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Many Women Are Sharing Breast Milk, and That Has Health Experts Worried

FRIDAY, Oct. 25, 2019 — “Informal” sharing of breast milk may be more common than thought, with too many parents mistakenly thinking it’s risk-free, new research suggests.

In a pair of studies, researchers delved into the issue of donor breast milk, and how parents are choosing to get it. In one, a survey of 655 parents who used donor milk found that only about 36% got it from official “milk banks” that screen and pasteurize donations.

Most said they’d turned to “informal” sharing, where parents get breast milk either from a nursing mom they know or via the internet. It’s a practice discouraged by the American Academy of Pediatrics (AAP) and U.S. Food and Drug Administration due to safety concerns.

There is a risk of dilution, or contamination with viruses or bacteria, particularly with donor milk obtained online, explained Dr. Lori Feldman-Winter, who chairs the AAP’s Section on Breastfeeding.

Certain viruses, such as HIV, can also be transmitted through breast milk.

“If you get breast milk from someone you know, it’s probably a low-risk situation,” said Feldman-Winter.

However, she added, that doesn’t mean there’s no risk.

Study author Dr. Ruth Milanaik, of Cohen Children’s Medical Center/Northwell Health in New York, made the same point. Even when breast milk is given for free, with the best of intentions, she said there could be accidental contamination or temperature instability that causes the milk to spoil.

“The only recommended option for obtaining donor breast milk is through a milk bank,” said Milanaik.

That is easier said than done, however.

Right now, there are 28 nonprofit milk banks across the United States that are part of the Human Milk Banking Association of North America. And most of that milk, Feldman-Winter explained, goes to hospitals for preemies whose mothers cannot yet express their own breast milk.

That means little left over for moms of full-term infants who cannot breastfeed, or for adoptive or male gay parents. And even when it is available, there is a steep cost — around $ 4 an ounce, Milanaik said.

With informal sharing, parents may get breast milk for free — either from a friend or by finding a local donor with the help of social networking. There are also websites that allow women to sell their breast milk — it’s not a cheap option, but the prices are typically lower than those of a milk bank, Milanaik noted.

Breast milk is considered the best nutrition for infants. However, it’s not clear whether, for most babies, donor breast milk is a healthier choice than formula.

There’s proof of the benefits to preemies in the hospital, Feldman-Winter said. But when it comes to healthy, full-term infants, “the science just isn’t there yet,” she said.

So if breastfeeding or banked milk are not options, the AAP recommends formula-feeding.

The new findings will be presented by Milanaik and co-author and Cohen researcher Nikita Sood on Saturday at the AAP’s annual meeting in New Orleans, and are based on two related studies. Such research is considered preliminary until published in a peer-reviewed journal.

In the first study, a survey found that of those who chose informal sharing, 56% said they had no safety concerns, and 78% did not ask for medical information from donors because they “trusted them.” More than half said they opted for informal sharing over milk banks due to costs.

In the other study, the researchers looked at 122 parenting-blog posts on donor breast milk. Most, they found, focused on informal sharing rather than milk banks, and most “lacked important discussion of safety concerns.”

It’s not clear how many parents are choosing informal milk sharing. But the new findings suggest it may be more common than pediatricians realize, Feldman-Winter said.

“Certainly one of the take-home messages here is that doctors should talk about this,” she said. “We’re missing an opportunity, as pediatricians, to open up a dialogue and help clarify misperceptions.”

As for nursing moms who have extra milk they want to donate, Milanaik urged them to give to a milk bank.

More information

The Human Milk Banking Association of North America has more on breast milk donation.

© 2019 HealthDay. All rights reserved.

Posted: October 2019

Drugs.com – Daily MedNews

Can Testosterone Make Women Better Runners?

WEDNESDAY, Oct. 16, 2019 — A little bit of testosterone cream might help women run faster longer, a new study suggests.

Some female athletes have naturally high testosterone levels that are similar to men, and there is controversy over whether it’s fair to allow them to compete against female athletes with normal testosterone levels.

There’s a lack of clear evidence on how testosterone levels affect women’s athletic performance. To learn more, Swedish researchers gave 48 physically active, healthy women between the ages of 18 and 35 either 10 milligrams (mg) of testosterone cream or 10 mg of a placebo cream every day for 10 weeks.

The researchers, led by Angelica Linden Hirschberg from the Karolinska Institute in Stockholm, assessed how testosterone levels affected aerobic performance by measuring how long the women could run on a treadmill before becoming exhausted.

Average circulating levels of testosterone rose from 0.9 nanomoles/liter of blood (nmol/l) to 4.3 nmol/l among the women given the testosterone cream. There was no increase among the women who received the placebo.

Compared to the women in the placebo group, running time to exhaustion increased by 21.2 seconds (8.5%) among the women in the testosterone cream group.

The women in the testosterone cream group also had much larger gains in lean muscle mass than those in the placebo group.

On average, testosterone levels among women who received the hormone cream rose to levels that were below the average range in men. Yet, that level significantly increased the length of time they could run before reaching exhaustion, according to the study published online Oct. 15 in the British Journal of Sports Medicine.

Female athletes with naturally high testosterone levels must lower their levels to below 5 nmol/l of blood to be eligible to compete at international level in middle distance races, the International Association of Athletics Federations says.

The policy has been widely criticized and challenged in court.

“Our results are therefore of great importance for the ongoing discussion of whether it is fair to allow athletes with naturally high testosterone to compete in the female category without reducing their hormonal concentration to the female range,” Hirschberg and her colleagues concluded in a journal news release.

More information

The Hormone Health Network has more on testosterone.

© 2019 HealthDay. All rights reserved.

Posted: October 2019

Drugs.com – Daily MedNews

AHA News: Women and Men Tolerate Heart Transplants Equally Well, But Men May Get Better Hearts

FRIDAY, Oct. 11, 2019 (American Heart Association News) — Women are just as likely as men to survive after a heart transplant despite often getting poorer-quality donor hearts, new research shows.

The findings, published this week in the American Heart Association journal Circulation: Heart Failure, sought to shed new light on what role, if any, gender plays in surviving a heart transplant. Past research on post-transplant survival rates and gender have told conflicting stories.

For the new study, researchers looked at data from 34,198 international heart transplant recipients from 2004 to 2014 and, after adjusting for recipient and donor factors, they found “no significant survival difference” between men and women.

“That’s a pretty novel finding,” said study author Dr. Yasbanoo Moayedi, a postdoctoral medical fellow at Stanford University in California. “We already know that women are hugely under-represented as recipients of heart transplants, but the striking thing about the new findings is there’s no difference in survival when matched to their male counterparts.”

The study also found women who get heart transplants appear to have lower-risk features than male recipients, with fewer instances of diabetes, high blood pressure, smoking, peripheral vascular disease and past cardiovascular surgery. Yet, women appear to receive higher-risk hearts than men.

“We need to better understand the matching of risk with recipient,” Moayedi said. “We hypothesize that women tend to deteriorate more acutely, and they’re sicker, so they take any heart that’s available.”

She said the findings suggest women with advanced heart failure need to be referred a bit earlier for transplant.

“One takeaway of the study is that maybe we’re missing the optimal window [for women],” she said. “Many factors may determine access to transplant, but gender should not be one of the them.”

The study was limited by its observational nature and its lack of data on waitlist mortalities, donor race and information about how sick patients where when they received a transplant.

Dr. Monica Colvin, a heart failure-transplant cardiologist who was not involved in the research, called it “a contemporary analysis” because it included newer devices and current medical therapy.

“There have been anecdotes of women having worse survival than men after heart transplant and studies have been conflicting,” said Colvin, director of the Heart Failure Network Strategy at the University of Michigan. “This study should dispel that myth and inform doctors that there really is no difference. We should not delay or defer referral for this lifesaving treatment based on concern for differential survival in women.”

An estimated 6.2 million U.S. adults have heart failure. In 2018, there were 3,408 heart transplants, according to the federal Organ Procurement and Transplantation Network.

Moayedi would like to see future studies explore why more women don’t undergo heart transplants and how a doctor’s gender might play into that decision.

“Is it that women don’t see themselves worthy enough for a heart transplant? As a patient, should I be more of an advocate for my symptoms? These things need to be looked at more systematically to learn how to best help the patient,” Moayedi said.

Colvin advises women with advanced heart failure to be seen at an advanced heart failure center “and seek out as much information as they can. It’s important to know what all your options are.”

© 2019 HealthDay. All rights reserved.

Posted: October 2019

Drugs.com – Daily MedNews

Only a Third of Pregnant Women Getting Vaccinations They Need

TUESDAY, Oct. 8, 2019 — About two-thirds of pregnant women in the United States don’t get vaccinated against both flu and whooping cough, putting them and their newborns at risk, a new report from the U.S. Centers for Disease Control and Prevention says.

“Influenza and pertussis (or whooping cough) are serious infections that can be deadly for babies, especially those who are too young to be vaccinated directly,” Dr. Anne Schuchat, principal deputy director of the CDC, said in a news briefing on Tuesday.

But when women receive these vaccines during pregnancy, they pass along antibodies to the fetus that then provide protection during the time newborns are too young to be vaccinated.

The vaccines also benefit expectant mothers, Schuchat stressed.

“Women who are pregnant are more than twice as likely to be hospitalized if they develop influenza, compared with similar-aged women during influenza season,” she said.

But as the new CDC report found, only a minority of pregnant American women are getting the shots they need.

The agency surveyed nearly 2,100 women aged 18 to 49 who were pregnant between August 2018 and April 2019. Of those, 54% said they got a flu shot before or during pregnancy, and 55% were vaccinated for whooping cough while pregnant.

That could mean more pregnant women becoming very ill, the report also found.

Looking at data on all 15- to 44-year-old women who were hospitalized due to flu since 2010, between 24% and 34% were pregnant, the CDC study found, even though only 9% of U.S. women in this age group are pregnant at any given time each year.

“Women have enough issues to address when they’re pregnant without going through a difficult hospitalization if they come down with influenza,” Schuchat said.

In total, only about 35% of women received both vaccinations during pregnancy, the CDC said.

Dr. Laura Riley, an obstetrician and gynecologist-in-chief at NewYork-Presbyterian and Weill Cornell Medicine, in New York City, said, “The numbers are much lower than they should be and it is disappointing given the benefits for moms and babies associated with these vaccines.” She said the numbers may be low because they came from an online survey that depended on patient recall.

But, Riley added, it’s important for pregnant women to get protection from the flu. “If they get the flu, [they] are at greater risk for having severe complications like ICU admission, maternal death, prematurity, preterm labor,” she explained.

The survey found that women whose health care providers offered or referred them for shots had the highest vaccination rates. Black women had lower rates than women in other racial/ethnic groups, and were less likely to report being offered or referred for vaccination, the findings showed.

The CDC recommends all pregnant women get a flu shot at any stage of pregnancy and the whooping cough vaccine (Tdap) early in the third trimester as part of routine prenatal care.

A flu shot reduces a pregnant woman’s risk of being hospitalized due to flu by an average of 40%, a recent study found.

The flu is also dangerous for babies, especially those younger than 6 months. They are too young to get their own flu shot and have the highest incidence of flu-related hospitalization and greatest risk of flu-related death among children.

Flu vaccination in pregnant women reduces the risk of flu-related hospitalization for infants under 6 months of age by an average of 72%, according to the CDC.

And whooping cough can be deadly, especially before babies start getting the vaccine at 2 months of age. Two-thirds of babies under 2-months-old who get the disease require hospital care. Seven of 10 whooping cough deaths (69%) occur in that age group.

Tdap vaccination during the third trimester of pregnancy prevents more than 78% of whooping cough in babies under 2-months-old.

Schuchat suggested that many women may have the mistaken belief they are already protected.

“Many women thought because they previously received it (Tdap) that it was not needed again during the current pregnancy,” she said during the news briefing. “But we’ve actually been recommending women get Tdap shots during each pregnancy since 2012.”

And for any woman wary of getting vaccinated, Schuchat said that “it’s been proven repeatedly that these vaccinations are safe for pregnant women and their developing babies.”

Dr. Amanda Cohn, chief medical officer at the CDC’s National Center for Immunization and Respiratory Diseases, called on obstetricians and midwives to discuss the importance of maternal vaccination with their pregnant patients.

CDC Director Dr. Robert Redfield underscored the point.

“All expectant mothers should be up-to-date with recommended vaccinations as part of their routine prenatal care,” he said in a CDC news release. “CDC strongly recommends that health care providers speak with moms-to-be about the benefits of safe Tdap and flu vaccination for their health and the well-being of their babies.”

The new research was published Oct. 8 in the CDC’s Vital Signs report.

More information

The U.S. Centers for Disease Control and Prevention has more on pregnancy and vaccines.

© 2019 HealthDay. All rights reserved.

Posted: October 2019

Drugs.com – Daily MedNews

HRT Could Benefit Younger Women After Hysterectomy

By Serena Gordon
HealthDay Reporter

MONDAY, Sept. 9, 2019 (HealthDay News) — Estrogen therapy may help younger women live longer after having their uterus and ovaries surgically removed, new research reports.

The study found that when women under 60 received hormone replacement therapy (HRT) after surgery, their risk of dying during the 18-year follow-up period decreased by almost one-third compared to women taking a placebo.

“In a young woman, it’s generally better to conserve the ovaries, because early removal of the ovaries induces early surgical menopause and increases the risk of cardiovascular disease, fractures and osteoporosis. But if the ovaries are removed, and a woman is under 60, estrogen therapy gives them a more favorable risk profile,” said study lead author Dr. JoAnn Manson. She’s chief of the division of preventive medicine at Brigham and Women’s Hospital in Boston.

About 425,000 women have a hysterectomy (uterus removal) every year in the United States. Between a third and a half also have their ovaries removed. This is done to reduce their risk of ovarian cancer, according to the researchers.

Removing the ovaries is also known to reduce breast cancer risk. But when they are removed in younger women (around 45 to 50), the procedure is linked to a higher risk of heart disease and death from any cause, the researchers noted.

“Women who have had their ovaries removed have an abrupt decline in their estrogen levels, more so than women with intact ovaries,” Manson explained.

Researchers had a hunch that replacing that lost estrogen might reduce the risk of heart disease and early death.

To see if that was the case, they recruited about 10,000 women who had a hysterectomy. They were between 50 and 79 years old. Just over 4,000 also had both ovaries removed.

The women were randomly assigned to receive either estrogen or a placebo for about seven years. Their health was followed for 18 years.

Women in their 50s who had their ovaries removed had a 32% lower risk of dying during the study if they took estrogen, the findings showed. Older women who had their ovaries removed and took estrogen didn’t have that same benefit.

Continued

Women who still had their ovaries didn’t seem to have any benefits or harms related to taking estrogen, the study found.

Dr. Meera Garcia, division chief of obstetrics and gynecology at New York-Presbyterian Hudson Valley Hospital in Cortlandt Manor, N.Y., reviewed the study and welcomed the findings. “This study provides a great support and evidence to what’s going on in clinical practice,” she said.

“Everything has benefits and side effects, and with hormones, we’re coming more to the middle now,” Garcia added. “There’s a right time and a right place for medication, and when we’re continuing what the body has been doing [by replacing estrogen in younger women] — it seems to provide benefits.”

Both Manson and Garcia said there’s no absolute cut-off age for hormone therapy.

“The duration of estrogen therapy is an individual decision. Is a woman continuing to have hot flashes? What is her risk for breast cancer? What about cardiovascular disease risk? Or a risk of osteoporosis? All of these factors come into play when making the decision,” Manson explained.

Garcia said when women decide it’s time to come off of hormone therapy, it’s helpful to slowly lower the dosage over time.

The findings were published Sept. 9 in the Annals of Internal Medicine.

WebMD News from HealthDay

Sources

SOURCES: JoAnn Manson, M.D., chief, division of preventive medicine, Brigham and Women’s Hospital, and professor of medicine, Harvard Medical School, Boston; Meera Garcia, M.D., division chief, obstetrics and gynecology, New York-Presbyterian Hudson Valley Hospital, Cortlandt Manor, N.Y.;Annals of Internal Medicine, Sept. 9, 2019

Copyright © 2013-2018 HealthDay. All rights reserved.

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Who Multitasks Better: Men or Women? The Answer May Surprise You

WEDNESDAY, Aug. 14, 2019 — Multitasking is equally taxing for women and men, according to a study that challenges the popular notion that women are better at it.

For the study, 48 women and 48 men were asked to do letter or number identification tasks. In some tests, they had to pay attention to two tasks at once (concurrent multitasking). In others, they had to switch attention from one task to another (sequential multitasking).

Researchers measured participants’ reaction times and accuracy on both types of multitasking and while doing single tasks.

The results showed that compared with their performance on single tasks, women and men had similar, significant declines in speed and accuracy when multitasking.

The study was published Aug. 14 in the journal PLoS One.

The findings support growing evidence contradicting the common belief that women are better at multitasking than men, according to the authors.

“The present findings strongly suggest that there are no substantial gender differences in multitasking performance,” study author Patricia Hirsch said in a journal news release. Hirsch is a scientist at RWTH Aachen University in Aachen, Germany.

She and her team noted that different findings on gender and multitasking may owe to the specific tasks assessed. They said no single study can assess all the mental demands of multitasking.

However, at least for the mental demands of multitasking assessed in this study — working memory updating, engagement and disengagement of task sets, and inhibition — men and women have similar results, researchers said.

More information

The American Psychological Association has more on multitasking.

© 2019 HealthDay. All rights reserved.

Posted: August 2019

Drugs.com – Daily MedNews

Diabetes Raises Heart Failure Risk More in Women Than Men

FRIDAY, July 19, 2019 — Diabetes brings with it a variety of long-term complications, but at least one of those — heart failure — is a bigger threat to women than men, new research suggests.

The risk difference was even more pronounced for women with type 1 diabetes.

“Our global review of 12 million people shows that having diabetes increases the risk of heart failure in both women and men. However, this increase is greater for women than men,” said study author Toshiaki Ohkuma. He’s an honorary senior fellow at The George Institute for Global Health at the University of New South Wales in Sydney, Australia.

One of Ohkuma’s co-authors, Sanne Peters, quantified these differences. “Type 1 diabetes was associated with a 5.15 times higher risk of heart failure in women and a 3.47 times higher risk in men — meaning a 47% higher risk of heart failure for women compared to men,” she explained.

Peters noted that women with type 2 diabetes — the more common form of diabetes — had nearly twice the risk of having heart failure. Men with type 2 diabetes had a 1.74 times higher risk. That means the risk of heart failure is 9% higher for women with type 2 diabetes compared to men.

Peters is a research fellow in epidemiology at The George Institute for Global Health at the University of Oxford in the United Kingdom.

Heart failure is different than a heart attack. During a heart attack, the heart is starved of blood and oxygen, leaving part of the heart damaged. In heart failure, the heart isn’t able to pump blood efficiently, according to the American Heart Association. This means the body may not be getting enough blood and oxygen.

Although the new research wasn’t designed to tease out a definitive cause of the increased risk, the researchers suspect that under-treatment of diabetes in women may play a role. The study authors also noted that other heart disease risk factors, such as high blood pressure, seem to be more common in women than in men.

Ohkuma also pointed out that women may have had prolonged exposure to high blood sugar levels, which can affect the heart’s ability to function. It can take up to two years longer for women to be diagnosed with diabetes than men.

Dr. John Osborne, an American Heart Association spokesperson and director of cardiology at State of the Heart Cardiology in Southlake, Texas, said, “There’s still a problem with diagnosing women. In this study, they spent longer in the ‘prediabetes’ stage than men.”

That delay, he said, may be a factor in the differences in heart failure risk.

“Diabetes is bad for everyone, but in women, it’s really bad,” Osborne said.

The new research included information from 14 studies. Those studies included 47 distinct groups comprised of more than 12 million people. (About 3.2 million had type 1 diabetes).

So, what can someone with diabetes, especially a woman with type 1 diabetes, do to lessen the risk of heart failure?

Peters said a healthy lifestyle and controlling high blood pressure, diabetes and coronary heart disease are all important for preventing heart failure. She added that preventing diabetes in the first place is also helpful.

Osborne said eating right, getting regular exercise and not smoking are all important in preventing heart failure. If you have diabetes, newer medications — known as SGLT2 inhibitors — have been shown to reduce the risk of heart failure, he said.

If you have a family history of heart failure, or you have high blood pressure, abnormal cholesterol and excess weight, it’s important to talk with your doctor about your heart failure and diabetes risk.

The study was published July 18 in Diabetologia.

More information

Learn more about heart-healthy habits from the U.S. National Heart, Lung, and Blood Institute.

© 2019 HealthDay. All rights reserved.

Posted: July 2019

Drugs.com – Daily MedNews

FDA Approves Second Drug For Women With Low Libido

By EJ Mundell

HealthDay Reporter

FRIDAY, June 21, 2019 (HealthDay News) — The U.S. Food and Drug Administration on Friday gave its approval to Vyleesi, the second medication so far approved to help women with low sexual desire.

In a news release, the FDA said that Vyleesi (bremelanotide) is a drug that would be administered by injection prior to having sex.

It’s been specifically approved for premenopausal women with a condition known as acquired, generalized hypoactive sexual desire disorder (HSDD).

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” said Dr. Hylton Joffe, who directs the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.

“Today’s approval provides women with another treatment option for this condition,” Hylton said in the news release.

According to the agency, HSDD is not caused by any medical or psychiatric condition, relationship issues or drug side effects.

Instead, women with HSDD have “previously experienced no problems with sexual desire,” the FDA said. “Generalized HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation or partner.”

The exact way in which Vyleesi helps stimulate sexual desire remains unclear, but it works on melanocortin receptors on cells, the FDA said.

The drug is injected under the skin of the abdomen or thigh at least 45 minutes prior to a sexual encounter, although the best timeframe for dosing could vary from user to user.

Side effects can occur, the FDA added, and include nausea and vomiting, flushing, injection site reactions and headache. Nausea was especially common, affecting 40% of users in the clinical study that led to approval.

That study involved 1,247 premenopausal women with HSDD who received Vyleesi or a placebo in one of two 24-week trials.

“In these trials, about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared to about 17% of those who took placebo,” the FDA noted.

Continued

Still, the overall benefit was not large. “There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events. Vyleesi does not enhance sexual performance,” the FDA said.

And there was one other caveat: Vyleesi can hike blood pressure, so people with heart disease or high blood pressure should not take it, the FDA said.

Vyleesi should also not be taken by anyone who is also taking the drug naltrexone, used to combat opioid dependency, because Vyleesi reduces naltrexone’s effectiveness.

Vyleesi is not the first drug approved to enhance flagging libido in women. In 2015 the FDA approved Addyi (flibanserin) for the purpose, but the drug did not become widely used because it cannot be taken with alcohol and only certain certified health care providers are allowed to prescribe it.

According to CNN, Vyleesi’s maker, AMAG Pharmaceuticals, said the new drug will not be available until September, and pricing and reimbursement have yet to be determined.

One expert in female sexual health said it remains to be seen how widely Vyleesi will be used.

Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it’s more difficult to treat,” Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University’s Center for Women’s Health, told CNN. She had no role in Vyleesi’s development.

Cirini suspects Vyleesi probably will not be the first option women with HSDD turn to, but it might prove a useful adjunct to standard psychotherapy and Addyi.

Vyleesi, like Addyi, probably won’t be overprescribed, Cirino added. When Addyi was introduced, there were concerns “that doctors would just be prescribing this medication to anybody that came in saying that they were having an issue with their libido,” she said. “And I think we have to give physicians more credit than that. In fact, that didn’t happen at all.”

Still, Vyleesi could help some women, Cirino said.

“There’s so many chemical factors that influence our libido,” she told CNN. “So you can’t discount using a chemical treatment as part of the broad approach to low libido.”

WebMD News from HealthDay

Sources

SOURCES: U.S. Food and Drug Administration, news release, June 21, 2019;CNN

Copyright © 2013-2018 HealthDay. All rights reserved.

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FDA Approves Second Drug, Vyleesi, to Help Women With Low Libido

FRIDAY, June 21, 2019 — The U.S. Food and Drug Administration on Friday gave its approval to Vyleesi, the second medication so far approved to help women with low sexual desire.

In a news release, the FDA said that Vyleesi (bremelanotide) is a drug that would be administered by injection prior to having sex.

It’s been specifically approved for premenopausal women with a condition known as acquired, generalized hypoactive sexual desire disorder (HSDD).

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” said Dr. Hylton Joffe, who directs the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.

“Today’s approval provides women with another treatment option for this condition,” Hylton said in the news release.

According to the agency, HSDD is not caused by any medical or psychiatric condition, relationship issues or drug side effects.

Instead, women with HSDD have “previously experienced no problems with sexual desire,” the FDA said. “Generalized HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation or partner.”

The exact way in which Vyleesi helps stimulate sexual desire remains unclear, but it works on melanocortin receptors on cells, the FDA said.

The drug is injected under the skin of the abdomen or thigh at least 45 minutes prior to a sexual encounter, although the best timeframe for dosing could vary from user to user.

Side effects can occur, the FDA added, and include nausea and vomiting, flushing, injection site reactions and headache. Nausea was especially common, affecting 40% of users in the clinical study that led to approval.

That study involved 1,247 premenopausal women with HSDD who received Vyleesi or a placebo in one of two 24-week trials.

“In these trials, about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared to about 17% of those who took placebo,” the FDA noted.

Still, the overall benefit was not large. “There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events. Vyleesi does not enhance sexual performance,” the FDA said.

And there was one other caveat: Vyleesi can hike blood pressure, so people with heart disease or high blood pressure should not take it, the FDA said.

Vyleesi should also not be taken by anyone who is also taking the drug naltrexone, used to combat opioid dependency, because Vyleesi reduces naltrexone’s effectiveness.

Vyleesi is not the first drug approved to enhance flagging libido in women. In 2015 the FDA approved Addyi (flibanserin) for the purpose, but the drug did not become widely used because it cannot be taken with alcohol and only certain certified health care providers are allowed to prescribe it.

According to CNN, Vyleesi’s maker, AMAG Pharmaceuticals, said the new drug will not be available until September, and pricing and reimbursement have yet to be determined.

One expert in female sexual health said it remains to be seen how widely Vyleesi will be used.

“Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it’s more difficult to treat,” Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University’s Center for Women’s Health, told CNN. She had no role in Vyleesi’s development.

Cirini suspects Vyleesi probably will not be the first option women with HSDD turn to, but it might prove a useful adjunct to standard psychotherapy and Addyi.

Vyleesi, like Addyi, probably won’t be overprescribed, Cirino added. When Addyi was introduced, there were concerns “that doctors would just be prescribing this medication to anybody that came in saying that they were having an issue with their libido,” she said. “And I think we have to give physicians more credit than that. In fact, that didn’t happen at all.”

Still, Vyleesi could help some women, Cirino said.

“There’s so many chemical factors that influence our libido,” she told CNN. “So you can’t discount using a chemical treatment as part of the broad approach to low libido.”

More information

There’s more on HSDD at the American Sexual Health Association.

© 2019 HealthDay. All rights reserved.

Posted: June 2019

Drugs.com – Daily MedNews

FDA Approves Second Drug to Help Women With Low Libido

FRIDAY, June 21, 2019 — The U.S. Food and Drug Administration on Friday gave its approval to Vyleesi, the second medication so far approved to help women with low sexual desire.

In a news release, the FDA said that Vyleesi (bremelanotide) is a drug that would be administered by injection prior to having sex.

It’s been specifically approved for premenopausal women with a condition known as acquired, generalized hypoactive sexual desire disorder (HSDD).

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” said Dr. Hylton Joffe, who directs the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.

“Today’s approval provides women with another treatment option for this condition,” Hylton said in the news release.

According to the agency, HSDD is not caused by any medical or psychiatric condition, relationship issues or drug side effects.

Instead, women with HSDD have “previously experienced no problems with sexual desire,” the FDA said. “Generalized HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation or partner.”

The exact way in which Vyleesi helps stimulate sexual desire remains unclear, but it works on melanocortin receptors on cells, the FDA said.

The drug is injected under the skin of the abdomen or thigh at least 45 minutes prior to a sexual encounter, although the best timeframe for dosing could vary from user to user.

Side effects can occur, the FDA added, and include nausea and vomiting, flushing, injection site reactions and headache. Nausea was especially common, affecting 40% of users in the clinical study that led to approval.

That study involved 1,247 premenopausal women with HSDD who received Vyleesi or a placebo in one of two 24-week trials.

“In these trials, about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared to about 17% of those who took placebo,” the FDA noted.

Still, the overall benefit was not large. “There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events. Vyleesi does not enhance sexual performance,” the FDA said.

And there was one other caveat: Vyleesi can hike blood pressure, so people with heart disease or high blood pressure should not take it, the FDA said.

Vyleesi should also not be taken by anyone who is also taking the drug naltrexone, used to combat opioid dependency, because Vyleesi reduces naltrexone’s effectiveness.

Vyleesi is not the first drug approved to enhance flagging libido in women. In 2015 the FDA approved Addyi (flibanserin) for the purpose, but the drug did not become widely used because it cannot be taken with alcohol and only certain certified health care providers are allowed to prescribe it.

According to CNN, Vyleesi’s maker, AMAG Pharmaceuticals, said the new drug will not be available until September, and pricing and reimbursement have yet to be determined.

One expert in female sexual health said it remains to be seen how widely Vyleesi will be used.

“Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it’s more difficult to treat,” Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University’s Center for Women’s Health, told CNN. She had no role in Vyleesi’s development.

Cirini suspects Vyleesi probably will not be the first option women with HSDD turn to, but it might prove a useful adjunct to standard psychotherapy and Addyi.

Vyleesi, like Addyi, probably won’t be overprescribed, Cirino added. When Addyi was introduced, there were concerns “that doctors would just be prescribing this medication to anybody that came in saying that they were having an issue with their libido,” she said. “And I think we have to give physicians more credit than that. In fact, that didn’t happen at all.”

Still, Vyleesi could help some women, Cirino said.

“There’s so many chemical factors that influence our libido,” she told CNN. “So you can’t discount using a chemical treatment as part of the broad approach to low libido.”

More information

There’s more on HSDD at the American Sexual Health Association.

© 2019 HealthDay. All rights reserved.

Posted: June 2019

Drugs.com – Daily MedNews

Few Pregnant Women Get Right Amount of Nutrients

FRIDAY, June 21, 2019 (HealthDay News) — For pregnant women, good nutrition is essential for their health and the baby’s health. But many aren’t getting adequate amounts of the vitamins and minerals they need, a new study finds.

On the other hand, some of actually taking higher levels of nutrients than is healthy, the same research reports.

And almost all are eating too much salt.

“Many pregnant women do not consume enough of key nutrients: specifically, iron, potassium, calcium, magnesium, zinc and vitamins A, C, D, E, K, B6, folate and choline — even with the use of dietary supplements,” said lead researcher Regan Bailey. She’s an associate professor of nutrition science at Purdue University in West Lafayette, Ind.

Almost all pregnant women are at risk of excessive consumption of salt, and many are at risk of excessive consumption of folic acid and iron, especially among those who use dietary supplements, she said.

“It appears that supplements may be necessary for most pregnant women to meet nutrient recommendations,” Bailey said. “However, our findings suggest that responsible formulations of prenatal products could help women achieve recommended intakes without the potential for excess.”

For the study, Bailey and her colleagues collected data on more than 1,000 pregnant women 20 to 40 years old who took part in the U.S. National Health and Nutrition Examination Survey from 2001 to 2014.

The researchers found that nearly 70% of the women were taking prenatal dietary supplements. But based on the recommended levels of the National Academies of Sciences, Engineering, and Medicine Dietary Reference, some weren’t getting enough and some were getting too much.

At least 10% of the women weren’t getting enough magnesium, vitamin D, vitamin E, iron, vitamin A, folate, calcium, vitamin C, vitamin B6 and zinc.

Others were getting too much potassium, vitamin K, folic acid, iron, calcium and zinc.

And 95% were consuming too much salt.

“Whether it’s consuming too much salt or not getting enough of some minerals and vitamins, not adhering to recommended standards is a significant problem,” said Dr. Rahul Gupta, chief medical officer at the March of Dimes.


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White Women Make Gains in Animation Industry Study Reveals

A new study revealed today at the Annecy Film Festival points out to gains made by white women in the animation industry. The in-depth analysis from Dr. Stacy L. Smith and the USC Annenberg Inclusion Initiative, made in partnership in Women in Animation, suggested that although some positive gains have been made, there is much more work to be done, particularly for women of color.

The results of the analysis were presented for the first time today at the Women in Animation World Summit in Annecy. The quantitative study examined animation across film and popular TV series, evaluating the prevalence of women above and below the line in key roles, and in the executive ranks across major companies and studios. The pipeline for women in animation was also assessed across prestigious animation programs and animated short films at premiere festivals. The report also includes a qualitative investigation, which consists of 75 in-depth interviews with early-career women and decision-makers, as well as survey data from more than 250 individuals in the Animation Guild. The report concludes with solutions to inequality in organizations connected to the animation industry.

The quantitative results reveal a few positive trends. First, women comprise roughly half of the executives in animation and fully half of the most powerful positions in major film animation companies and studios. Second, data from animation programs and film festivals reveals that a robust pipeline exists from animation classrooms into early career.

“Another area in which we see some progress is with female producers of animated films,” says Dr. Smith. “In the last 12 years, 37% of producers of animated movies were women, while for live action films, the figure was 15%. The proportion of women in this leadership role in animation, and the progress made in the last decade indicates that there are spaces where the industry is taking inclusion seriously and affecting change. However, only 5% of producers of animated films and 1% of live action producers were women of color. The movie industry is completely out of step with the audience in this regard.”

Data on film directors and unit heads in animated movies and TV series suggest that once women enter the animation field, they opt out or are pushed to other work as they navigate the career paths to this prominent creative job. Only 3% of animated film directors over the last 12 years were women, while 13% of episodes evaluated across popular animated TV programs from 2018 had female directors. Only 1 female film director and 3 female TV directors were women from underrepresented racial/ethnic backgrounds. All four were Asian.

“Women from a variety of racial/ethnic backgrounds were not working as directors across film or TV,” said Dr. Smith. The lack of Black or African American women, Hispanic/Latina women, Native women, or women from Middle East/North African communities, multi-racial or other groups means that the voices and stories of animated films and programs reflect a very narrow demographic of storytellers.

In contrast to film, 20% of executive producers, 17% of co-executive producers, and 34% of producers in TV were women. Only 6 women of color were executive producers, while 8% of producers were women from underrepresented racial/ethnic backgrounds. Seventeen percent of “Created by” or “Developed by” credits in TV were held by women, with just 3 earned by women of color.

In below the line roles, women are still outnumbered in film and TV. Across 52 top animated films from the past 5 years, only 7% of head of story positions were filled with women, as were 8% of animation heads, and 14% of art directors . Women of color held 6%, 3%, and 4% of these positions, respectively. Across 100 popular animated TV series, females comprised 16% of animation directors, 20% of lead animators, and 11% of lead storyboard artists. Slightly higher percentages of women of color were observed in these roles in comparison to film, as 8%, 13%, and 3% of positions across these respective jobs went to women from underrepresented racial/ethnic backgrounds.

“This study validates what we have known all along, that women are a hugely untapped creative resource in the animation industry,” adds Marge Dean, President of Women in Animation. “Now that we have a greater understanding of how the numbers fall into place and what solutions may help rectify this deficiency, we can take bigger strides towards our goal of 50-50 by 2025.”

Results from the qualitative analysis demonstrate the major impediments facing women in the animation industry. Responses indicated that a male-dominated and masculine culture affects females, that the industry view of women is less valuable, and that women are perceived to be less interested in the field. Unique impediments facing women of color were also explored, namely the negative consequences that emerge from being a “token,” including feelings of isolation.

The full report, the latest from the Annenberg Inclusion Initiative, can be found online here.

Increasing Inclusion in Animation: Research Study

Increasing Inclusion in Animation: Research Study

Animation Magazine

Women in Animation, Les Femmes s’Animent Set Annecy Summit Lineup

Women in Animation (WIA) and Les Femmes s’Animent (LFA) have revealed some details of the third annual Women in Animation World Summit, presented in conjunction with the Annecy International Animation Festival and Mifa 2019. The Summit will take place on Monday, June 10 at the Impérial Palace Hotel and will feature a day-long symposium of panels and discussions spotlighting top executives and filmmakers from around the world, exploring the theme of “Belonging.”

The event will kick off with an introduction by Julie Ann Crommett, Vice President of Multicultural Audience Engagement at the Walt Disney Studios and WIA secretary, explaining this year’s theme. A key highlight of the program will be a presentation by Dr. Stacy L. Smith on the results of the USC Annenberg Inclusion Initiative’s landmark study focused on women in the animation industry, entitled “Increasing Inclusion in Animation.”

The study was conducted in partnership with Women in Animation and examines the percentage of women working in key animation roles in film and television, the barriers and opportunities facing women as they pursue careers in animation, and the classroom-to-career pipeline for women.

“For the last year, we have had the honor and privilege to collaborate with Dr. Smith and USC Annenberg on this groundbreaking study,” said WIA President Marge Dean. “We look forward to bringing the findings of this important study to the Annecy Animation Festival, the most important global gathering of the animation industry, and discussing next steps with leaders in the world of animation from then on.”

“Partnering with Women in Animation allowed us to engage in a broad investigation of the animation industry to understand the particular challenges facing women, animation companies, and educational organizations at this juncture,” noted Dr. Smith, Founder & Director of the Inclusion Initiative. “We are excited to share the results of the study and to work together to create solutions that move the industry forward and accelerate change.”

WIA Vancouver Chair Rose-Ann Tisserand will present WIA Vancouver and Women in View’s “BC’s Five in Focus: Animation,” a program featuring the chapter’s innovative program to aid five women across various filmmaking roles in creating original animated shorts. French actress-producer Julie Gayet will also give a keynote address talking about her advocacy for women, both in the film business and society at large, and will share insights from the making of her film Cinéast(e)s.

A series of panels throughout the day will also highlight the theme of “Belonging,” which will address the feeling of being personally accepted, respected, included and supported in the workplace.

“We feel we are now in a new phase in which a more balanced world is taking root,” commented Corinne Kouper, President of LFA. “This change is quite tangible and inevitable, and we never thought this would happen so fast. We are very excited to see new rules and reflexes emerging. I am very happy to explore this year’s joyful theme of increasing our sense of Belonging rather than defining our differences.”

You can find out more about this summit at https://www.annecy.org/programme:evtm

Dr. Stacy L. Smith

Dr. Stacy L. Smith

Animation Magazine

For Women With HIV, Life Can Hurt Fight for Health

By Robert Preidt

HealthDay Reporter

FRIDAY, May 17, 2019 (HealthDay News) — Day-to-day struggles prevent many American women with HIV from taking medicines to suppress the AIDS-causing virus, a new study shows.

“Survival is a priority over putting a pill in your mouth for a number of our participants, and that is the public health challenge we must address,” said study first author Dr. Seble Kassaye, an associate professor at Georgetown University Medical Center in Washington, D.C.

“The truth of their lives is a lot less rosy than a few lines of statistics in a summary report can reveal,” she added in a medical center news release.

The study of nearly 2,000 HIV-positive women in Washington, D.C., New York, Chicago and San Francisco who have been followed since 1994 found that many have been able to control their HIV levels, off and on.

But ongoing challenges such as mental health, unstable housing and lack of social support prevent many from achieving effective and sustained HIV suppression, according to the authors of the study published May 17 in the journal JAMA Network Open.

The women were interviewed and gave blood samples every six months to determine whether their HIV was well controlled or uncontrolled, a condition called viremia.

Over 23 years, 29% were at low probability for viremia; 39% were at intermediate probability; and 32% were at high probability.

Between 2015 and 2017, 71% of women achieved sustained HIV suppression, including 35% with a high probability of viremia, according to the researchers.

“So, the rosy picture is that 71% of the women achieved viral suppression, but the granular detail tells us that some women are doing very well with 89.6% of the women in the low probability of viremia consistently suppressed in the recent years, but others are still struggling to get to viral suppression,” Kassaye said.

Because current HIV drug treatment is much less toxic than it used to be and is now suggested for anyone who has the virus, it’s widely used. But obstacles persist.

The study found that women in the high viremia group were more likely to report depressive symptoms (54%) and have higher levels of illicit drug (41%) and alcohol use (14%). They were also less likely to have stable housing (66%); and more likely to die prematurely (39%).

Continued

Kassaye said public health issues and stigma surrounding HIV remain common in Washington, D.C.

“My colleagues have treated generations of HIV-positive women: grandmothers, their daughters, and their granddaughters,” she said. “I have seen women with HIV who do not have any support, but if that person develops cancer, there will be a roomful of people coming to the clinic with her.”

Achieving universal HIV treatment and viral suppression will require what is known as “wraparound” care, she said.

That’s a term for non-medical services to assist patients who may need help taking medications regularly, getting to appointments on time or coping with stress. This safety net can also include help with housing, transportation, child care and the like, according to the global health strategy firm Rabin Martin.

WebMD News from HealthDay

Sources

SOURCE: Georgetown University Medical Center, news release, May 17, 2019

Copyright © 2013-2018 HealthDay. All rights reserved.

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Pagination

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