The U.S. Food and Drug Administration (FDA) has strengthened its warning for Invokana (canagliflozin, Invokamet, Johnson & Johnson/Janssen Pharmaceuticals Inc.) related to the increased risk for bone fractures, and added new information about decreased bone mineral density at the hip and lower spine.
In March 2013, the FDA approved Invokana for the treatment of Type 2 diabetes. Part of a drug category called sodium glucose cotransporter 2 or “SGLT2 inhibitors,” Invokana works by inhibiting the reabsorption of glucose, causing some of it to be flushed away via the urine. This results in a lower blood glucose level for the individual. Since its approval, however, Invokana has been subject to questions and concerns about its potential side effects.
In May 2015, Invokana and Invokamet were included in a warning about serious blood problems linked to use of six diabetes drugs. In a safety alert, the FDA announced receiving 20 reports from March 2013 to June 2014 of diabetic ketoacidosis — a disorder involving elevated levels of blood acids known as ketones — in patients using the six drugs. Regulators said every patient had to be hospitalized or visit the emergency room, and other patients have continued to be affected by diabetic ketoacidosis.
Risk for bone fractures had previously been mentioned in the adverse reactions section of canagliflozin’s label. However, based on new information from several clinical trials, the FDA has added further warning and precaution information. In the clinical trials, as early as 12 weeks after starting the drug, bone fractures occurred in the upper extremities of several individuals. Fractures typically arose from minor trauma such as merely falling from a standing height.
The FDA said it had required Janssen Pharmaceuticals to conduct a clinical test evaluating changes to bone mineral density over two years in 714 elderly individuals; the test showed that canagliflozin caused greater loss of bone mineral density at the hip and lower spine than a placebo. The regulator urged health care professionals to weigh factors that contribute to fracture risk before prescribing canagliflozin. Further investigations on the potential side effects will determine whether changes will be made in the prescribing information for the SGLT2 inhibitors drug category.
The FDA is currently evaluating the possible risk for bone fractures for other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR, AstraZeneca) and empagliflozin (Jardiance, Glyxambi, Synjardy, Lilly/Boehringer Ingelheim), to determine whether additional label changes or studies are needed. If you need more information on this matter, contact Danielle Mason, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Danielle.Mason@beasleyallen.com.
Source: Law360.com; Medscape.com
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.