ISMP Questions Invokana Safety

In recent times, Janssen Pharmaceuticals has received numerous lawsuits filed by patients claiming to have suffered serious side effects after using Invokana. While the drug hasn’t been in the market that long, the Institute for Safe Medication Practices (ISMP) has already raised apprehensions about the risk of kidney problems and diabetic ketoacidosis (DKA) linked to Invokana (known broadly as canagliflozin).

In the lawsuit filed last December, the appellant claimed that he started using Invokana back in November 2013 to control his blood sugar levels according to the Legal Examiner (2/8/16). Upon using Invokana to treat his diabetic condition, he started having serious kidney problems, which eventually turned to kidney failure. The litigation claims that the drug makers failed to adequately warn patients about the risk of life-threatening side effects of Invokana, and the appellant claims he wouldn’t have taken the drug if he was made aware of its risks.

An ISMP Quarter Watch report looks at the safety of Invokana and probes “whether enough is known about this agent to be certain that its benefits prevail over its risks.” In March 2013 is when Invokana was approved, however ISMP says a key issue with the medication is that it causes “significant extents of sugar to be defecated in the urine.” The organization claims most of the antagonistic event reports could have been soundly predicted, given how the medication functions.

As a matter of fact, the ISMP notes that during the first year of approval, 457 serious adverse event reports were linked to Invokana – some of which may overlap in the same individual – including kidney stones (11 cases), urinary tract infections (50 cases), dehydration and fluid imbalances (54 cases), kidney failure or damage (54 cases), and anomalous or other weight loss (52 cases). Two types of hypersensitivity were also recognized: rapid swelling of the face, throat, lips, or tongue; or skin rashes.

“The unanswered question about canagliflozin – shared in part by other diabetes drugs – is whether it has medical benefits, and whether those benefits are greater than its risks,” ISMP writes. It points out the drug was approved when it hadn’t been tested in enough individuals within the required time scale to find out if it is safe to use.

The US Food and Drug Administration (FDA) issued a drug safety communication about SGLT2 inhibitors (the class of drug that includes Invokana) on May 15, 2015. The issuance contained warning about SGLT2 inhibitors links to keroacidosis, in which an individual’s body yields high levels of blood acids. The FDA updated that warning to include a risk of urinary tract infections by December of that year. The FDA also noted it had recognized “19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that began as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014.”

Individuals who have suffered serious side effects from using Invokana have filed defective drug lawsuits against the drug makers and marketers.

 

It's only fair to share...Share on FacebookShare on Google+Tweet about this on TwitterPin on PinterestShare on LinkedInDigg thisShare on TumblrShare on RedditEmail this to someone

Leave a Reply

Your email address will not be published. Required fields are marked *