New medication approved for type 2 diabetes mellitus
The FDA has approved lixisenatide (Adlyxin), a once-daily injection, to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). Lixisenatide is indicated for the treatment of T2DM in addition to diet and exercise. This glucagon-like peptide-1 receptor agonist is a product of Sanofi-Aventis.
Lixisenatide was evaluated for safety and efficacy in 10 clinical trials that enrolled over 5,400 patients with T2DM. The drug was evaluated both as a stand-alone therapy and in combination with other FDA-approved medications for diabetes, including metformin hydrochloride, sulfonylureas, pioglitazone, and basal insulin. Use of lixisenatide improved hemoglobin A1C levels. In a cardiovascular outcomes trial of lixisenatide or placebo (including more than 6,000 patients with T2DM who were at risk for atherosclerotic cardiovascular disease), lixisenatide use did not increase the risk of cardiovascular adverse events.
Lixisenatide should not be used by patients with type 1 diabetes mellitus or patients with diabetic ketoacidosis. It is not recommended for use in patients with a history of pancreatitis or gastroparesis. The most common adverse reactions associated with lixisenatide are nausea, vomiting, headache, diarrhea, and dizziness. Concomitant use of lixisenatide with a sulfonylurea and/or basal insulin may result in hypoglycemia. Severe hypersensitivity reactions, including anaphylaxis, were reported in clinical trials.
FDA updates warning on fluoroquinolones for systemic use
The FDA has approved label changes to the Boxed Warnings section on the labeling of fluoroquinolone antibacterial drugs for systemic use because they are associated with disabling and potentially permanent adverse reactions, including tendonitis, tendon rupture, peripheral neuropathies, and central nervous system effects. The warning addresses these serious safety issues. The agency also updated other parts of the drug labels, including the Warnings and Precautions and Medication Guide sections.
The FDA directs that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbations of chronic bronchitis, and acute uncomplicated cystitis because the risk of serious adverse reactions generally outweighs the benefits in these patients. Additionally, for some serious bacterial infections, the benefits of fluoroquinolones outweigh the risks, and it is appropriate for fluoroquinolones to remain as an available therapeutic option.
The FDA is continuing to assess safety issues with fluoroquinolones and will provide updates to the public if additional actions are needed.
FDA approves OTC topical gel for acne
The FDA has approved adapalene (Differin Gel 0.1% ), a topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use by individuals age 12 and older. It is applied once daily in a thin layer on affected areas of skin. Differin Gel 0.1% is for external use only and should not be used on damaged skin, including on skin with eczema or sunburn; individuals using the product should not let it contact their eyes, lips, or mouth. Differin Gel 0.1% is distributed by Galderma Laboratories.
Differin Gel 0.1% is the first retinoid to be made available without a prescription for the treatment of acne and is the first new active ingredient approved for treating acne for OTC use since the 1980s.
Women who are pregnant, planning to become pregnant, or breastfeeding should consult their healthcare provider before use. The FDA notes that although there have not yet been adequate and well-controlled studies of the product in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans. However, some other retinoid drugs have been shown to cause birth defects.
A study of absorption of Differin Gel 0.1% shows that when applied daily over a large skin surface area, absorption is limited, thus supporting its safe OTC use.