F.D.A. authorises New Hot Flash Treatment Medication

By  Christina Jewett

 Highly News

The first nonhormonal treatment for menopausal women's hot flashes was authorised by the US Food and Drug Administration on Friday, presenting a potential cure for the symptoms of excessive perspiration and higher body heat that can interrupt everyday living for years.

The Veozah medication is the first to target a brain cell that falls out of balance as oestrogen levels drop. According to Marci English, the vice-president of Astellas Pharma, the drug's manufacturer, it would normally be recommended for women in their 50s throughout the midlife phase, which is thought to last seven years.

The medicine was approved by the federal government for mild to severe complaints.

Why It is Important: There are not many safe countermeasures.

Periodic excessive heat is a typical menopausal symptom that Astellas estimates affects at least 60% of women.

"Hot flashes as a result of menopause can be a serious physiological burden on women and impact their quality of life," said Dr. Janet Maynard, a representative of the Food and Drug Administration's Centre for Drug Evaluation and Research.

They may last for a long time and obstruct routine everyday activities.

Years ago, testosterone and progestin therapies were related to raised hazards of blood clots and strokes, but more recent research has shown that these risks are much reduced among women in their 40s and 50s.

Background: Symptoms have been was suffering for a while.

According to Astellas, the most usual menopausal side effect for which women frequently seek therapy is hot flashes.

And in the workplace and elsewhere, menopausal symptoms like severe hot flashes and other problems are frequently ignored.

It's annoying, remarked Ms. English. "It's unpleasant. It's an issue we sort of got by with in quiet.

The medicine was shown to be efficient and usually safe throughout the course of year-long research, with adverse effects including lack of sleep, diarrhoea, and stomach discomfort.

The FDA advised patients to have blood work done before starting a prescription to test for pre-existing liver abnormalities, and then repeat the tests within the first nine weeks of using the medication, since evidence of liver damage occurred in some individuals during the drug's research.

The F.D.A. statement advises patients who have signs of liver damage, such as nausea, vomiting, or yellowing of the skin and eyes, should see a medical professional.

Next: The cost of the medication can be too high.

As stated by Astellas, the medication would cost $550 for a 30-day supply, excluding discounts. The organisation said that it will launch a support programme "to help patients access the medication they were prescribed." A reduced price of $2,000 to $2,600 per year has been suggested by the Institute for Clinical and Economical Review.

Astellas, according to Ms. English, was ready to have the drug available in pharmacies three weeks after receiving permission from them.