Invokana side effects were known in 2013

invokana-lawyerBefore the FDA approved Invokana in 2013, concerns were raised about the diabetes drug’s potential to cause heart problems. In January 2013, a review by the FDA’s Endocrinologic and Metabolic Drug Advisory Committee found that Invokana may be associated with an increased risk of severe heart problems, including heart attacks and strokes. Invokana trials revealed the type 2 diabetes medication raised cholesterol levels, and the elevated risk of heart attack was greatest within the first 30 days of taking Invokana.  The FDA approved Invokana after reviewing nine clinical trials involving more than 10,000 patients.

Despite the concerns raised in the pre-approval clinical trials about the high risk margin for heart problems due to Invokana, the FDA panel ultimately voted to approve the use of Invokana for the treatment of type 2 diabetes. To ensure the safety of the diabetes patients taking Invokana, the FDA required Johnson & Johnson to conduct five postmarket studies on the potential health risks of the product, such as cancer risk and risks to the heart, pancreas, liver, and bones

The U.S. Food and Drug Administration (FDA) approved Invokana, the first drug in a class of type 2 diabetes medications called SGLT-2 inhibitors, which manage blood sugar levels by causing excess sugar to be passed through the patient’s urine after the kidneys filter it from the blood. Other diabetes treatments worked by lowering blood sugar levels by altering how the body produces and reacts to insulin. However, SGLT-2 Inhibitors, such as Invokana, work completely independent of insulin.

With such a large market of potential patients in the United States, financial analysts had expectations that Invokana was poised to earn at least $1 billion in annual sales for Johnson & Johnson. Johnson & Johnson was the first company to achieve FDA approval, and was the first company to commercially release an SGLT-2 inhibitor.

Institute for Safe Medication Practices: hundreds of Invokana injuries

In 2014, the Institute for Safe Medication Practices (ISMP) released that there were hundreds of adverse events as a result of taking Invokana. Serious medical conditions linked to Invokana included kidney failure, kidney stones and UTIs. Additionally, many questions about the adverse health effects of taking Invokana to treat diabetes still remained unanswered.

In May 2015, the Food and Drug Administration (FDA) released a safety communication regarding the use of SGLT-2 inhibitors like Invokana, which reports have shown can lead to a life-threatening condition called ketoacidosis, as well as to kidney failure and heart attack. The FDA has received 20 reports of these SGLT-2 drugs causing ketoacidosis in users, which is a serious medical condition in which the body is unable to produce enough insulin, and levels of blood acids (known as ketones) are too high.