The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

We’ve all seen direct-to-consumer advertisements for medications. They usually show people improving over a short period of time, and experiencing a much more vibrant and exciting life after taking the company’s drug. Though the side effects are usually listed, the overall messages in these advertisements are that if the viewer takes the drug, he or she will likely feel much better.

In March 2015, watchdog group Public Citizen raised concerns about these advertisements, particularly the ones featuring diabetes medications like Invokana (canagliflozin). They sent a letter to the Food and Drug Administration (FDA) urging them to take action against manufacturers of these drugs, since the advertisements were suggesting the drugs could help patients lose weight—a claim not approved by the FDA.

Invokana Advertisements Indicate that Patients May Lose Weight

A physician can prescribe a medication for any reason he deems appropriate, whether the FDA has approved the medication for that use or not. A drug manufacturer, however, cannot legally advertise a drug for anything other than the FDA-approved use.

In the case of Invokana, the FDA approved it in March 2013 for the treatment of type 2 diabetes—specifically, for reducing blood glucose levels. It did not approve it as a medication that would help patients lose weight.

Some of the Invokana advertisements, however, have described the alleged benefits of the drug when it comes to shedding a few pounds. The disclaimers add that the drugs are not meant for that purpose, but the implication is still there, which potentially encourages patients to ask for the drug simply for that reason.

In their letter, Public Citizen urged the FDA to take action against the manufacturer, Janssen Pharmaceuticals, to make them drop the implication that Invokana could help type 2 diabetes patients to lose weight.

Invokana Tied to Diabetic Ketoacidosis

There are other reason to be concerned about the widespread use of Invokana and other similar type 2 diabetes drugs. Called “sodium-glucose co-transporter 2 (SGLT-2) inhibitors,” these drugs stop the kidneys from reabsorbing some glucose, causing it to be flushed out through the urine. The action results in lower blood glucose levels, but could potentially cause side effects, like urinary tract infections and kidney problems.

In May 2015, the FDA released a drug safety communication warning physicians and patients about a new concern with SGLT-2 inhibitors. They had received 20 reports at the time—and have since received more—concerning patients who took the drugs, and then suffered from a potentially serious condition called “diabetic ketoacidosis.”

This condition occurs when the blood becomes too acidic, and can lead to a coma and even death if not treated correctly. Symptoms may include difficulty breathing, nausea and vomiting, abdominal pain, confusion, unusual fatigue, and a fruity odor on the breath. The FDA warned doctors and patients to be on the lookout for symptoms like these, and to get medical attention right away if they occur.

Invokana Linked to Kidney Impairment and Failure

The Institute for Safe Medication Practices (ISMP) released their QuarterWatch publication for the second quarter of 2014, and found that in just a year, Invokana had been linked with over 450 reports of problems, including kidney impairment and failure, urinary tract infections, and dehydration and other fluid imbalances.

Considering the serious nature of these potential side effects, it makes sense that the advertisements enticing patients to try them should be tempered, to protect patients from asking for something they think is going to improve their lives, only to have it cause more health problems.

Invokana lawyers are now reviewing potential Invokana lawsuits, to help patients who suffered side effects recover damages in court.

Comments are closed.

Of Interest