Health Authorities Strengthen Invokana Warnings

Health Authorities Strengthen Invokana Warnings

Posted By Golomb & Honik, P.C. || 14-Oct-2016

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;
  • Vomiting;
  • Nausea;
  • 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 protected.

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.

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