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Amid mounting concerns over the risk of kidney injury and diabetic ketoacidosis linked to side effects of Invokana, Johnson & Johnson is touting the findings of a new study that suggests their new generation diabetes drug is more effective at helping individuals meet their blood glucose goals than competitors, such as the blockbuster treatment Januvia.
In an industry study published earlier this month in Current Medical Research & Opinion, researchers indicate that Invokana helped diabetics achieve better blood glucose control than those taking a class of diabetes medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors, such as Januvia and Janumet.
Researchers looked at data from U.S. health plans to evaluate glycemic control of patients who took 300mg Invokana once a day, compared to those who used Januvia instead. The researchers looked at changes in glycated hemoglobin (HbA1c).
The study found that 66% of the patients given Invokana achieved a treatment goal of A1C less than eight percent, compared to 58.6% of those given Januvia.
According to a press release issued by Johnson & Johnson to highlight the findings, the drug maker suggests that this real world analysis helps provide insights for physicians about how their new-generation diabetes treatment is performing post approval. However, the statement fails to discuss the emerging Invokana safety concerns that have also been linked to the drug in recent months.
Invokana Health Risks
Although Invokana has only been on the market for a few years, drug regulatory agencies in the U.S. and Europe have issued new warnings about the drug in recent months, including an indication that users should stop taking the drug and seek immediate medical treatment if they experience symptoms of diabetic ketoacidosis on Invokana.
On December 4, the FDA issued a drug safety communication following a safety review of Invokana and similar drugs, known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Invokana is the most widely used of this class, but other medications that are part of this new generation of diabetes treatments include Invokamet, Farxiga, Jardiance, Xigduo XR and Glyxambi.
The agency ordered updated label warnings and warned that patients about the risk of ketoacidosis, which involves a build up of acid in the blood that can cause severe nausea, vomiting, abdominal pain, fatigue, and trouble breathing. In most cases, hospitalization is required.
The agency also warned that urinary tract infections and kidney infections while on Invokana could become life threatening.
In February, European regulators issued very similar warnings.
The FDA also required stronger Invokana warnings about the risk of bone fractures in September 2015, adding new information about decreased bone mineral density and broken bones experienced by users.
In May 2015, an independent review of FDA adverse event reports conducted by the Institute of Safe Medication Practices (ISMP) identified a large number of problems involving kidney toxicity, including kidney failure from Invokana and other SGLT2 inhibitors.
The group raised questions about whether the potential risks associated with the medication may outweigh the benefits, leading some questions to be raised about whether an Invokana recall should be issued, or limitations should be placed on who receives the medication.
Throughout the U.S., growing number of individuals are now pursing potential Invokana lawsuits, alleging that the drug maker failed to adequately research the medication or warn about the potential side effects, placing their desire for profits before consumer safety by aggressively marketing the drug as a superior alternative for diabetes treatment without disclosing the potential risks.