FDA Staff: New Diabetes Drug in Clinical Trials May Pose Cardiac Risks


FDA Staff-New Diabetes Drug in Clinical Trials May Pose Cardiac RisksAn emerging diabetes medication under development by Johnson & Johnson has been found to increase bad cholesterol levels in participating patients during clinical trials.

According to Reuters, the U.S. reviewers said that the drug—canagliflozin—may present heart risks based on documents the reviewers posted this week.

Johnson & Johnson is testing canagliflozin for its treatment of Type 2 diabetes, a disorder typically linked with obesity and a sedentary lifestyle; diabetes affects some 370 million people worldwide, and about 90 percent of those cases are diagnosed as Type 2 diabetes, Reuters explained.

The U.S. Food & Drug Administration (FDA) mandates that drug makers developing Type 2 diabetes medications prove their drugs do not increase cardiac risks, including risks for heart attack, said Reuters. In addition to heart risks, the FDA said that use of canagliflozin could also be linked with possible side effects on the kidneys, increased fungal growth in the perineum, and bacterial growth in the urinary tract.

An independent expert panel will review and vote on the safety, efficacy, and approval of canagliflozin on January 10. Reuters pointed out that the agency typically follows panel recommendations. If approved, canagliflozin will be sold under the name Invokana.

Canagliflozin belongs to a new class of diabetes medication—SGLT2 inhibitors—which block reabsorption of glucose by the kidneys and increase glucose excretion in urine to lower blood sugar, Reuters explained. AstraZeneca Plc and Bristol-Myers Squibb Co’s dapagliflozin, a drug in this class, was rejected by the FDA last January over safety concerns involving the liver; Eli Lilly and Co and Boehringer Ingelheim’s, empagliflozin, a similar medication, is in late-stage trials.

Other Type 2 medications have also faced criticism. Actos has been linked in a growing array of lawsuits and medical studies, to bladder cancer. Lawsuits against Actos typically claim that Takeda Pharmaceuticals and Eli Lilly & Co. knowingly hid evidence that showed taking Actos, especially at high doses or for a prolonged period of time, could lead to bladder cancer. The FDA added a Black Box warning to Actos’ safety information that notes taking the drug for more than one year can increase the risk of suffering bladder cancer, a life-threatening disease.

The previous top-selling type 2 diabetes drug, Avandia, was nearly entirely removed from the market by the U.S. Food & Drug Administration (FDA) due to its link to several life-threatening side effects, including heart attack and stroke.

Januvia (sitagliptin) and Byetta (exenatide), prescribed for the treatment of Type 2 diabetes, have also been associated in recent studies and reports of increased risks for pancreatic and thyroid cancers. Some other serious side effects linked to these drugs include low blood sugar; anaphylaxis and other allergic reactions including hives, rash, swelling of face, lips, tongue, and/or throat; acute pancreatitis, and death. Januvia is manufactured by Merck and Amylin Pharmaceuticals makes Byetta; both drugs are glucagon-like peptide-1 based therapies in the class dipeptidyl peptidase-4 (DPP-4) inhibitors. Both medications increase certain natural substances that lower raised blood sugar levels.