A new safety alert sent out by the FDA associates the drugs Invokana and Invokamet (canagliflozin) with nearly twice the risk of leg and foot amputations compared with those taking a placebo. These results came from an ongoing clinical trial known as CANVAS (Canagliflozin Cardiovascular Assessment Study). The safety alert followed a four-and-a-half year interim analysis by an independent CANVAS monitoring committee. The analysis found the rate of amputation—mostly toes—per every 1,000 patients taking Invokana was seven for those taking 100 mg per day and five for those taking 300 mg per day. These numbers were compared to three patients per 1,000 who had a foot, leg or toe amputation and were taking a placebo drug.
Invokana Marketed Aggressively in 2013
Invokana was introduced by Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, only a little more than three years ago, in March 2013. Invokana was the first on the scene of a new class of drugs to treat Type II diabetes. This class of drugs are known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.
Invokamet combines canagliflozin with another diabetes drug, Metformin. Invokana, along with two other SGLT2 drugs from other manufacturers, has been aggressively marketed as a vastly superior treatment for Type II diabetes. Because of the huge marketing push, doctors have switched many of their diabetic patients to Invokana, despite some serious adverse reports of diabetic ketoacidosis, kidney failure, bone fractures, and now, amputation problems.
European Regulators Voiced Same Concerns Regarding Invokana Amputation Risk
The FDA safety alert comes less than two months after regulators in Europe voiced similar concerns. Johnson & Johnson has already faced an ever-increasing number of Invokana and Invokamet lawsuits filed by patients across the nation who have suffered kidney failure or diabetic ketoacidosis as a result of taking the drug. These complaints allege J & J and Janssen failed to adequately research the side effects of Invokana prior to marketing it to the public, and recklessly promoted Invokana without providing sufficient warnings to patients and doctors. Invokana had been on the market less than two years when the FDA launched an investigation into a potential link between Invokana and ketoacidosis.
Prior Invokana Warnings of Ketoacidosis and Kidney Disease
Ketoacidosis is a dangerous, sometimes fatal build-up of acid levels in the blood. In December 2015, the FDA required J & J to add warnings to Invokana labeling which warned about the potential risks of ketoacidosis. Those taking Invokana were urged to stop taking the drug if they experienced any symptom such as fatigue, nausea, abdominal pain, respiratory issues, or vomiting.
The FDA is now telling those taking Invokana or Invokamet to notify their healthcare professional immediately if they experienced any type of new pain, sores, tenderness, ulcers or infections in their legs or feet. Prior to the warning about ketoacidosis, the FDA required J & J to add bone fracture warnings to the labeling of Invokana in September 2015. There are indications that Invokana and Invokamet may also lead to a decrease in bone density.
Lawsuit Filed in February Alleges J & J Downplayed Risks of Invokana
A product liability lawsuit, filed in February 2016, alleges J & J downplayed the risk of kidney failure from Invokana, as the warning labels only indicated kidney “problems” to be a “possible side effect.” In the lawsuit, the plaintiff stated she began using Invokana about a year after it was introduced—and heavily marketed as a safe, effective treatment for Type II diabetes. Her lawsuit indicates she believes J & J was well aware that using Invokana could increase the risk of kidney failure. She experienced acute kidney failure, and says she would never have taken the drug had she been made aware of the potential adverse health risks associated with Invokana and Invokamet.
457 Adverse Event Reports Submitted in Invokana’s First Year on the Market
During its first year on the market, Invokana users submitted 457 serious adverse event reports to the FDA regarding the drug. With the latest findings on amputations, it appears Invokana may be even more dangerous than previously believed. Although the FDA is not telling those taking the drug to stop taking it, they are advising patients to be aware of the risks associated with Invokana and to watch carefully for any potential adverse reactions.
Contact Our National Dangerous Drug Lawyers
At Golomb Legal, our dangerous drug lawyers have considerable experience and success representing patients and families that have been injured by a negligent drug manufacturer. If you or someone you love has suffered injury after taking the dangerous drug Invokana, we can help. We believe in holding negligent pharmaceutical companies responsible for their actions and will fight aggressively for you and your family.
To learn more about your rights and legal options, call the Philadelphia defective drug lawyers at Golomb Legal today at (215) 278-4449 or fill out our confidential Contact Form.