The injectable glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide (Zepbound) has been approved by the FDA for treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity. It is the first drug to be approved in the US for this indication. Zepbound is also approved for chronic weight management in adults with obesity and in those who are overweight and have at least one weightrelated comorbidity. Tirzepatide is also available as Mounjaro for treatment of type 2 diabetes.

The FDA has approved a new formulation of glucagon (Gvoke – Xeris) for subcutaneous treatment of severe hypoglycemia in patients ≥2 years old with diabetes. Conscious patients with symptoms of hypoglycemia can take oral glucose. Glucagon is usually administered by a caregiver to an unresponsive patient. The new formulation is available in a single-use prefilled syringe (Gvoke PFS) and is expected to become available in a single-use auto-injector (Gvoke HypoPen) in 2020. Unlike previously available injectable glucagon products (Glucagon Emergency Kit, and others), Gvoke does not...

Lispro insulin (Humalog - Lilly), a synthetic insulin analog, has been approved for marketing by the US Food and Drug Administration. Prepared by recombinant DNA methods using E. coli, lispro differs from human insulin in having lysine and proline at positions 28 and 29 on the beta-chain, reversed from their natural position. The new drug has biologic effects similar to unmodified insulin, but is absorbed more rapidly after subcutaneous injection.

The FDA has approved Juvisync (Merck), a fixed-dose combination of the antihyperglycemic DPP-4 inhibitor sitagliptin (Januvia) and the HMG-CoA reductase inhibitor simvastatin (Zocor, and others).

The July 2003 edition of the Canadian Adverse Reaction Newsletter, published by Health Canada (the Canadian FDA), reported that the Health Canada database had received more spontaneous reports of hypoglycemia (19) and hyperglycemia (7) with gatifloxacin (Tequin) than with other quinolone antibiotics.

Insulin aspart (Novolog - Novo Nordisk) is the second rapid-acting insulin analog to be approved by the FDA. The first was insulin lispro (Humalog). Insulin aspart differs from human insulin by substitution of aspartic acid for proline in position 28 on the beta-chain.

Patients may be asking about reports in the lay press that exenatide (Byetta - Med Lett Drugs Ther 2005; 47:45), a synthetic peptide that stimulates release of insulin from pancreatic beta cells, has been used by diabetics and non-diabetics to lose weight. Approved by the FDA to improve glycemic control in patients with type 2 diabetes not controlled by metformin, a sulfonylurea or both, it is given by subcutaneous injection before the morning and evening meals. In clinical trials, some diabetic patients treated with the drug lost weight. No data are available on use in non-diabetics....

In 2013 the FDA approved one new drug and a new combination of 2 old drugs as adjuncts to lifestyle changes for chronic weight management. Lorcaserin (lor-ca-SER-in; Belviq – Arena/Esai) is a selective serotonin 2C receptor agonist. Qsymia (Vivus) is a fixed-dose combination of the weight-loss drug phentermine and an extended-release (ER) formulation of topiramate. The new products are approved for use in obese patients (body mass index [BMI] of ≥30 kg/m2) and for patients who are overweight (BMI ≥27 kg/m2) and have one weight-related risk factor such as hypertension, dyslipidemia or...

The FDA has approved dasiglucagon (Zegalogue – Zealand) for subcutaneous (SC) treatment of severe hypoglycemia in patients ≥6 years old with diabetes. Dasiglucagon is the third glucagon product to be marketed in the US that does not require reconstitution before administration; Gvoke, a SC formulation approved for use in patients ≥2 years old, and Baqsimi, an intranasal powder approved for use in patients ≥4 years old, have been available since 2019. Injectable glucagon emergency kits (GlucaGen HypoKit, and generics) have been available for years, but they require...

An FDA advisory committee has voted in favor of approving ezetimibe/simvastatin (Vytorin – Merck) for prevention of major cardiovascular events in patients with chronic kidney disease who are not on dialysis. The FDA itself is expected to make a decision on this potential new indication in the first quarter of 2012.The manufacturer’s application for this new indication was based on a double-blind, randomized trial (SHARP) that compared the combination of ezetimibe 10 mg and simvastatin 20 mg with placebo in 9270 patients with chronic kidney disease who did not have a history of myocardial...