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New Tymlos Patch StudyThe trial compares Abaloparatide/Tymlos(R) injection vs Tymlos(R) patch. The patch is applied for 10 minutes daily and avoids the need for daily subcutaneous injection.Every woman with osteoporosis who gets enrolled in this study will receive active treatment free of charge in that there is no placebo group. Patients are randomized to either daily injection or patch. The study is 12 months and requires about 14 visits to Cleveland Clinic's main campus. Parking, mileage,…

A dual-acting osteoporosis drug. Minimally invasive mitral valve surgery. New treatment for peanut allergies. These are some of the innovations that will enhance healing and change healthcare in the coming year, according to a distinguished panel of doctors and researchers.Cleveland Clinic announced the Top 10 Medical Innovations for 2020 at a multimedia presentation that capped off the 2019 Medical Innovation Summit. Now in its 17th year, the annual Medical Innovation Summit is organized by…

A new drug to treat most cystic fibrosis patients has been approved by the U.S. Food and Drug Administration.Trikafta (elexacaftor/ivacaftor/tezacaftor) is the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Its list price is $311,000 a year, same as one of the maker's earlier treatments for the genetic disease.Trikafta is approved for patients aged 12 and older who have at least one F508del mutation in the cystic fibrosis…

Authors: Anna Camille Moreno DO NCMP, Belinda L Udeh, Yao Meng, Sabrina Sahni MD and Holly L. Thacker MD The primary objective of this study was to assess the efficacy of APEX M™ pelvic floor therapy, a pelvic stimulating device, for women with urinary incontinence (UI) from April 1, 2014 to January 31, 2018 at a tertiary medical center. Efficacy of the device was measured by daytime incontinence episodes; nighttime incontinence episodes (nocturia); number of female incontinence pads at study…

The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the preventive treatment of migraine.Migraine headache pain is often described as an intense throbbing or pulsing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately…

Another drug has been added to a recall for medication used to treat high blood pressure. Torrent Pharmaceuticals Limited is recalling several batches of Losartan Potassium tablets, the FDA announced Thursday. Losartan is reportedly used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy, and for the treatment of nephropathy in Type 2 diabetic patients. The recall states that “trace amounts” of N-Methylnitrosobutyric acid, which is a known carcinogen, have been…

A substance that could cause cancer has been found in some ranitidine heartburn and ulcer medicines, including the brand-name drug Zantac, and the source of this contamination is being investigated, the U.S. Food and Drug Administration says. While preliminary tests found low levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA) in some ranitidine products, the FDA said this does not mean patients taking the drugs should stop using them now.

Exposure to fluoroquinolone antibiotics is linked to a heightened risk of left-sided valvular regurgitation, analysis of adverse event reporting data showed. Fluoroquinolones overall held a significant 45% higher likelihood of valvular regurgitation events reported to the FDA Adverse Events Reporting Systems (FAERS) than did other drugs from 2004 to 2018, reported Mahyar Etminan, PharmD, MSc, of the University of British Columbia in Vancouver, and colleagues in the Journal of the American…

Case vignette A 46-year-old patient presented to our specialty women’s health clinic with vaginal bleeding. Previously, this patient was treated at our facility for early-stage breast cancer. As part of her treatment, she had a hysterectomy, oophorectomy and was on a long-term adjuvant course of aromatase inhibitors (AIs). The patient was very concerned that the etiology of the bleeding was cancerous. On exam, we determined that a urethral caruncle—a large friable red mass—was…

A medical procedure that aims to allow women to delay the menopause for up to 20 years has been launched by IVF specialists in Britain. Doctors claim the operation could benefit thousands of women who experience serious health problems, such as heart conditions and bone-weakening osteoporosis, that are brought on by the menopause. But the specialists believe the same procedure could also improve the lives of millions more women by delaying the onset of more common symptoms of the menopause,…

(HealthDay News) -- Many older men take testosterone to boost their sex drive, but new research suggests that postmenopausal women who struggle with a sagging libido might want to follow suit. Applied topically, the hormone appears to increase women's sexual function and satisfaction, according to a new review of 36 clinical trials involving nearly 8,500 women. Women naturally produce testosterone as well as estrogen, said lead researcher Susan Davis, a professor of women's health at the…

Tamara A. Sussman, MD, Megan L. Kruse, MD, Holly L. Thacker, MD and Jame Abraham, MD Cleveland Clinic Foundation, Cleveland, OH Patients with breast cancer receiving antiestrogen therapy, specifically aromatase inhibitors, often suffer from vaginal dryness, itching, irritation, dyspareunia, and dysuria, collectively known as genitourinary syndrome of menopause (GSM). GSM can decrease quality of life and is undertreated by oncologists because of fear of cancer recurrence, specifically when…

By Holly L. Thacker, MDRomosozumab-aqqg/Evenity®, a new osteoporosistreatment, was approved by the U.S. Food and Drug Administration in April and will be available in the summer of 2019. This new treatment is a sclerostin inhibitor, which works through a novel (Wnt) pathway and has both anabolic and antiresorptive effects, increasing new bone formation and preventing bone breakdown. The prescribing information indicates that—if warranted—patients be continued on antiresorptive-only…

A baby girl born last month at Cleveland Clinic has made history. She was the first baby in North America delivered by a mother who received a uterus transplant from a deceased donor. The mother, who is in her mid-30s, is part of a groundbreaking research trial involving 10 women with uterine factor infertility. Women who have UFI don’t have a uterus, or had their uterus removed, so they aren’t able to get pregnant. The study is testing whether receiving a uterus transplant from a deceased…

The FDA has cleared a noninvasive device to relieve acute migraine pain. Nerivio Migra is a "first-in-category product," according to Theranica, the company that makes it. It is worn on the upper arm and uses smartphone-controlled electronic pulses to relieve migraine pain. The device is for the acute treatment of migraine with or without aura in adults who don’t have chronic migraine. The FDA approved the device on the basis of results of a randomized, double-blind, placebo-controlled…

The US Food and Drug Administration approved a drug to return sexual desire to some women with low libido, the agency said Friday. The drug, bremelanotide, sold under the brand name Vyleesi by AMAG Pharmaceuticals, is an injection to be taken before sex. It's intended to treat women who are premenopausal and have hypoactive sexual desire disorder, where a lack of interest in sex may cause significant distress in a woman's life. It will be available in September, and the company has not yet…

The US Food and Drug Administration (FDA) has approved Slynd (drospirenone) for use as an oral contraceptive pill. The pill contains drospirenone 4 mg and comes in sets of 24 active pills along with 4 inactive tablets.The New Drug Application (NDA) for drospirenone was submitted to the FDA by Exeltis USA, Inc, which announced the approval of this progestin-only contraceptive tablet."Slynd may be an excellent choice for women who need or want safe and effective oral contraception without the…