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Health & Wellness, 11th Edition
Donnerstag, 20. August 2015
Health & Wellness, 11th Edition
Health & Wellness, 11th Edition
Addyi 'Female Viagra' Gets FDA Approval, But With Warnings
The “female Viagra,” which will be commercially known as Addyi, was approved by the FDA and will be available on the market on October.
By Suzette Gutierrez | Aug 20, 2015 08:01 AM EDT
The side effects of Addyi include hypotension, loss of consciousness, dizziness, nausea, insomnia, sleepiness and fatigue. (Photo : Twitter Photo Section)
Addyi, the “female Viagra,” finally got the green light from the U.S. Food and Drug Administration, but not without warnings about potential side effects. The FDA approved the little pink pill Tuesday, giving a cause for celebration to those who have campaigned for its approval in spite of two previous rejections. Janet Woodcock, FDA’s director for the Center for Drug Evaluation and Research, said the drug gives women with low sexual desire “an approved treatment option.”
“The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction,” Woodcock said in a press release.
Flibanserin, which will be commercially known as Addyi, is the first drug approved as treatment for lack or absence of libido, a condition called generalized hypoactive sexual desire disorder (HSDD). It is targeted specifically for premenopausal women. Before Addyi, no other drug has received FDA approval to treat sexual desire disorders in both men and women, the FDA said.
Unlike Viagra, which addresses erectile dysfunction and is taken before intercourse, Addyi is to be taken every night. That’s because while the little blue pill treats a physical problem, the little pink pill deals with chemicals in the brain and acts more like an antidepressant.
Flibanserin was rejected twice before: once in 2010 while it was still under Boehringer when the FDA dismissed it as having the same effect as a placebo, and another time in 2013 under Sprout Pharmaceuticals when it was rejected on grounds of its adverse side effects outweighing its benefits.
“It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition,” Sprout Pharmaceuticals chief executive officer Cindy Whitehead said in a press release. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”
“This is the biggest breakthrough for women’s sexual health since the pill,” National Consumers League executive director Sally Greenberg said, according to The New York Times.
However, the FDA gives strong warnings about the side effects of Addyi, which can cause hypotension (or extremely low blood pressure) and loss of consciousness. These side effects are increased during alcohol intake because alcohol interferes with the drug’s breakdown in the body. The FDA warns that “health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.”
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Woodcock said. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
The drug’s other side effects include dizziness, nausea, fatigue, sleepiness, insomnia and dry mouth.
Addyi is expected to be available to consumers on Oct. 17.
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Addyi "Female Viagra" Gets FDA Approval, But With Warnings
GUEST COMMENTARY: Men shouldn't decide women's health issues
This attack on women"s health is no different than Gov. … Why should a group of old men be deciding what health care women should be receiving?
GUEST COMMENTARY: Men shouldn"t decide women"s health issues
Mittwoch, 19. August 2015
Crest Pro-Health Sensitive with Enamel Shield Smooth Mint Toothpaste 6 oz., (Pack of 4)
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This pill could (slightly) boost women's sex drive. But it costs $400 and risks fainting and sleepiness
The first pill for low libido in women will go on sale in the U.S. after regulators decided that despite its modest benefit and serious side effects, the drug was worthwhile to address an affliction with no other approved treatments.
The Food and Drug Administration said Tuesday that doctors will have to take a training course to be certified to prescribe Sprout Pharmaceuticals Inc.’s flibanserin, branded Addyi, which will be available as soon as Oct. 17. And patients must sign a form acknowledging risks that include fainting and extreme sleepiness.
Those precautions apply to a drug that has shown in clinical trials to improve sexual desire in patients only slightly. That means closely held Sprout still will have to persuade doctors to prescribe Addyi and insurers to cover the pill, which must be taken daily and will cost about US$350 to US$400 a month before insurance coverage. Sprout expects insurers to put the drug in tier 2 or 3 on their formularies with a US$30 to US$75 copay.
“With any kind of medication you always have to balance the benefit with the risk,” said Holly Thacker, director of the Cleveland Clinic Center for Specialized Women’s Health. “Yes, there are side effects. They’re not life-threatening and they’re not outside the norm of medications in a similar class,” such as neurotransmitters for conditions like depression.
In clinical trials, women who took Addyi recorded a median increase of 0.5 to one more satisfying sexual events each month than those who got a placebo. Women began the trials experiencing two to three satisfying sexual events a month. Some women experienced as many as six to eight more satisfying sexual events each month, Sprout Chief Executive Officer Cindy Whitehead said in a phone interview.
More than 1,300 Canadian women have been involved in tests of flibanserin.
A spokeswoman for Sprout said in June that the company had not yet submitted an application for approval of the drug to Health Canada.
The drug was rejected by the FDA in 2010, and again in 2013, over concerns the less-than-overwhelming benefit — about one extra “sexually satisfying event” per month, compared to placebo — was outweighed by side effects such as dizziness, nausea and sleepiness.
The FDA faced a backlash from some doctors and researchers who claimed the agency was being sexist. Drugs to treat male sexual dysfunction have become ubiquitous since Pfizer Inc.’s Viagra was approved in 1998. Viagra generated US$1.69 billion in sales last year.
Unlike Viagra, which helps men who want to have sex get an erection by increasing blood flow to the penis, Addyi is designed to alter the brain chemistry of women so they find sex more desirable. The drug targets neurotransmitters such as dopamine and norepinephrine that the brain uses to transmit information and can affect mood. Antidepressant drugs use similar mechanisms.
Addyi, also called flibanserin, is approved for women diagnosed with a condition called hypoactive sexual desire disorder, which is low libido that causes stress. Whitehead said doctors will be able to get certified to prescribe the drug by watching an online video.
They have gotten a drug that is barely better than placebo with serious side effects approved
Before the FDA ruling on Addyi, some women’s health experts had argued that the drug’s associated risks of fainting and extreme sleepiness outweighed any benefit. Studies found the risks are exacerbated by alcohol and birth-control medicine.
Sprout backed a lobbying campaign called Even the Score to help pressure regulators to approve Addyi, winning the endorsement of groups such as the National Organization for Women and the American Sexual
“They have gotten a drug that is barely better than placebo with serious side effects approved,” said Adriane Fugh- Berman, the director of PharmedOut, a Georgetown University Medical Center group that calls for thoughtful use of drugs and looks at industry marketing. “I think that we can expect all kind of creative attacks on the FDA to pressure them to approve bad drugs since that tactic appeared to work.”
Addyi’s label will advise women to stop taking the pill if they don’t respond after eight weeks, Whitehead said.
“This is a transformational moment, hopefully across all of women’s health care, certainly in women’s sexual health,” Whitehead said. “Our breaking through, I hope, opens the door for a variety of treatments to come forward.”
In June, FDA advisers recommended in an 18-6 vote that the FDA approve the drug. While advisers said the pill’s effect isn’t as strong as they’d like, they said they voted in favor to get the first female sexual desire drug on the market and boost awareness to get better treatments on pharmacy shelves in the future.
About 2 million women are currently seeking treatment for the disorder and more are expected to come forward once Addyi is on the market, said Carl Spana, CEO of Palatin Technologies Inc., which is developing its own female sex-drive treatment.
The company is in the final stages of testing its drug bremelanotide for use as needed, like Viagra, while Addyi is taken every night before bed. Palatin estimates the market for low female sexual desire treatments could total US$1.3 billion a year, based on the 2 million women known to be affected.
Palatin shares jumped 28 percent to US$1.20 in late trading after Sprout’s approval was announced.
Palatin could bring bremelanotide to market in early 2018, Spana said. The company has had talks with larger drugmakers, which he declined to name, that would likely license bremelanotide for sale.
With files from The Canadian Press and Postmedia News
This pill could (slightly) boost women"s sex drive. But it costs $400 and risks fainting and sleepiness
Dienstag, 18. August 2015
Health Assessment in Nursing
Innovative, systematic, and easy to understand, Health Assessment in Nursing has already helped thousands of RN-level students develop the comprehensive knowledge base and expert nursing assessment skills necessary for accurate collection of client data.
In this revised Fifth Edition, the authors provide in-depth, accurate information, a compelling Continuing Case Study that covers every step in the assessment process, a focus on diversity and health assessment through the lifespan, a striking photo and illustration program that includes photos of practicing registered nurses and nurse practitioners performing assessments, dynamic online video clips and animations, and much more.
Using this book you’ll have everything at your fingertips to master the knowledge and assessment skills you’ll need in your nursing career.
- Master the “how-to’s” of conducting a nursing assessment through the real world Continuing Case Study in every chapter that introduces a client with a health concern, guides you through investigation of symptoms using the COLDSPA mnemonic, and demonstrates a physical assessment, proper documentation techniques, diagnostic reasoning, and appropriate nursing conclusions.
- Access an easy-to-understand tool for data collection with the Collecting Subjective Data: Nursing Health History table, which presents Information in two columns: Questions that you will ask the client and Rationales explaining why the questions are important.
- Master every aspect of the physical examination through the Collecting Objective Data: Physical Examination table, which illustrates physical examination procedures in a step-by-step fashion across three columns: Assessment Procedure (which explains and illustrates exactly how to perform specific aspects of the examination), Normal Findings, and Abnormal Findings.
- Identify important distinctions
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Health Assessment in Nursing
Health-related events, classes, more around Asheville
Share your events at CITIZEN-TIMES.com/events at least two weeks in advance of publication.
Health events
LONG TERM CARE PLANNING: Aug. 19, 2-4 p.m., Pardee Signature Care Center at Blue Ridge Mall, Four Seasons Boulevard, Hendersonville. Focuses on alternatives in long-term care planning. Explore medical care options, financial considerations, insurance and other issues. Free but visit www.pardeesignaturecare.org or call 828-692-4600 to register.
DIABETES Support Group Meet & Greet with Pardee Hospital’s new endocrinologist Jonathan Rappaport: Aug. 19, 10-11:30 a.m., Pardee Signature Care Center in the Blue Ridge Mall, Four Seasons Boulevard, Hendersonville. Rappaport will present program on diabetes care and management, attendees may ask questions. Free. www.pardeehospital.org.
QIGONG for Health & Heart: 10 a.m. Wednesdays, Unity Center, 2041 Old Fanning Bridge Road, Mills River. Slow, meditative movements to improve balance, restore health and connect you with your heart energy for harmony and relaxation. Can be done standing or sitting. $5 suggested donation. 201-452-8244 or www.starhorsejourneys.com.
ALZHEIMER’S-Effective Communication Strategies: Aug. 20, 1-2:30 p.m., Haywood County Public Library, 678 S. Haywood St., Waynesville. Explores how communication takes place when someone has Alzheimer’s disease. For caregivers, learning to decode messages through attitude, tone of voice, facial expressions and body language can help both parties to connect and communicate in meaningful ways. RSVP to Kathy Olsen at 828-452-5169.
GYNECOLOGICAL HEALTH & WELLNESS: Aug. 20, 6-7 p.m., Pardee Signature Care Center at Blue Ridge Mall, Four Seasons Boulevard, Hendersonville. Dr. Shannon Huff, of Pardee OB/GYN Associates, discusses risk factors for gynecological cancers, offer recommendations on minimizing risks, early detection and the necessity of pap smears after a hysterectomy. Symptoms of gynecological cancers are often silent. Free but visit www.pardeesignaturecare.org or call 828-692-4600 to register.
TAI CHI FOR ARTHRITIS: 12-week class begins Aug. 26. 11 a.m. and 2:30 p.m. Wednesdays (beginner) at Homewood, 19 Zillicoa St., Asheville, or 4:30 and 7:30 p.m. at First Baptist Church of Asheville, 5 Oak St., downtown. Level 2 classes at noon and advanced level 2 at 4 p.m. at Homewood and 7:30 p.m. at First Baptist. $140 with discounts to $126 with doctor prescription or for members of First Baptist Church, Asheville. Can be done sitting or standing. Not just for arthritis. www.wnctaichiarthritis.com or 828-253-8649 or 828-230-9208.
“MEDICARE CHOICES MADE EASY” CLASS: Aug. 27, 5-7 p.m., Twisted Laurel, 10-A S. Main St., Weaverville. Hosted by The Council on Aging and Merrill Lynch. . The classes help individuals 60 and older make informed decisions on the Medicare benefits that are right for them. Free but register at www.coabc.org. For more information about the classes, contact John Wingerter at JohnW@coabc.org or 828-277-8288 ext. 310.
MOVIE “FED UP”: Aug. 27, 6 p.m., Carolina Cinemas, 1640 Hendersonville Road, Asheville. Join Blue Sky MD for a free screening. The documentary, from Katie Couric and “An Inconvenient Truth” producer Laurie David, takes a close look at the food industry and the foods Americans consume every day. Healthy refreshments provided. Email kinsay.sand@blueskymd.com to RSVP. 828-274-9500.
MELANOMA Lunch and Learn workshop: Aug. 28, noon-1 p.m., Pardee Hospital, 800 N. Justice St., Hendersonville. This workshop will discuss melanoma including the different types of moles, the role of sunscreen, and why tanning beds should be avoided. Free admission and light lunch. Call 828-696-1341 by 4:30 p.m. Aug. 25 to register.
RESTORING DIGESTIVE HEALTH: Nourishing Herbs, Foods & Ferments for Vitality: Sept. 11, 10 a.m.-4 p.m., Warren Wilson College, Warren Wilson Road, Swannanoa. Workshop with herbalist, foodie, naturalist, and traditional food ways maven, Lindsay Wilson. Explore ways to heal the gut and take charge of your digestion. $75. http://organicgrowersschool.org/events/harvest-conference/pre-conference-workshops/.
NEED HEALTH INSURANCE?: Pisgah Legal Services, 62 Charlotte St., Asheville, offers free year-round appointments with Health Care Navigators so you can explore your options for getting affordable health insurance. Call 828-210-3437 to make an appointment. Open enrollment begins Nov. 1 and lasts until Jan. 31, 2016. However, special enrollments are available for qualifying life events. Did you also know that 9 out of 10 people in North Carolina qualified for financial help in paying their monthly premiums?
Health screenings
BLOOD PROFILE TESTING: 8:30-10 a.m. every Wednesday, Opportunity House, 1411 Asheville Highway, Hendersonville. No appointment needed. Comprehensive metabolic, complete blood count, lipid panel, thyroid, PSA and urinalysis to name a few. For a complete list of tests and pricing, visit www.opportunityhouse.org and click on newsletter. Results are usually back in a few days. Cash, checks and credit cards accepted. 828-692-0575.
SCREENING BREAST THERMOGRAMS: Aug. 25, Asheville Integrative Medicine, 832 Hendersonville Road. Thermography is a noninvasive test that does not cause radiation exposure or compression of the breasts. Initial thermogram is $149. Process takes about 15 minutes. Results will be interpreted by an M.D. and originals mailed to patient within 10 days. A copy of the interpretation can go to the physician of choice. Call 828-252-5592 to make an appointment.
Meditation
ASHEVILLE MOVEMENT COLLECTIVE DANCES: 8:30 and 10:30 a.m. Sundays, Masonic Temple, 80 Broadway St., downtown. Non-instructional, free-form dances to inspire authenticity and healthy community. No prior experience required. Two dances, your second dance is free. $7-$15. http://ashevillemovementcollective.org. ALSO 7 p.m. Fridays at Asheville Academy of Ballet at 4 Weaverville Road.
CHANGE YOUR WORLD: New Approaches to Life, Love & Happiness: 7 p.m. Sundays to Oct. 18 (no class on Aug. 30), Anjali Hot Yatra Yoga, 780 Hendersonville Road, Asheville. By learning to be more peaceful, loving and positive, we can learn to be happy whether or not our life changes externally. With Buddhist teacher Sharon Lovich. Drop-in classes. $10, $5 students/seniors. 803-200-2115 or www.MeditationInAsheville.org.
TONING THE CHAKRAS INSIDE SALT CAVE: Aug. 30, 6-7 p.m., Asheville Therapeutic Salt Cave, 12 Eagle St. Vocal toning is a form of sound meditation. It usually consists of singing extended syllables, especially vowels. These sounds are believed to have their own energetic properties. We will be group toning the bijas of the chakras, simple Sanskrit syllables, originating in Hinduism, believed to balance the energy centers of the subtle body. Combining sound and stones can produce deep meditative experiences. $36. 828-236-5999 or www.ashevillesaltcave.com.
Self-help groups
GAMBLING: 12 Step Gamblers Anonymous Meeting: 6:45-7:45 p.m. Thursdays, lower level conference room at Basilica of Saint Lawrence, 97 Haywood St., Asheville. A closed meeting reserved for people that have or think they may have a gambling problem. Anonymity is first and foremost. We welcome you with open arms. Park behind the church and ring the bell at the back door. Contact Casey at 828-318-4800 or kc1st@mac.com. Visit www.gamblersanonymous.org.
Support groups
ADDICTION COUNSELING: Narconon can help you take steps to overcome addiction in your family. Call 800-431-1754 for free screenings or referrals.
BETTER TOGETHER: Life Limiting Illness Support Group: 6:30 p.m. Tuesdays, Secrets of A Duchess, 1439 Merrimon Ave., Asheville. Weekly support group for adults managing the challenges of cancer, diabetes, heart disease, autoimmune diseases. Free but call 386-801-2606 to reserve your spot. Visit www.WildPrecious.Life.
GRIEF CLASSES: CarePartners, 68 Sweeten Creek Road, Asheville, offers grief classes at its bereavement center. 828-251-0126.
BEREAVEMENT SUPPORT-Marshall: Aug. 18, 2-3 p.m., Center Community Center, 1300 Grapevine Road, Marshall. For anyone in the Madison County area who has lost a loved one. Every third Tuesday. www.hotspringshealth-nc.org.
DIABETES: Aug. 19, 3:30-5 p.m., Mission Health Diabetes and Health Education Center, 1 Hospital Drive, third level, room 3308, Asheville. Every third Wednesday. Contact Laura Tolle at 828-213-4788 or Laura.Tolle@msj.org.
IN GOOD COMPANY Breast Cancer Support: Aug. 20, 5:30-6:30 p.m., SECU Cancer Center, 21 Hospital Drive, room R-120, Asheville. Every third Thursday for breast cancer survivors. Husbands, children and friends encouraged to participate. For more information, call Denise Steuber at 828-213-2508 or Janet Magruder at 828-213-2507.
BRAIN INJURY SUPPORT FOR TEENS & YOUNG ADULTS: Aug. 25, 6-8 p.m., Foster Seventh-Day Adventist Church, 375 Hendersonville Road, Asheville. Every fourth Tuesday. Contact Karen Harrington at 828-277-4868.
BEREAVEMENT-Mars Hill: Aug. 27, 2-3 p.m., Mars Hill Retirement Center, 170 S. Main St., Mars Hill. Every fourth Thursday. www.hotspringshealth-nc.org.
INCONTINENCE: Sept. 10, 1 p.m., West Asheville. For those suffering from or affected by any level or form of incontinence. Every second Thursday. For more information e-mail WNCIncontSG@bellsouth.net.
Health-related events, classes, more around Asheville