Posted by on August 26, 2010 - 2:57pm

A recent Food and Drug Administration (FDA) MedWatch Safety Alert warns women to make sure children and pets do not come into contact with Evamist that they have sprayed on their skin.    Evamist is a transdermal spray containing estradiol, a form of estrogen. It is sprayed inside of the forearm between the elbow and wrist to reduce hot flashes during menopause. Each squirt of spray delivers 90 mcL which contains 1.53 mg of estradiol and is FDA approved for this use.

The FDA has received reports of side effects in children who were unintentionally exposed to Evamist.   Side effects include:

  • nipple swelling and breast development in girls
  • Breast enlargement in boys

FDA has also received reports of unintentional exposure in pets, which may show signs of mammary/nipple enlargement and vulvar swelling.

The FDA recommends that you do not allow children to come in contact with area of the arm where Evamist was sprayed.  If a child is exposed to Evamist, wash the child's skin with soap and water as soon as possible.      Contact the child's health professional if nipple or breast swelling or breast tenderness occurs in girls, or breast enlargement occurs in boys.    Do not allow pets to lick or touch the arm where Evamist was sprayed.   Small pets may be especially sensitive to Evamist.   Contact a vet if your pet shows any signs of illness, including enlargement of the nipples or vulva.

Women who use Evamist should wear clothing that covers the arm sprayed with the drug if they cannot prevent accidental contact.

The FDA

Posted by on August 23, 2010 - 9:15am

No, you did not open the wrong page.   Yes, this blog is posted by the Institute for Women's Health Research at Northwestern. As an advocate for better  sex and gender based research, we support all avenues that increase our knowledge about sex differences and that includes  a better understanding of  hormone changes in women AND MEN.

Furthermore, women are generally the source of health information for their families and that includes their male partners! So, women and men, read on!

Low testosterone levels to blame for low libido, fatigue and weight gain

While most frequently associated with women’s health, age-related hormone changes, often dubbed menopause, can occur in men as well, causing symptoms of fatigue, mood swings, decreased desire for sex, hair loss, lack of concentration and weight gain. Experts estimate that more than 5 million men are affected, yet worry the number may be considerably higher since symptoms are frequently ignored.  Male hypogonadism, as it’s referred to in the medical community, occurs when the testicles do not produce enough testosterone, the hormone that plays a key role in masculine growth and development. When hormone levels drop, men can experience significant mental and physical changes.

“This is a highly prevalent disorder,” said Robert Brannigan, MD, urologist at Northwestern Memorial Hospital. “Unfortunately, we estimate that 95 percent of cases are undiagnosed and therefore untreated. When ignored, symptoms can seriously disrupt one’s quality of life.”

Brannigan explains hormone variations are a normal aspect of getting older. “In females, ovulation comes to an end and hormone production declines in a relatively quick period of time, whereas men experience hormone shifts more slowly, with testosterone levels dropping around one percent each year beginning in a man’s late thirties,” adds Brannigan. He goes on to explain that by age seventy, the reduction in a male’s testosterone level could be as high as fifty percent or more compared to baseline levels, but notes that aging men are not the only ones at risk. A number of genetic causes can impact males from birth and are usually diagnosed with failure to progress normally through puberty during the teenage years.

Treatment options for male hypogonadism include hormone replacement therapy (HRT) via absorbable pellet implants, topical gels, patches, and injections. Through HRT, doctors can restore sexual function and muscle strength. In addition, men often experience an increase in energy and an improved overall sense of well-being.

“We are seeing more men affected by male hypogonadism than we saw ten years ago,” said Brannigan. “However, many men continue to suffer in silence due to a lack of awareness surrounding the disorder. Because male hypogonadism can significantly impact the quality of one’s life, it’s important that men pay attention to their body and openly discuss symptoms with their physician in order to prevent overlooking the cause and avoid missing an opportunity for appropriate therapy.”

Although research to determine the exact association continues, doctors also warn that male hypogonadism has been linked to chronic medical conditions such as high cholesterol, diabetes and cardiovascular disease. It’s also closely associated with infertility.

“This disorder is not something that should be ignored,” said Brannigan, who is working to educate patients and physicians about the symptoms and treatments available in order to ensure therapies are made available to men in need.

Male hypogonadism is most commonly diagnosed through a simple blood test. Brannigan notes hormone replacement therapy is not appropriate for all patients especially those with history of prostate and breast cancer and men trying to conceive. He suggests consulting your doctor if you are experiencing symptoms.

Posted by on August 10, 2010 - 3:36pm

Women's cholesterol levels vary with phase of menstrual cycle
NIH findings suggest a need to consider phase of cycle when measuring cholesterol

National Institutes of Health researchers have shown that women's cholesterol levels correspond with monthly changes in estrogen levels. This natural variation, they suggest, might indicate a need to take into account the phases of a woman's monthly cycle before evaluating her cholesterol measures. On average, the total cholesterol level of the women in the study varied 19 percent over the course of the menstrual cycle.

In a typical cycle, estrogen levels steadily increase as the egg cell matures, peaking just before ovulation. Previous studies have shown that taking formulations which contain estrogen — oral contraceptives or menopausal hormone therapy — can affect cholesterol levels. However, the results of studies examining the effects of naturally occurring hormone levels on cholesterol have not been conclusive. According to the NIH’s National Heart, Lung and Blood Institute, high blood cholesterol levels raise the risk for heart disease.

The researchers found that as the level of estrogen rises, high-density lipoprotein (HDL) cholesterol also rises, peaking at the time of ovulation. HDL cholesterol is believed to be protective against heart disease.

In contrast, total cholesterol and low-density lipoprotein (LDL) cholesterol levels — as well as another form of blood fat known as triglycerides — declined as estrogen levels rose. The decline was not immediate, beginning a couple of days after the estrogen peak at ovulation. Total cholesterol, LDL cholesterol and triglyceride levels reached their lowest just before menstruation began.

The findings were published online in The Journal of Clinical Endocrinology and Metabolism.  To read the full NIH Press Release click here.

Posted by on February 17, 2010 - 2:22pm

On February 15, 2010 the NIH issued a news release about a new analysis reported in the Annals of Internal Medicine on data from the Women's Health Initiative (WHI).  The study reevaluated whether or not combination hormone therapy (estrogen+progestin) increases the risk of heart disease in healthy postmenopausal women. Researchers from the National Heart, Lung, and Blood Institute (NHLBI) and the Harvard School of Public Health reanalyzed data from the WHI, comparing the effects of hormone therapy (HT) on heart disease risk among women who began hormone therapy within 10 years of menopause to women who began therapy more that 10 years after menopause. Recently, there has been a lot of debate among clinicians and researchers whether or not the time between the start of menopause and the initiation of hormone treatment affects the cardiovascular risk.  Some believed that the risk may not be present in women who start HT shortly after they go into menopause.  In this new study,  the researchers compared women who started combination hormone (estrogen+progestin) treatment within 10 years of menopause to women who began therapy more than 10 years after menopause and examined the impact on heart disease over time (up to eight years). The new study did not include women who took estrogen only.

The researchers reported a trend toward a possible increased risk of heart disease in the first two years among the women who started hormone therapy within 10 years after menopause and the increased risk persisted in this group an average of 6 years, after which those in the treatment group appeared to have a lower risk of heart disease compared to similar women who were not on combination hormone therapy.  In contrast, women who started hormone therapy 10 years or more after menopause were nearly 3 times more likely to develop heart disease within the first two years of treatment compared to women on placebo.   These women continued to be at increase risk of health disease throughout the 8 years of follow-up.

Jacques E. Rossouw, MD, chief of the NHLBI Women's Health Initiative Branch and a coauthor of the paper, added,  "Although the number of recently menopausal women who would be expected to suffer a heart attack during the first years of combination HT is small, the risk is likely to be real." In the NHLBI press release, acting director, Susan B. Shurin, MD, said, "Today, most women who take hormone therapy for menopausal symptoms begin therapy shortly after menopause.  Based on today's study, even these women appear to be at increased risk of heart disease for several years after starting combination hormone therapy."  This new data reinforces the need for women to  discuss their potential risk for cardiovascular disease and for other conditions like stroke and  breast cancer with their doctors when considering combination HT.

So what have we learned from this study?    Women who start combination HT to treat the symptoms of menopause within 10 years of menopause, should not expect the treatment to protect them from heart attacks, and may even have a possible slight increase in risk.   As with many studies, the statistical significance of the women in the study may not be sufficient to make this the final word on the topic but it is unlikely that additional information on the scale of this study will be available in the near future.

Posted by on December 11, 2009 - 4:35pm

Health.com published an article today that summarizes the findings of a recent study on menopause and cholesterol that shows women's cholesterol levels increase at the time of menopause. The study's abstract can be found here, at the Journal of the American College of Cardiology site.

Image: heart-valve-surgery.com

Image: heart-valve-surgery.com

It isn't news that cholesterol and other risks of heart disease increase as women age, but the study wanted to determine if the cholesterol increase was due to simple aging, or more specifically related to menopause. They found that within two years of a woman's last period, her LDL cholesterol (so-called bad cholesterol) jumps about 10 points. This increase may be small, but if a woman already has elevated cholesterol, it could be problematic. Additionally, since other risk factors for heart disease increase with age, this increase in cholesterol could team with other cardio-related age affects to create an increased risk of heart problems. The study authors suggest that peri-menopausal women take this news under advisement and become even more vigilant about their diet and exercise routines.

This study is not only interesting because of the findings, but also because of the methodology they employed; the researchers used self-reported data from a national health registry to conduct their study. The Study of Women's Health Across the Nation (SWAN) is very akin to our state based registry, the Illinois Women's Health Registry (if you live in Illinois, go join!). Analysis of these surveys and normal everyday women who participated pulled out this very interesting finding. It's quite clear that this is a great example of why gender-based research is so necessary, study of cholesterol rates in an all-male study group would never have discovered this connection! Finally, the study concluded that the link between increased cholesterol and menopause was true for most ethnicities...because they included women from many ethnicities! It's amazing how much more we learn when diverse participants are used for clinical research studies!

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