FDA Approves Generic Hormone Therapy Patch for Menopause Symptoms

The FDA has approved the first generic version of Climara Pro (Bayer), a once-weekly hormone therapy patch, to treat moderate-to-severe menopausal symptoms and prevent osteoporosis in postmenopausal women, according to a press release from the agency.

The patch delivers 0.045 mg estradiol and 0.015 mg of levonorgestrel daily. The combination helps reduce the risk of endometrial hyperplasia, or abnormal thickening of the uterine lining, which can occur when estrogen is used alone, according to the FDA. 

The approval comes as the demand for menopause hormone therapy has increased, making some estrogen patches harder to find. The FDA said in September that it was working with manufacturers of estradiol patches to increase supplies and help ensure patches remain available to patients.

 The approval is also part of a larger effort from the FDA to make generic medication more affordable and available to patients and increase access to healthcare, according to the release.

The patch is approved for postmenopausal women who have an intact uterus experiencing menopausal symptoms. Patients who have been diagnosed with breast cancer or have a history of breast cancer should not use the medication, according to the release.

The FDA also advises against use in patients with estrogen-dependent neoplasia, active or prior blood clots (such as deep vein thrombosis or pulmonary embolism), active or prior arterial thromboembolic disease, undiagnosed abnormal genital bleeding, liver disease, or known hypersensitivity to the ingredients. 

The most common side effects include site reactions at the site of application, vaginal bleeding, breast and back pain, upper respiratory infection, depression, headache, and flu syndrome, according to the release. 

Article Key Points

• First generic Climara Pro approved for menopausal sx + osteoporosis prevention.
• Once-weekly patch delivers estradiol 0.045 mg + levonorgestrel 0.015 mg daily.
• Progestin component lowers estrogen-induced endometrial hyperplasia risk.
• Indicated for postmenopausal women with intact uterus.
• Avoid with breast cancer, VTE, arterial thromboembolism, liver disease, or unexplained bleeding.

 

 

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Music therapy can be an attractive option to manage menopause symptoms and depressed mood

As researchers continue to seek effective treatment options for menopause symptoms as alternatives to proven pharmacologic solutions, a number of innovative therapies have been shown to improve symptoms.

A new study identifies music therapy as an attractive option, not only to manage menopause symptoms, but also depressed mood. Study results are published online today in Menopause, the journal of The North American Menopause Society (NAMS).

Not every woman's menopause experience is the same. The symptoms can vary, as can their severity and frequency. Some of the more common symptoms include hot flashes, sleep disturbances, depressed mood, vaginal dryness, sexual dysfunction, and joint and muscle pain.

Very little research has been conducted on the effect of music on menopause symptoms. Most studies have focused on other alternative treatments such as hypnosis, cognitive-behavior therapies, meditation, and mindfulness. The idea that music has a healing effect is not new. Rather, it is rooted in ancient cultures that believed music could heal the body and soul.

Why is music so therapeutic? Because it stimulates the secretion of certain neurotransmitters, including dopamine, serotonin, and endorphins and the hormone oxytocin while decreasing the level of circulating stress hormones such as cortisol. These substances play a role in blood pressure, as well as heart and respiratory rates.

Multiple studies show that women may have an increased risk of depression during the menopause transition compared with the premenopausal period. Prior studies have shown that music therapy has helped to improve depressive symptoms in patients with severe psychotic and nonpsychotic mental disorders. Music therapy has also been shown to help prevent postpartum depression.

Until now, however, there is no known study that has investigated the effects of music therapy on menopause symptoms and the risk of depression in menopausal women. Based on the results of this small study, the researchers concluded that listening to music can significantly decrease depression scores and help to reduce the symptoms of menopause in postmenopausal women. These results suggest that music could be used as a nonpharmacologic therapeutic option in the care of menopausal women.

Study results are published in the article "The effect of music therapy on menopausal symptoms and depression: a randomized-controlled study."

This small study highlights the potential beneficial effect of an easy-to-implement, low-cost, low-tech, and low-risk intervention such as music therapy for menopause symptoms, particularly mood symptoms. Although additional research is needed to confirm these findings in larger study populations, there is little downside to adding music therapy to our armamentarium for menopause symptom management."

Dr. Stephanie Faubion, Medical Director, The North American Menopause Society

 

This is only for your information, kindly take the advice of your doctor for medicines, exercises and so on.   

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