A Drug Safety Communication warning was issued by the FDA on June 14, 2016
Invokana (canagliflozin), a Type 2 diabetes drug manufactured by Johnson & Johnson.
Invokana works to lower levels of blood sugar by boosting the amount of
sugar that is removed through the urine. Another similar SGLT-2 drug,
Farxiga (dapagliflozin), was also targeted by the FDA, which asked the
manufacturer to provide stronger warnings regarding the risks of acute
Serious Kidney Failure and Injury Linked to SGLT-2 Drugs
According to FDA records, within an 18-month period, the SGLT-2 class of
prescription drugs was linked to at least 101 verifiable instances of
serious kidney failure and injury. Seventy-three of these injuries were
related to the use of Invokana and 28 to Farxiga. Some of the patients
associated with these cases of kidney damage required hospitalization
and/or kidney dialysis, four patients died while hospitalized, and 22
required admission to intensive care. The FDA found that in at least 50
percent of the patients who suffered serious levels of injury to their
kidneys, those injuries happened within the first thirty days of taking
Invokana. Among some patients, the acute kidney injuries resolved when
Invokana was discontinued, however the FDA warns that kidney injuries
are not always reversible.
Latest Kidney Warning Comes on the Heels of Invokana Amputation Warnings
This latest requirement for stronger warning labels comes on the heels
of an FDA warning issued in May of this year stating that those taking
Invokana could potentially face an increased incidence of foot and leg
amputations. The announcement regarding amputations resulted from a clinical
trial in progress, which issued interim safety results. The study, known
as the Canagliflozin Cardiovascular Assessment study, or CANVAS, had the
following results: over a period of a single year, seven out of 1,000
subjects taking 100 mg of Invokana had an elevated risk of amputation
as compared to three out of 1,000 patients who received a placebo drug.
The warnings regarding Invokana could have an adverse effect on the $1.3
billion Johnson & Johnson made from the sales of the drug in 2015.
Factors Which May Predispose Patients to Acute Kidney Injury
The FDA warned that healthcare professionals should consider the factors
which could potentially predispose a patient to acute kidney injury prior
to prescribing Invokana. These factors include:
- Congestive heart failure;
- Chronic kidney insufficiency;
- Patient’s use of other medications such as NSAIDS, angiotensin receptor
blockers, angiotensin-converting enzymes and diuretics, and
- Decreased blood volume.
The agency noted that any patient starting Invokana (canagliflozin) or
Farxiga (dapagliflozin) should be monitored for any changes in kidney
function. Should such a change be noted, the drug should be discontinued
and any impairments treated.
Canadian Patient Claims Invokana Harm
In an interview given to the
Canadian Broadcasting Corporation in the fall of 2015, a Scarsborough, Ontario woman, claimed she had been
taking Invokana for only a short time when she found she had sustained
damage to her kidneys and renal system. She is currently pursuing a class-action
lawsuit in Canada against Johnson & Johnson and its subsidiary, Janssen
Pharmaceuticals. The plaintiff seeks both punitive and compensatory damages
due to her belief that the potential risks associated with Invokana were
Invokana Lawsuits in the United States
In the United States, there are more than 150 Invokana lawsuits pending
in Missouri and Illinois, as well as cases in Philadelphia and New Jersey.
One New Jersey woman suffered diabetic ketoacidosis and severe kidney
damage after taking Invokana for only a month. The woman asserts that
she would not have taken Invokana had she been aware of the risks associated
with the drug, and claims in her lawsuit that J & J and Janssen Pharmaceuticals
negligently marketed and sold Invokana.
If you have suffered kidney damage or injury (or diabetic ketoacidosis
or amputation), it could be very beneficial to contact an experienced
Invokana attorney who can assess your situation and determine the best
course of action for your individual circumstances.
Contact Us to Request a Case Evaluation
If you or a family member has been diagnosed with kidney damage or injury
after taking the drug Invokana, contact our firm today. One of our experienced
Philadelphia product liability attorneys will evaluate your case and help
you determine if you are entitled to compensation.
To learn more about your legal options or to schedule a free consultation, call Golomb & Honik, P.C. today at (215) 278-4449. We represent clients
in Pennsylvania and throughout the United States.