Not All Doctors Were on Board with Invokana Approval

November 3, 2015  |  Dangerous Drugs & Devices, Pharmaceuticals

When the FDA convened an advisory board of 15 doctors to approve the diabetes drug Invokana in 2013, the results were 10-5 in favor of allowing the drug to enter the market. The five doctors who voted against Invokana approval, according to The New York Times, voiced concerns about possible cardiovascular risks linked with the medication.

Invokana is among a class of medications known as sodium-glucose cotransporter-2 inhibitors. Other drugs in this class include Invokamet, Glyxambi, Xigduo XR, Farxiga, and Jardiance. These drugs are meant to reduce the amount of sugar in a patient’s blood by removing excess levels through urination.

However, some medications (such as Invokana) that are designed to control blood sugar in diabetics can increase the risk of cardiovascular disease. According to the article, one of the clinical trials that were submitted to the FDA prior to Invokana approval showed that 13 patients participating in the trial had suffered a stroke or heart attack. This is compared to only one patient in the trial who was taking a placebo.

Troubling Developments
Concerns continue to grow long after Invokana approval was granted. For example, the FDA issued a Safety Communication in May 2015, warning that 20 patients had reported they developed diabetic ketoacidosis after taking the drug. Then, in September 2015, the agency added new information to the drug’s warning label to inform Invokana users about an increased risk of bone fractures as well as a loss of bone density.

According to the Institute for Safe Medication Practices (ISMP), more than 450 adverse events linked to Invokana have been reported to the FDA. These include urinary tract infections, kidney stones, weight loss and even kidney failure.

If you have suffered complications due to using Invokana, the national law firm of Baron & Budd may be able to help. Give us a call at 866-912-8281 or complete our contact form to learn more.

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