Diabetes is a serious condition affecting millions of Americans. The condition often requires those who suffer from it to take medications. Recently, some of these medications have been the subject of medications requiring label updates by the Food and Drug Administration.
The FDA released a safety communication involving the diabetes drug canagliflozin. The safety issue is related to an ongoing clinical trial that revealed an increase in foot and leg amputation among patients who take the drug.
The study, which is known as the Canagliflozin Cardiovascular Assessment Study, discovered that amputations occur approximately twice as often in patients taking the drug as compared with those who took a placebo. While it is not clear that canagliflozin is the primary cause of the amputations, the FDA has entered into an ongoing investigation and the public will be notified once more information is obtained.
Canagliflozen is available under the brand names Invokana and Invokamet. It is a sodium-glucose co-transporter-2 inhibitor prescribed for patients with type-2 diabetes. The drug works by forcing the kidneys to excrete sugar in urine.
This is not the first time that the manufacturers of Invokana, Johnson & Johnson have come under FDA scrutiny for the drug. In 2015, the FDA required a label update for Invokana and several other SGLT2 inhibitors. The updates were required after the FDA learned there was an alleged link between the class of drug and ketoacidosis, a complication of diabetes that causes a high production of blood enzymes called ketones as well as urinary tract infections.
The FDA has advised patients to immediately report any signs or symptoms of pain, tenderness, sores, ulcers, or infections in their legs or feet. The agency is also recommending that health care professionals and patients report any side effects involving canaglifloxin to the FDA MedWatch Program.
If you have suffered from a complication or injury due to taking the prescribed diabetes drug canaglifloxin, you may be entitled to compensation. Contact the law offices of John Foy & Associates today. The “Strong Arm” attorneys will help you get the compensation you deserve. Contact us today.