Invokana Lawsuit Filings Combined With Recent FDA Bone Fracture Warnings Cause Concern Over Drug
March 23, 2016 – – TheProductLawyers.com reports on recent side effect warnings provided by the U.S. Food and Drug Administration which discuss two similar new-generation diabetes drugs: Invokana and Invokamet. The drugs are both SGLT2 class inhibitors, and the FDA has now noted that after receiving many adverse event reports detailing bone fracture side effects among patients using the drugs, there are new concerns and safety warnings.
According to reports, the drugs have been connected to a substantial decrease in bone density as well as an increased risk of bone fractures. Although the warning labels on these drugs have indicated possible bone fracture risks since their debut to market in 2013, the FDA is now requiring changes to these warnings in order to better reflect new concerns.
Regarding the adverse event reports, the FDA noted, “Fractures were observed as early as 12 weeks after treatment initiation, and were more likely to be low trauma (e.g., arising after falls from no more than standing height) and affect the upper extremities.” They also discussed a medical study which evaluated 714 elderly patients. Among the patients, it was discovered that those who were taking Invokana had developed increased bone loss in their spines and hips.
The FDA approved Invokana in 2013 to treat type-2 diabetes patients, and it was the first of a group of several similar SGLT2 class inhibitor drugs. Invokana works by helping to maintain blood sugar levels for type-2 diabetes patients. It does this by blocking the kidneys from reabsorbing excess sugar, and instead, using them to remove the sugar from the body via urination. Because the drug works in this fashion, it relies heavily on the kidneys and can put stress on them as well.
In addition to the FDA, bone loss and bone fracture concerns for patients using SGLT2 class inhibitor drugs were also the subject of a warning issued by the Endocrinologic and Metabolic Drugs Advisory Committee. In their warning, the committee discussed bone density loss that was observed during clinical trials on the drugs. Some patients using these drugs have reported breaking bones after suffering just small falls–such as from tripping while walking.
The attorneys of Banville Law are focused on keeping important drug information available to the public. To help facilitate this, they sponsor online resource website TheProductLawyers.com, and are also looking to help any patients who have used SGLT2 class inhibitor drugs and who believe these drugs have caused them to suffer from medical problems. The attorneys of Banville Law understand the importance of helping to ensure that these patients will be provided with the opportunity to fully explore their legal rights. To assist those wishing to seek justice in the matter, they are now offering complimentary legal consultations. Qualifying parties could be entitled to significant compensation through legal action.
To request more information or ask questions, please contact the attorneys of Banville Law by calling 877-671-6480.
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