Invokana and Bone Fractures
The recent FDA warning issued against doctors prescribing Invokana (canaglifozin) due to its adverse side effects including bone fractures is a major setback for its manufacturer and marketers. The warning issued by the Food and Drug Administration indicate that the prescription medication is related to the increase in potential risks of bone fractures and adverse effects on the patient’s bone mineral density.
Invokana was first approved by the FDA in 2013 as an effective drug for treating type II diabetes. Even at the time of its approval in the U.S., other serious adverse effects including increased risks of heart attack, ketoacidosis and kidney damage we already known. By October 2015, the US FDA strengthen the warnings for the canaglifozin medicine (Invokana, Invokamet) by revising the drug’s adverse reactions information, but stopped short of advising patients to stop or change their diabetes prescription medication without first talking to their doctor.
Both Invokana and its generic prescription medication equivalent canaglifozin are thought to lower blood sugar levels in adult patients suffering with Type II diabetes. To be most effective, the medicine is to be used in conjunction with exercise and diet. The drug is classified as a sodium-glucose co-transporter-2 (SGLT2) inhibitor. The medication was developed to provide effective treatment for patients suffering with type II diabetes so they could avoid serious problems including kidney and nerve damage, blindness and heart disease.
Recent Study Findings
Data received from safety evaluations performed after the drug was marketed to consumers indicate additional adverse reactions to Invokana. The study involved 714 elderly patients who were tested over two years to determine if there was any change to their bone mineral density. The findings indicate that numerous patients developed fractures as early as three months after starting to take the drug. The studies indicate that the medication caused a loss of the patient’s bone mineral density in the lower spine and hip that have the potential of accelerating the process of developing osteoporosis. Post-menopausal women seem to be at most risk for bone fractures.
Because of recent findings, the Food and Drug Administration is continuing to investigate the connection between developing bone fractures and the use of SGLT-2 inhibitors. Doctors are advised to take caution when prescribing the medication to patients and to discuss the increased potential risk of bone fractures should they decide to take the drug.
The FDA is updating the prescription medication label so it includes new information concerning the incident rate of bone fractures and the potential risks involved in decreasing patient bone mineral density. In addition to making label changes on Invokana, Invokamet and canaglifozin prescriptions, the FDA is also evaluating the potential risks of developing bone fractures while using other medications categorized in the same class. Some of these include dapagliflozin (Xigduo XR, Farxiga) and empaglifozin (Synjardy, Glyxambi, Jardiance) so it can make a determination if those labels should be changed too.
Taking Financial Steps
In an effort to obtain the most profits, pharmaceutical companies and marketers will quickly rush new drugs to market before they had been adequately tested, which often places consumers in grave danger. In recent months, there have been significant concerns over the efficacy and safety of Invokana and the adverse side effects it produces.
Currently, no class-action suits of been filed against the drug manufacturer Mitsubishi Tanabe Pharma and its marketer Janssen Pharmaceuticals. However, Rosenfeld Injury Lawyers have filed individual lawsuits and claims for compensation on behalf of clients who have suffered injuries caused by Invokana and other Type II diabetes medications that have caused harm, damage, injury or death. Many of the claims against bad drug companies are built on successful legal theories including:
- Manufacturing a dangerous defective drug,
- Failure to warn consumers of the potential risks and side effects of using the medication,
- Negligence, and
- Misrepresenting the risks versus benefits of using a harmful prescription medication.
If you, or a loved one, have suffered injuries, damages or losses by taking Invokana (canaglifozin) or any other defective drug, we encourage you to call our law offices today at (888) 424-5757 to schedule a no-obligation, free initial consultation. Our team of attorneys can ensure you receive adequate recompense to cover your hospitalization costs, medical bills and money lost from time away from work.