FDA Safety Advisories about Diabetes Medication Invokana and Invokamet
The U.S. Food and Drug Administration has issued a new drug safety warning about the potential risks of bone fractures and decreases in bone density associated with the diabetes drugs Invokana and Invokamet, a combination therapy. The FDA has required the manufacturer to strengthen the warnings on the drugs label.
Invokana (canagliflozin), which has been on the market since 2013, is the first member of a new generation of diabetes medications known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Invokamet is a therapy that combines the active ingredient in Invokana and metformin, a type 2 diabetes drug.
The FDA said in a statement that there were concerns before Invokana was approved that the side effects of Invokana could include a risk of loss of bone density. But the risk of bone fractures received only a small mention on the drug’s warning label.
The FDA required the drug manufacturer Johnson and Johnson to conduct a clinical trial on changes to bone density over a two-year period. The study of more than 700 elderly patients showed that those given the diabetes drugs experienced a greater loss of bone mineral density in the spine and hips than patients taking a placebo. Loss of bone mineral density weakens bones and increases the risk of fractures.
The FDA said that updated data from clinical trials makes a stronger association between Invokana and bone fractures, prompting the agency to require that new warnings be added to the drug label of the type 2 diabetes drugs containing the active ingredient canagliflozin. The new warning states in part that, “Fractures can occur as early after 12 weeks after starting the drug.”
From July 2014 through June 2015, approximately 1.1 million patients received canagliflozin prescriptions and 41,000 patients received prescriptions for Invokamet combination therapy, according to the FDA.
Invokana Side Effects Requiring Hospital Treatment
The FDA announcement follows an earlier safety announcement in May, warning that Invokana may cause a serious medical condition in which the body produces high levels of blood acids called ketones requiring hospitalization. The condition is known as ketoacidosis.
Invokana is a prescription medication used in conjunction with diet and exercise to lower blood sugar in adults with type 2 diabetes, the most common form of the disease. The drug is manufactured by Johnson & Johnson’s Janssen Pharmaceuticals, Inc.
Invokana Side Effects Requiring Hospitalization
The FDA said that investigators have identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis or ketosis in patients taking SGLT2 inhibitors during the period from March 2013 to June 2014. The FDA said all the patients required emergency room treatment or hospitalization to treat the ketoacidosis.
Since June 2014, the FDA said it had received additional reports of patients treated with SGLT2 inhibitors. The FDA is continuing to investigate the safety of Invokana and will determine whether revisions need to be made in the prescribing information for this class of drugs.
Patients who are taking Invokana and experience symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion or unusual fatigue should be evaluated by a medical doctor for the presence or acidosis.
Contact Our Raleigh Product Liability Attorneys
If you or someone you know was prescribed Invokana and has been diagnosed with Ketoacidosis, you may want to contact a Raleigh product liability attorney experience at handling cases involving drug side effects. Anyone injured by side effects of a prescription medication may have a right to seek compensation. Our attorneys are reviewing new cases of those injured by Invokana and are ready to assist. We can be reached at 1-800-738-0448 or contact us online through our website at www.lawyernc.com.