with areas of a thick, white substance collecting in skin folds
- Irritation, itching or a burning sensation in or on the genitalia
- Redness and swelling of the genitalia
Has Invokana affected you?
Those who may be eligible for an Invokana lawsuit should contact us for a free case evaluation. We work on a contingency-fee basis.