Invokana manufacturer Janssen, a subsidiary of beleaguered pharmaceutical giant
Johnson & Johnson, faces an ever-increasing number of lawsuits for
harm suffered from the drug, and must once again strengthen the drug’s
warning label. Both the U.S. and Canada have demanded increased warnings
for Invokana, a drug approved for the treatment of Type II diabetes. Invokana
(generic canagliflozin) is an SGLT2 inhibitor. SGLT2 is a human protein
which facilitates the reabsorption of glucose in the kidneys, increasing
the excretion of glucose, and subsequently lowering blood glucose levels.
Invokana and other SGLT2 drugs also increase insulin sensitivity and the
uptake of glucose in the muscle cells.
Health Canada Issues Invokana Safety Review
In May of this year, Health Canada issued a safety review of Invokana.
The review found the use of SGLT2 inhibitors could increase a patient’s
risk of developing diabetic ketoacidosis, a potentially deadly illness.
In some cases, patients using Invokana have developed ketoacidosis, a
condition in which the body produces extremely high levels of ketones,
leading to pain in the abdomen, extreme fatigue and difficulty breathing.
Hospitalization can be required in order to regulate the patient’s
chemical balance. Health Canada found that across the globe, 419 cases
of ketoacidosis were reported among those patients taking an SGLT2 inhibitor.
FDA Follows Health Canada in Requiring Strengthened Invokana Warnings
The FDA soon followed suit in June 2016, requiring strengthened warnings
on Invokana, including the risk of acute injury to the kidneys. The warning
regarding kidney injury came after 101 confirmable cases of acute kidney
injury were linked to Invokana and Farxiga, a similar drug. According
to the FDA, at least half of the cases of acute kidney injury occurred
within a month of the patient starting Invokana. The majority of these
patients improved after the medication was discontinued.
Were Sufficient Safety Trials for Invokana Conducted?
Johnson & Johnson and Janssen were the first manufacturers to bring
an SGLT2 inhibitor drug to the market. Astra Zeneca soon followed with
their own SGLT2 inhibitor drug, Farxiga. Invokana has dominated the market
among SGLT2 drugs, however the Institute of Safe Medication Practices
released a report which identified potential issues with Invokana, including
the question of whether J & J and Janssen conducted sufficient safety
trials for the drug before marketing it to the public.
Public Citizen Calls Invokana a “Do Not Use” Drug
Public Citizen, a consumer watchdog, categorized Invokana as a “Do
Not Use” drug, noting only nine controlled safety trials, lasting
between 6 and 12 months were conducted on the drug prior to marketing.
Eight of those nine trials did not measure clinically meaningful results,
while the trial evaluating adverse cardiovascular outcomes found those
taking Invokana had a higher risk of such an event. When the FDA was considering
approval of Invokana, several members of the panel raised concerns regarding
these adverse cardiovascular outcomes as well as potential kidney function
impairment, however the panel approved the drug with a 10 to 5 vote.
AACE Invokana Conference Findings “Unclear”
Last October, the American Association of Clinical Endocrinologists held
a conference in Dallas. One of the subjects discussed during that conference
was the potential risks of Invokana and other SGLT2 inhibitor drugs, however
their findings regarding those risks were “unclear.” More
than 6,000 medical professionals who routinely treat patients with both
Type I and Type II diabetes comprise the AACE.
Kidney Disease, Heart Attacks and Ketoacidosis Associated with Invokana
Unfortunately, diabetic patients are already prone to developing kidney
issues, therefore a drug which has been found to increase the risk of
kidney disease or failure can be extremely serious for these patients.
Diabetic ketoacidosis, when not treated promptly, can lead to kidney failure
as well. Patients who take Invokana or another SGLT2 inhibitor drug should
be aware of the following health symptoms:
- Unusual fatigue;
- Difficulty breathing;
- Swollen legs, ankles or feet;
- Lessened sensation in the extremities;
- Decreased appetite;
- Urination changes;
- Pain between the rib and hip, and
- A metallic taste in the mouth.
If you have suffered injury after taking Invokana, it is important to speak
to an experienced Invokana attorney, who can ensure your rights are fully
To learn more about your legal options or to schedule a free consultation, call Golomb & Honik, P.C. today. We represent clients in Pennsylvania
and throughout the United States.