Restrictions lifted on rosiglitazone medications
According to the FDA, the Risk Evaluation and Mitigation Strategy for rosiglitazone-containing type 2 diabetes mellitus medications is no longer necessary to ensure that the benefits of the drug outweigh the risks.
The FDA removed the prescribing and dispensing restrictions for rosiglitazone medications in 2013 after determining that the data from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes trial did not demonstrate an increased risk of myocardial infarction with rosiglitazone compared with metformin and a sulfonylurea.
The FDA has continued to monitor these medications and has identified no new pertinent safety information.
New drug treats hyperuricemia in gout
Lesinurad (Zurampic, AstraZeneca) was approved to treat hyperuricemia associated with gout when used in combination with a xanthine oxidase inhibitor (XOI). Lesinurad helps the kidneys excrete uric acid by inhibiting the transporter protein function involved in uric acid reabsorption in the kidney.
The FDA's approval was based on the results of three clinical trials of lesinurad in combination with a XOI in over 1,500 participants for up to 12 months. The studies showed that participants treated with lesinurad in combination with a XOI experienced reduced serum uric acid levels compared with placebo.
The most common adverse reactions reported in clinical trials of lesinurad were headache, influenza, increased blood creatinine, and gastroesophageal reflux disease.
FDA approves insulin glargine
The FDA approved Eli Lilly's insulin glargine injection (Basaglar) to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Basaglar is administered subcutaneously with the manufacturer's KwikPen injector once daily at any time of day as long as it is given at the same time every day. Dosing is based on individual patient needs.
The long-acting human insulin analogue demonstrated that it was similar enough to Lantus (another insulin glargine injection on the market) to scientifically justify its approval. Eli Lilly also submitted data specific to Basaglar to further establish its clinical credentials, including data from two clinical trials.
Basaglar may cause hypoglycemia, which can be life threatening. Patients should be monitored more closely when changes are made to the insulin dosage, with coadministration of other glucose-lowering medications, changes in meal pattern or physical activity, and in patients with kidney dysfunction, hepatic impairment, or hypoglycemia unawareness.
The most common adverse reactions associated with Basaglar in clinical trials include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.
Warnings issued for SGLT2 inhibitors
Sodium-glucose cotransporter-2 (SGLT2) inhibitors, such as empagliflozin (Jardiance), dapagliflozin (Farxiga), and canagliflozin (Invokana) must add new product label warnings concerning the risks of ketoacidosis and urinary tract infections (UTIs), according to a new FDA communication.
An agency safety review of these medications found 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes mellitus who were treated with SGLT2 inhibitors and 19 life-threatening cases of urosepsis and pyelonephritis that developed following a UTI. All 19 patients with urosepsis and pyelonephritis were hospitalized, and several were admitted to the ICU or the dialysis unit for kidney failure treatment.
The FDA said some reports identified a concurrent event associated with ketoacidosis, such as dehydration, infection, and reduced insulin dose. Healthcare providers should consider these risk factors prior to prescribing SGLT2 inhibitors. If patients complain of symptoms after taking these medications, they should be formally evaluated. The SGLT2 inhibitor should be discontinued and treatment instituted promptly if ketoacidosis is suspected.