The U.S. Food and Drug Administration (FDA) recently issued a safety warning
for certain drugs used to treat type 2 diabetes. According to the agency,
medicines containing canagliflozin, dapagliflozin, and empagliflozin may
lead to ketoacidosis, which is a serious and potentially deadly condition
where the body produces high levels of blood acids called ketones.
The drugs impacted by the safety communication are known as sodium-glucose
cotransporter-2 (SGLT2) inhibitors. The medications, which are sold under
the brand names Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance, and
Glyxambi, lower blood sugar in diabetes patients by causing the kidneys
to remove sugar from the body through the urine.
According to the
FDA’s safety announcement, the agency received 20 reports of the medications causing ketoacidosis
between March 2013 and June 2014. All of the patients required emergency
medical care and were hospitalized. The agency also stated that it continues
to receive additional reports about the dangerous side effect of the diabetes
The FDA is currently investigating the safety issue and will determine
whether changes are needed in the prescribing information for SGLT2 inhibitors.
In the meantime, the FDA advises that patients should pay close attention
for any signs of ketoacidosis and seek medical attention immediately if
they experience symptoms such as difficulty breathing, nausea, vomiting,
abdominal pain, confusion, and unusual fatigue or sleepiness.
The FDA also warns that health professionals should evaluate patients prescribed
SGLT2 inhibitors for the presence of acidosis, including ketoacidosis,
in patients experiencing these signs or symptoms. The agency also advises
that physicians discontinue SGLT2 inhibitors if acidosis is confirmed
and take appropriate measures to correct the acidosis and monitor sugar levels.
If you or someone you love has been seriously injured by a dangerous or
defective drug or medical device, don’t hesitate to
contacta San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.