Bone Fracture Side Effects Warning Gives Support To Invokana Lawsuit Plaintiffs

May 04, 2016 – – TheProductLawyers.com comments on recent FDA action in connection to Invokana and Invokamet. The drugs are part of a group known as SGLT2 class inhibitors, specifically designed to assist individuals with type-2 diabetes in maintaining healthy blood glucose levels. However, the latest call from the FDA is a direct response to the many adverse event reports connecting the drugs to a heightened risk of reduced bone mineral density and risk of fracture in individuals taking them as part of a management regimen.

After a thorough review of the available data, the FDA noted that such fracture events often resulted from falls that could be deemed low trauma. Additionally, they commented, “Fractures were observed as early as 12 weeks after treatment initiation…and affect the upper extremities.” Another study reviewed by the FDA involved 714 patients of advanced age. Results indicated that those taking the SGLT2 class inhibitor experienced a loss of bone mineral density of the hips and lower spines in statistically significant numbers, as compared to those taking a placebo. While this risk surfaced in the drug manufacturer’s own trials and was originally a part of the drug’s warning label, the FDA requested stronger and more visible warnings be incorporated.

The FDA originally approved Invokana for use in 2013. The first of an entire class of drugs designed to regulate blood glucose, Invokana is known as an SGLT2 class inhibitor drug because of how it acts within the body. It is intended to assist individuals with type-2 diabetes with blood glucose management and does so in a different way than previous solutions. Diverting a portion of glucose from the bloodstream to the kidneys, it then inhibits the reuptake of that sugar, which is then directly eliminated via urination. While it is effective in this manner, such processes place intensive stress upon the renal system. Direct processing of glucose is not an original function of the kidneys or bladder, and there is an associated potential for damage to the renal system.

For more information about the Invokana lawsuits, or this press release, please contact TheProductLawyers.com on 888-997-3792.

###

Contact TheProductLawyers.com:

Banville Law
888-997-3792
info@banvillelaw.com
165 West End Ave #1h,
New York, NY 10023

ReleaseID: 60009754