Drug approved for endometriosis pain
The FDA approved elagolix (Orilissa), the first gonadotropin-releasing hormone antagonist specifically developed for the treatment of moderate-to-severe pain associated with endometriosis, and the first FDA-approved oral treatment for the management of moderate-to-severe pain associated with endometriosis in over a decade. Elagolix, a product of AbbVie, was approved under the FDA's priority review.
The FDA approved elagolix based on data from two studies involving nearly 1,700 women with moderate-to-severe endometriosis, which demonstrated that elagolix significantly reduced the three most common types of pain from endometriosis: daily menstrual pelvic pain, nonmenstrual pelvic pain, and pain with sex. A higher proportion of women treated with elagolix were responders for daily menstrual pain and nonmenstrual pelvic pain compared with placebo in a dose-dependent manner at 3 months.
Elagolix is dosed at 150 mg once daily or 200 mg twice daily with or without food. It should be taken at approximately the same time each day. The recommended duration of use of elagolix is up to 24 months for the 150 mg once-daily dose and up to 6 months for the 200 mg twice-daily dose, as it causes a dose-dependent decrease in bone mineral density (BMD). Loss of BMD is greater with increasing duration of use and may not be completely reversible after stopping the drug, according to AbbVie. Dosage adjustments are also required for women with moderate hepatic impairment.
FDA announces recall of valsartan-containing medications
The FDA announced a voluntary recall of several medications containing valsartan following detection of N-nitrosodimethylamine, an impurity that is a probable human carcinogen. The FDA states that the five recalled products are the only valsartan products involved in the recall because not all valsartan-containing medications distributed in the US use the valsartan active pharmaceutical ingredient (API) supplied by Zhejiang Huahai Pharmaceuticals of Linhai, China, which is the subject of the recall.
Recalled valsartan medications and manufacturing companies
* Valsartan (Major Pharmaceuticals)
* Valsartan (Solco Healthcare)
* Valsartan (Teva Pharmaceuticals Industries Ltd.)
* Valsartan/Hydrochlorothiazide (Solco Healthcare)
* Valsartan/Hydrochlorothiazide (Teva Pharmaceuticals Industries Ltd.)
Zhejiang Huahai has stopped distributing its valsartan API, and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.
Asthma inhaler approved for children 5 and older
Fluticasone furoate (Arnuity Ellipta) inhaled corticosteroid is now approved by the FDA for use as a once-daily asthma medication for patients age 5 years and older. Fluticasone furoate is a product of GlaxoSmithKline. The use of fluticasone furoate in children ages 5 to 11 years was supported by data from a safety and efficacy trial that compared once-daily dosing of fluticasone furoate versus placebo in 593 children with asthma.
The 12-week trial showed statistically significant improvement in peak expiratory flow with fluticasone furoate over placebo. The safety profile of the drug in children ages 5 to 11 is consistent with the known safety profile of the drug, according to GlaxoSmithKline. The most common adverse reactions reported in children are pharyngitis, bronchitis, and viral infection.
Fluticasone furoate is contraindicated for primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures and in patients with severe hypersensitivity to milk proteins. Consult product labeling for prescribing instructions.