Here’s a quick look at what the FDA was up to while we were away last week:
New hot flash therapy: The agency approved the first nonhormonal treatment for hot flashes in menopausal women. Brisdelle contains 7.5 mg of paroxetine, lower than the doses used to treat depression, anxiety, and other psychiatric conditions. The pill is taken once daily at bedtime. Like other formulations of paroxetine, Brisdelle’s label includes a boxed warning noting an increased risk for suicidality.
Olmesartan warning: The antihypertensive medication olmesartan, an angiotensin-receptor blocker marketed as Benicar, Azor, and others, can cause spruelike enteropathy, the FDA warned. Providers should counsel patients to contact them if severe diarrhea with substantial weight loss occurs, even if symptoms develop years after starting the drug.
Estarylla recall: One lot of the combination oral contraceptive Estarylla (norgestimate and ethinyl estradiol) has been recalled after a consumer found a placebo pill in a row of active tablets. The lot number is LF01213A.
Source: FDA news