Invokana Bone Fracture Side Effects
The FDA announced this week that it is requiring new warnings about the potential risk that Invokana side effects and Invokamet side effects may increase the risk of bone fractures and lead to decreased bone density.
The product liability lawyers at Saiontz & Kirk, P.A. are currently reviewing potential Invokana lawsuits for individuals throughout the U.S. who have suffered severe ketoacidosis injury or kidney failure, alleging that the drug maker failed to adequately warn about the potential side effects of this popular new-generation diabetes drug.
These new warnings are being closely reviewed to determine if additional individuals may be entitled to financial compensation through an Invokana bone fracture lawsuit.
FDA Bone Fracture Warnings for Invokana, Invokamet
Invokana (canagliflozin) was introduced in March 2013, as a new type of diabetes treatment, which works by inhibiting some normal kidney functions to increase the amount of sugar excreted in the urine. Invokamet was introduced in August 2014, as a combination therapy that includes both Invokana and the older diabetes drug metformin.
On September 10, an FDA Invokana safety announcement was issued, indicating:
The U.S. Food and Drug Administration (FDA) has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures and added new information about decreased bone mineral density. Bone mineral density relates to the strength of a person’s bones. To address these safety concerns, we added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.
Health care professionals should consider factors that contribute to fracture risk prior to starting patients on canagliflozin. Patients should talk to their health care professionals about factors that may increase their risk for bone fracture. Patients should not stop or change their diabetes medicines without first talking to their health care professional.
Our lawyers are extremely concerned that the drug manufacturers appear to have been aware of the potential Invokana bone fracture side effects before the medication was ever approved. However, rather than providing accurate information for consumers and the medical community, the drug maker may have placed their desire for profits before consumer safety by minimizing the risk and providing misleading warnings.
When Johnson & Johnson’s Janssen Pharmaceuticals subsidiary introduced Invokana in March 2013, there were no bone fracture warnings in the “Highlights of Prescribing Information” or in the “Warnings and Precautions” section. However, there was data essentially buried and hidden within the “Adverse Reactions” section, under the heading “Clinical Studies Experience,” which acknowledges that pooled data from eight clinical trials with longer exposure to the drug found an increased incidence of bone fractures with Invokana. It now appears likely that this information was inadequate based on what the drug manufacturer knew or should have known.
More than two years after the drug has been on the market, the FDA is requiring stronger bone fracture warnings be added to the label and placed prominently as a new “Warning and Precaution”. Users and the medical community will now be informed that Invokana or Invokamet fractures may occur as early as 12 weeks after starting treatment.
The agency notes that when a trauma was associated with an Invokana fracture in clinical trials, it was usually minor, such as falling from no more than standing height.
Invokana Bone Fracture Lawsuits
The lawyers at Saiontz & Kirk, P.A. are considering the potential for claims for users of Invokana and Invokamet who may have suffered a bone fracture due to side effects of the medication.
At this time, cases are being reviewed for investigation purposes to determine whether it can be established that the drug maker withheld information about the risk of fractures. To submit information for review as part of the evaluation of this potential litigation, request a free claim evaluation.
Potential Invokana ketoacidosis lawsuits and Invokana kidney failure lawsuits are also being actively pursued for individuals nationwide. Similar claims are also being pursued for users of other new-generation diabetes drugs that are part of the same class of medications, including Farxiga, Xigduo XR, Jardiance and Glyxambi.