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With concerns over the potential side effects of Invokana continuing to mount, and an increasing number of lawsuits being filed over the drug makers’ failure to warn about potential risks associated with the new-generation diabetes drug, Johnson & Johnson reports that sales have slowed, suggesting that medication may have lost its commanding share of the market.
According to second quarter financial results released on July 18, Johnson & Johnson’s Invokana performed below revenue expectations.
In addition to a steady stream of health warnings regarding Invokana that have been issued over the past year, the drug also faces competition from others in its class, like Jardiance and Farxiga; all of which are known as sodium-glucose costransporter-2 (SGLT2) inhibitors.
In December 2016, Invokana controlled 51% of the SGLT2 market. However, by July 7, that share has dropped to 45%. During that same time, the market share for Eli Lilly and Boehringer Ingelheim’s Jardiance has climbed from 16% of the market to 23%.
Experts say that while both drugs have been linked to certain health risks, such as diabetic ketoacidosis, Jardiance may be seeing gains due to specific problems linked only to Invokana, such as amputations, as well as recent research that suggests Jardiance may actually reduce the risk of heart problems.
In May, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other SGLT2 inhibitors claim is a unique risk with Invokana, not seen with their competing drugs.
Additionally, in August 2016, the makers of Jardiance announced that clinical trials indicated it may lower the risk of heart attack and stroke. The makers of Invokana later made similar claims, but with much weaker numbers, particularly when it came to mortality.
The differences highlight just how little is actually known about the safety profile of these drugs. The FDA has required the drug makers to change the label several times since originally approving the new diabetes treatment as more problems came to light.
In December 2015, diabetic ketoacidosis warnings were added to Invokana and other SGLT2 inhibitors, indicating for the first time that users may face of risk of developing this serious condition. Prior Invokana warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting, which is critical for avoiding serious complications from diabetic ketoacidosis.
Concerns about a potential link between Invokana and kidney failure have also emerged since the drug hit the market. In June 2016, the FDA required that new information be added to the drug label about the risk of acute kidney injury and other kidney issues.
A growing number of lawyers are now reviewing potential Invokana lawsuits are now being filed on behalf of individuals who have suffered diabetic ketoacidosis, kidney injuries or amputations, alleging that the drug makers failed to adequately research the potential side effects before aggressively marketing the new generation diabetes treatments.