Earlier this month, the Food and Drug Administration (FDA) announced that it will now require Johnson & Johnson to add new warnings regarding the potential risk of side effects for users related to Type 2 diabetes drugs Invokana and Invokamet (canagliflozin) after newer, updated data demonstrated a far greater risk than previously thought.
Invokana Bone Fracture Lawsuits
In the FDA statement announcing the increased warnings, the agency noted that they had concerns that side effects of the two drugs may include a risk of bone density loss even before they approved the drug and it was introduced in March 2013, but there were no warnings about bone fracture in either the “Highlights of Prescribing Information” or in the “Warnings and Precautions” sections; there was simply a small mention in the “adverse reactions” section of the drug label, saying that bone fractures were possible. Since then, however, updated clinical trial data demonstrates a far more certain link between Invokana and bone fractures, which is why they’re requiring Johnson & Johnson to strengthen the warnings.
Data from several recent studies suggest that fractures occur more frequently with canagliflozin than a placebo, and that the increased risk of fracture can occur as little as 12 weeks after starting treatment with the drug. The clinical trials demonstrated that even minor trauma can cause a fracture, including simply falling from a standing height. In addition to the clinical trials, the FDA also received additional information about the nature of the bone density loss related to Invokana and Invokamet, when a study of 714 elderly patients demonstrated that those taking Invokana and Invokamet saw loss of bone density in the hip and lower spine that was not present in those patients who were given a placebo.
The FDA will now require that the label for Invokana contain much stronger bone fracture warnings and that those warnings be placed prominently in the “warnings and precautions” section of the label. They are continuing research, but they have not yet named any other drugs that will be required to carry these warnings, because they have not yet determined whether the risk of bone fracture and bone density loss is also present in other Type 2 diabetes medications in the same class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, a group which includes drugs like Farxiga, Xigduo XR, Jardiance and Glyxambi.
A number of lawsuits are being considered with regard to Invokana, because there seems to be evidence that the drug manufacturer, Johnson & Johnson, appears to have been aware of the potential bone fracture side effects of the drug even before they asked the FDA for approval. It’s entirely possible that, instead of providing accurate information for the medical community and consumers, the drug maker may have placed their quest for profits ahead of patient safety by minimizing the risk and providing everyone with warnings that were potentially misleading.
Invokana Side Effects Lawyers
The drug defect lawyers at Raizner Slania are evaluating potential claims for those users of Invokana and Invokamet who perhaps suffered a bone fracture, which could include spinal fractures, as a side effect of their treatment using this medication. If you have taken one of these drugs, please contact the firm so that we can take a look at the circumstances and see if there is a potential claim to be made.