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FDA Strengthens Warnings for Invokana, Farxiga Kidney Damage

For the second time in the past year, the US Food and Drug Administration has warned consumers that two popular diabetes medications, Invokana and Farxiga, may be linked to serious side effects.

First, the agency warned of potentially fatal blood acid levels from the drugs in May of 2015, which was followed by required warning label changes in December to address both this and the potential for urinary tract infections.

Now, the FDA has strengthened warnings to doctors and patients that the drugs may also contribute to kidney damage.

 

Over 100 Kidney Damage Cases Since 2013

Invokana, also known as canagliflozin, has been sold by Janssen since 2013. Farxiga, also known as dapagliflozin, has been available from AstraZeneca since its release in 2014.

Both drugs are known as SGLT2 inhibitors, which are prescribed to lower blood sugar levels in those with type 2 diabetes by blocking glucose absorption in the kidneys. They may also help reduce blood pressure and weight levels.

Together, they are prescribed more than 4 million times each year.

According to the FDA, between March of 2013 and October of 2015, the agency received 101 reports of patients suffering acute kidney injury while using either Invokana or Farxiga. Around 50% of these injuries occurred within a month of when patients started taking the drugs.

 

Cases Range from Mild to Severe

While many patients improved after discontinuing use of Invokana or Farxiga, some required hospitalization and kidney dialysis.

Acute renal injury can be very severe in some cases, causing the kidneys to suddenly stop functioning. This can lead to a build up of waste in the body.

Kidney failure is a common condition, with more than 200,000 cases each year in the United States.

 

What should Invokana and Farxiga Patients Know?

Doctors who are considering prescribing Invokana or Farxiga are urged to determine first if patients are already at risk for kidney injury. Also, they should regularly monitor patients taking these drugs for symptoms of kidney damage, and discontinue use at the first sign of any complication.

Patients who are taking Invokana or Farxiga are urged to monitor for any symptoms of kidney failure. These may include:

  • Swelling in the arms or legs
  • Fluid retention
  • Tiredness
  • Nausea
  • Reduced urine production
  • Shortness of breath

Anyone who notices prolonged presence of these symptoms should see a doctor immediately. However, according to the FDA, patients should not stop taking Invokana or Farxiga without first speaking to a doctor, since they may experience a sudden spike in blood sugar levels.

Also, while Invokana and Farxiga are in a similar class of drugs with Jardiance, it is important to note that the new warnings for kidney damage do not apply to Jardiance.

 

New Invokana and Farxiga Lawsuits Seek Compensation for Injured Patients

SGLT2 inhibitors like Invokana and Farxiga have also been liked to ketoacidosis, bone fractures and urinary tract infection.

Last December, lawyers filed the first of many lawsuits against the makers of the drugs on behalf of patients who suffered ketoacidosis and kidney damage.

With the number of cases across the country growing quickly, experts predict these may eventually be combined into a central federal court for quicker handling and the negotiation of a settlement for victims.

For more information on the side effects and warnings associated with Invokana and Farxiga, or to speak directly with a lawyer about the ongoing litigation and your case, contact DrugNews today.

 

Sources:

FDA: Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings. (June 14, 2016). Retrieved from http://www.fda.gov/Safety/Medwatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm

Brown, T. Canagliflozin, Dapagliflozin Warnings Strengthened by FDA. MedScape. (June 14, 2016). Retrieved from http://www.medscape.com/viewarticle/864859?nlid=106448_3901&src=wnl_newsalrt_160614_MSCPEDIT&uac=232321CX&impID=1127660&faf=1

 

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