FDA Okays Low-Dose Local strogen

WASHINGTON — The FDA has approved a low-dose local estrogen therapy, a 10 mcg formulation of the estradiol vaginal tablet Vagifem, for atrophic vaginitis, drugmaker Novo Nordisk announced today

The therapy was first approved in a 25 mcg dose in 1999 Approval for the lower dose was based on a 52-week randomized, placebo-controlled multicenter trial with 309 participants with an average age of 576

Women using the estradiol tablets showed statistically significant improvement after 12 weeks of treatment compared with those using a placebo in:

orrecting vaginal pH -13 versus -04, P<0001orrecting vaginal maturation index in parabasal cells: -37% versus -9%; in superficial cells: 13% versus 4%; in intermediate cells: 24% versus 5%; P<0001 for all Symptom score -123 versus -087, P=0003

The tablet was shown safe and well tolerated by patients after one year of treatment

Placebo and treatment patients experienced adverse events in about the same proportions, and more than half of the event were mild to moderate

The most common side effects among patients using the estradiol tablets were vulvovaginal mycotic infection, back pain, and vulvovaginal pruritus

Serious side effects occurred in six patients 23% on active treatment and in two 19% on placebo — chief among them, pneumonia, infraorbital squamous cell carcinoma, endometrial adenocarcinoma stage 2, grade 2, centricular extra systoles, gallstones, and gallbladder inflamation

Side effects associated with estrogen treatment in general include increased risk of uteral cancer, including vaginal bleeding associated with cancer, stroke, blood clot, headache, breast pain, irregular vaginal bleeding or spotting, stomach and abdominal cramps, bloating, nausea, hair loss, fluid retention, and yeast infection

Patients taking estrogens with progestins may face an increased risk of myocardial infarction and breast cancer

Patients 65 and older may be at increased risk of developing dementia while on estrogens with or without progestins

source : ww.medpagetoday.com/OBGYN/Menopause/17314″ rel=”nofollow”>www.medpagetoday.com

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