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Recently, the makers of Invokana, a popular type-2 diabetes drug, have come under legal scrutiny for allegedly causing users to suffer from drug complications such as diabetic ketoacidosis.
However, according to recent reports, the drug has caused other Invokana side effects, including cardiovascular issues such as heart attack and heart failure.
EMDA Conference Regarding Invokana
In January 2013, the FDA Endocrinologic and Metabolic Drugs Advisory Committee (or EMDA) convened a meeting where Janssen Pharmaceutical representatives presented evidence of the increasing number of individuals who are diagnosed with type-2 diabetes among the United States population.
Janssen’s presentation also argued for the need for effective type-2 diabetes treatments and, predictably, promoted the pharmaceutical company’s diabetes medication Invokana (also known as canagliflozin).
However, during the question and answer portion of the this EMDA meeting, Director of Public Citizen’s Health Research Group Dr. Sidney Wolfe commented that Janssen’s request for Invokana FDA approval was “based solely on surrogate efficacy of HbA1c lowering.” HbA1c lowering is a measure of how effectively a patient’s blood sugar is controlled by a diabetes treatment.
During the meeting, Dr. Wolfe went on to say:
“As with all recently approved Type-2 diabetic drugs, [there is] no evidence of any improved clinical outcomes, contrary to an older diabetes drug such as metformin . . . this surrogate efficacy needs to be balanced against a number of serious safety signals identified in the clinical trials.”
Dr. Wolfe’s main concern with Invokana was the risk of “thrombotic events” more commonly referred to as blood clots that could lead to heart attacks for patients using the Janssen diabetes medication.
Based on the Invokana studies presented during the EMDA meeting, Wolfe concentrated on the fact that 13 patients experienced cardiovascular events like heart attack or heart failure while taking Invokana.
The doctor also extrapolated data from study done on a related type-2 diabetes drug class known as gliflozin in order to demonstrate that that the risk of heart attack for Invokana patients may be significantly greater, especially considering “there is much more of an increase in hematocrit in the people getting canagliflozin [Invokana], 1.5 times as much as the dapa [gliflozin] group,” Dr. Wolfe states.
This increase in hematocrit, or red blood cell concentration, is significant, because higher hematocrit levels generally increase a person’s likelihood of developing blood clots, eventually leading to stroke or heart attack.
At this same committee hearing, FDA reviewer Dr. Hyon Kwon testified that there existed “an imbalance in early cardiovascular events” observed by researchers in the early CANVAS trial.
This trial study observed 4,300 patients in order to determine potential Invokana cardiovascular effects. According to supporting testimonies by FDA Biostatistician Dr. Mat Soukoup, this imbalance translates to a cardiovascular hazard ratio of 6.9.
This means that based on these findings, Invokana users are at a 690 percent higher risk of suffering a cardiovascular event like heart attack or heart failure when compared to the placebo control group.
Invokana Litigation
Based on Drs. Wolfe, Kwon, and Soukoup’s testimonies, it would be reasonable to assume that Invokana’s drug makers would have been ordered to perform more studies before their diabetes medication was approved by the FDA for use in the U.S. However, the FDA went ahead with Invokana approval as long Janssen monitored their diabetes treatment for any adverse effects.
If you or someone you know suffered a heart attack, heart failure, or another Invokana side effect after using the Janssen drug, you have legal claims to bring against the pharmaceutical giant.
In general, diabetes medication lawsuits are filed individually by each plaintiff and are not class actions.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.
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If you or a loved one suffered ketoacidosis or kidney failure after taking Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance or Glyxambi, you may have a legal claim. See if you qualify to pursue compensation and join a free diabetes medication class action lawsuit investigation by submitting your information for a free case evaluation.
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