The United States Food and Drug Administration (FDA) approved a new generic medication to treat certain symptoms of menopause and prevent osteoporosis in postmenopausal women: it is a hormonal patch that is applied once a week and contains a combination of estrogen and progestin.
The authorization, officially announced by the FDA on Tuesday, pertains to the first generic of Climara Pro, developed by Zydus Pharmaceuticals (USA) to relieve moderate to severe symptoms of menopause in women who have a uterus.
The treatment consists of a transdermal system that releases two hormones through the skin: estradiol and levonorgestrel, and its weekly application allows for the administration of both substances without the need to take pills daily.
The novelty is that, for the first time, the FDA has authorized a generic version of Climara Pro, a reference medication marketed under a Bayer trademark.
According to the federal agency, the generic is therapeutically equivalent to the original product, meaning that it meets regulatory requirements to provide the same clinical effect and safety profile when used according to its approved indications.
The patch is specifically indicated for the treatment of moderate or severe vasomotor symptoms associated with menopause, including hot flashes or sudden episodes of heat that may be accompanied by sweating, flushing, and sleep disturbances.
It also has approval for the prevention of postmenopausal osteoporosis, a condition characterized by the loss of bone density and strength that increases the risk of fractures.
The presentation approved by the FDA corresponds to a transdermal system of estradiol and levonorgestrel delivering 0.045 milligrams of estradiol and 0.015 milligrams of levonorgestrel daily.
The FDA warns that Climara Pro and its generic version are contraindicated in patients with breast cancer or a history of that disease, certain estrogen-dependent tumors, unexplained genital bleeding, and liver disease or dysfunction.
They are also contraindicated in women with deep vein thrombosis, pulmonary embolism, or a history of these conditions, as well as in patients with active or prior arterial thromboembolic diseases.
The restrictions include certain disorders that promote the formation of blood clots, deficiencies of anticoagulant proteins, and a history of severe allergic reactions to its components.
Among the most common adverse effects identified for Climara Pro and its generic counterparts are reactions at the application site, vaginal bleeding, breast pain, headaches, back pain, depression, upper respiratory infections, and flu-like symptoms.
The decision to use this type of therapy requires an individualized medical evaluation that takes into account the symptoms, personal history, risk factors, and available alternatives.
Menopause is a natural stage of life that occurs when menstrual periods stop due to changes in ovarian function.
Their manifestations vary significantly: some women experience mild discomfort, while others encounter symptoms that interfere with rest, daily activities, and their quality of life.
Among the most well-known manifestations are hot flashes, which can occur during the day or night and lead to episodes of intense sweating.
In September, a Cuban woman in Florida who went viral for jumping into a river to cool off during an episode of hot flashes related to menopause.
The video, shared in a humorous tone, reflected one of the most recognizable annoyances of this phase, although that spontaneous reaction does not constitute medical advice.
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