Approval On December 19, 2017, the FDA approved Merck & Co. and Pfizer's new diabetes drug, Steglatro, and its two combination versions, Steglujan and Segluromet. These drugs are classified as sodium/glucose cotransporter 2 (SGLT2) inhibitors, and will be available this coming January. Steglatro consists of ertugliflozin, while Steglujan … [Read more...]
SGLT2 Inhibitors May Have an Increased Risk of Acute Renal Failure
SGLT2 Inhibitors: A New Side Effect In previous articles, I have discussed SGLT2 inhibitor diabetes drugs such as Invokana, Farxiga, and Jardiance and the adverse events associated with them. Such side effects include diabetic ketoacidosis (DKA) and lower-limb amputations. A recent study identified a new possible side effect of these drugs … [Read more...]
J&J Tries to Expand Invokana Label to Include Cardiovascular Benefits
Johnson & Johnson's, the drug manufacturer of diabetes drugs Invokana, Invokamet, and Invokamet XR, recently submitted a supplemental new drug application (sNDA) to the FDA to request expansion of the labels for these drugs. If granted, the new label would include a cardiovascular indication concerning the reduction of risk of cardiovascular … [Read more...]
Type 2 Diabetes Drugs Linked to Severe Joint Pain
Health Canada recently warned about the risk of severe, debilitating joint pain as a result of taking type 2 diabetes medications called dipeptidylpeptidase-4 (DPP-4) inhibitors. This DPP-4 inhibitors class of drugs includes the following: Onglyza Kombiglyze XR Nesina Kazano Oseni Glyxambi Janumet (XR) Januvia … [Read more...]
Federal Court Invokana MDL In New Jersey With Judge Brian Martinotti
Invokana (canagliflozin) was approved by the FDA in 2013. Invokamet (canagliflozin and metformin) was approved by the FDA in 2014. Both of these drugs were approved for use by patients with Type 2 diabetes. In December 2015 the FDA issued this Drug Safety Communication: “FDA revises labels of SGLT2 inhibitors for diabetes to include warnings … [Read more...]
EMA Warns that Some Diabetes Drugs Cause Increased Risk of Amputation
Earlier today, February 10, 2017, the European Medicines Agency (EMA) released the findings of their Pharmacovigilance Risk Assessment Committee (PRAC) concerning the link between particular diabetes drugs and an increased risk of toe amputation. These diabetes drugs are part of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of … [Read more...]