Diabetes Medications Updates
Last year, the FDA released a drug safety communication, which cautioned the use of SGLT2 inhibitors, due to case reports of ketoacidosis in patients who were being treated with these medications. Recently, the FDA has updated the labels for SGLT2 inhibitors to include the risks for both ketoacidosis and serious urinary tract infections. Patients in these case reports were found to start with urinary tract infection, which then progressed to potentially fatal urosepsis and pyelonephritis that required hospitalization or dialysis to treat kidney failure. Patients who continue to take these medications should be taught to recognize the symptoms of ketoacidosis, which include nausea, vomiting, abdominal pain, fatigue and difficulty breathing. Ketoacidosis can occur even if their blood glucose is not excessively high. Patients with suspected ketoacidosis should stop taking the SGLT2 inhibitor and receive treatment promptly. Clinicians are encouraged to report any side effects to the FDA MedWatch program.
SGLT2 inhibitor is a class of diabetic medication that works by stopping glucose from being reabsorbed into the blood. Medications in this class include Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin).
The FDA imposed the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetic medications in 2010 due the concern of possible increased cardiovascular risk. It required healthcare providers to obtain a special certification in order to prescribe rosiglitazone and patients receiving rosiglitazone must be enrolled in the REMS program. In 2013, the FDA lifted the restrictions for the prescribing and use of rosiglitazone based on the data from RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) trial. The RECORD trial demonstrated no elevated cardiovascular risk. Recently, the FDA has lifted the entire REMS requirements for rosiglitazone-containing medications, which includes Avandia (rosiglitazone), Avandamet (rosiglitazone-metformin) and Avandaryl (rosiglitazone-glimepiride) on the basis of post-marketing data and the RECORD trial. However, most of these medications have either been removed from the market (Avandamet and Avandaryl) or are rarely used in patients (Avandia).
The FDA gave final approval in December 2015 to Basaglar (a copycat version of insulin glargine). Basaglar was not approved as a “biosimilar” product although it was demonstrated to be similar enough to another insulin glargine on the market (Lantus) regarding its effectiveness and safety. It is administered subcutaneously with the manufacturer’s KwikPen injector once daily at any time of the day. Being as the first “follow-on” insulin glargine product, Basaglar received much attention for potentially lower costs. Basaglar has already launched in the UK under the brand name of Abasaglar and is priced 15% lower than Lantus (listed price of £35.28 for Abasaglar and £41.50 for Lantus according to UK Medicines Information). Pricing for Basaglar in the US is unknown at this time and the drug will not be available until after December this year.
- FDA. FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. Accessed on January 10, 2016.
- FDA. Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication – FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS). Accessed on December 28, 2015.
- FDA. FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes. Accessed on December 28, 2015.