Department: Medication Update
Tretinoin topical lotion approved for acne
The FDA approved tretinoin (Altreno) 0.05% topical lotion for treating acne vulgaris in patients 9 years of age and older. It is the first tretinoin product to be available in lotion form. Tretinoin topical lotion is a product of Ortho Dermatologics.
According to the company, the drug is formulated to enhance users' experiences with the inclusion of moisturizing attributes of sodium hyaluronate, glycerin, and collagen; it spreads easily and is quickly absorbed into the skin.
In randomized, double-blind, vehicle-controlled trials involving 1,640 patients age 9 years and older with mild-to-moderate acne, tretinoin topical lotion demonstrated the efficacy of tretinoin with reductions in both inflammatory and noninflammatory lesions compared with the vehicle. The most common adverse reactions reported in equal to or greater than 1% of the patients and greater than vehicle were dryness, pain, erythema, irritation, and exfoliation.
Sunscreen and protective clothing should be worn when sun exposure cannot be avoided. Tretinoin topical lotion should be used with caution if the patient is allergic to fish because of the potential for allergenicity to fish protein.
FDA clears generic potassium chloride oral solution
The FDA approved several strengths of potassium chloride oral solution as the first generic drug to receive a competitive generic therapy (CGT) designation. CGT designation is a new approval pathway created to expedite the development and review of generic drugs for products that lack generic competition, to help address the high cost of drugs, and to reduce the amount of time it takes for generics to reach the market. Potassium chloride oral treatment is indicated for the treatment and prevention of hypokalemia. The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain or discomfort, and diarrhea.
Sarecycline approved for moderate-to-severe acne
Sarecycline (Seysara) was approved for patients age 9 and older with inflammatory lesions associated with nonnodular moderate-to-severe acne vulgaris. The once-daily oral tablet is a product of Almirall. The recommended dosage is weight-based and may be given with or without food. Sarecycline is a new first-in-class tetracycline-derived oral antibiotic and the first designed specifically for dermatologic use in 40 years, according to Almirall. The drug has anti-inflammatory properties.
In clinical trials assessing its efficacy in 2,002 patients, the drug was found to be safe and effective, significantly reducing inflammatory lesions as early as 3 weeks after starting treatment. The trials have not established efficacy beyond 12 weeks nor safety beyond 12 months. Sarecycline was not evaluated for treating infections. Sarecycline is contraindicated in patients who are hypersensitive to any of the tetracyclines. The drug may cause permanent tooth discoloration if used during tooth development. Nausea is the most common adverse reaction. Consult product labeling for prescribing precautions.
FDA warns of infection associated with SGLT2 inhibitors
The FDA is warning that cases of a rare and serious infection—Fournier gangrene (necrotizing fasciitis of the perineum)—have been reported with the class of type 2 diabetes mellitus medications called sodium-glucose cotransporter-2 (SGLT2) inhibitors. The agency requires a warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.
Examples of SGLT2 inhibitor medications include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. The FDA advises healthcare providers to assess patients for Fournier gangrene if they present with symptoms including tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum or if they have a fever above 100.4° F (38° C) or a general feeling of being unwell. Symptoms can worsen quickly, so providers must initiate prompt treatment. If suspected, treatment should be started immediately with broad-spectrum antibiotics and surgical debridement if necessary. The SGLT2 inhibitor should be stopped, blood glucose levels should be closely monitored, and alternative therapy for glycemic control initiated.