SWHR Supports New Requirements for Pregnancy Drug Labeling

SWHR supports Sen. Kohl and FDA on important women’s health legislation

Washington, DC (January 28, 2011) – On Wednesday, Sen. Herb Kohl of Wisconsin furthered a Society for Women’s Health Research (SWHR) long-term advocacy priority with his letter to support new drug labeling and protections for pregnant women. Sen. Kohl and SWHR submitted independent letters with proposed guidelines to the Food and Drug Administration (FDA) regarding the delay in issuing new guidance and labeling for medication use to protect pregnant women.

The requirements outlined in the proposed regulation will give pregnant and nursing women and their clinicians important and detailed information that will improve treatment decisions as well as health outcomes. The case for more comprehensive information on prescription use during pregnancy is clear, and reflects the larger issue of decades of under-studying and under-reporting in women’s health. SWHR has long fought for clinical trials to look at sex differences, as well as racial and ethnic differences in how people react to drugs and biologics.

“SWHR is pleased to support potential revisions to drug labeling in order to protect one of the most vulnerable populations, pregnant women,” said Phyllis Greenberger, M.S.W., President and CEO of SWHR. “Pregnant women and their fetuses need protection from possible harms, but this is only possible when we know how to inform care choices. Without appropriate research and labeling, women are being denied the chance to make informed decisions.”

Nine out of ten medications on the market today have an undetermined risk for use in pregnancy and lactation. An estimated 50% of pregnancies in the U.S. are unplanned, often precluding a woman from stopping or changing potentially hazardous therapies before conceiving. A vast majority of women will use prescription or over-the-counter medications while pregnant.

As the current system for drug risk classification was developed in 1975, SWHR and others believe that the proposed labeling rules, under consideration since 2008 by the FDA, are long overdue. Better information and labeling will substantially advance and augment the health care treatment and procedures for pregnant and nursing women and their children. This large portion of the general population needs added protections and cautions on drugs and biological products, but for too long women and their providers have been forced to make decisions based on limited and inadequate research. SWHR is excited to see and motivate further momentum towards getting this labeling rule passed through FDA.

Click Here to Read SWHR's Comment Letter regarding Pregnancy Drug Labeling.

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For more information on the Society for Women’s Health Research please contact Rachel Griffith at 202-496-5001 or Rachel@swhr.org.

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SWHR Congratulates Sen. Mikulski on Milestone

Mikulski breaks record as longest serving female senator in American history

Washington, DC (January 5, 2011) – On this historic day, the Society for Women’s Health Research (SWHR) applauds Sen. Barbara Mikulski on her milestone as longest serving female senator in American history.

The formidable senator has long been a champion of women’s health and women’s health research. Sen. Mikulski has been a vocal supporter of SWHR’s work to include women in all levels of clinical research and helped create the National Institutes of Health (NIH) Office of Women’s Health after she learned that NIH was not including women in its clinical trials.

“Sen. Mikulski is a true friend of SWHR and a fierce advocate for women’s health and research,” said Phyllis Greenberger, MSW, president and CEO of SWHR. “She has continuously fought for affordable healthcare, the inclusion of women in clinical trials, and consistent funding for women’s health research. We send our heartfelt congratulations to her on this landmark achievement.”

To ensure that women’s health was receiving proper attention at all the federal health agencies, Sen. Mikulski co-sponsored, along with Sen. Olympia Snowe of Maine, the Women’s Health Office Act (WHOA). This landmark legislation was included in the Patient Protection and Affordable Care Act that was signed into law last year. WHOA codified the offices of Women’s Health within the federal agencies, preventing them from being eliminated or underfunded. Further, Sen. Mikulski fought for an amendment to the healthcare legislation that required insurers to cover preventive care and screenings for women at little or no cost to the patient.

The Maryland senator took her oath of office for the 112^th Congress earlier today among friends, family, and distinguished colleagues. Mikulski was born and raised in Baltimore, MD and served as a social worker before entering politics as a member of the Baltimore City Council in 1971.

She first ran for the U.S. Senate in 1974 and lost but was undeterred. Mikulski won her next election to the House in 1976. She was later elected to the Senate in 1987, and then was one of only two women in the Senate at that time. She became a hallmark for women’s rights and a fierce advocate for equality.

Mikulski was re-elected to her fifth term last November with 62 percent of the vote. SWHR extends its congratulations to Sen. Mikulski for this achievement and continued support of women’s health.

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For more information on the Society for Women’s Health Research please contact Rachel Griffith at 202-496-5001 or Rachel@swhr.org.

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Winterize Your Body and Mind

By: Jennifer Wider, MD
January 3, 2011

As the winter months approach bringing holidays and good cheer, certain health issues may arise that women should have on their radar. From mental health issues like stress, depression and seasonal affective disorder (SAD), to physical concerns like skin care, the winter can certainly pack a punch.

Depression peaks during the holiday season, afflicting more than 17 million Americans, according to the National Mental Health Association. On average, women are more vulnerable to stress-related illnesses like depression and anxiety than men. One study, conducted by Pacific Health Laboratories, revealed that 44% of American women report feeling sad through the holidays compared to 34% of American men.

"Depression of any kind is more common in females than males," explains Greg Murray, M.D., lecturer and clinical psychologist at Swinburne University of Technology in Australia. "A pattern of elevated depression in the winter months is more marked in women than in men."

There are a host of different reasons why women may be more susceptible to stress during the holidays than men. Women tend to be the primary caretakers of the family and often take on the extra burden of gift buying, entertaining, and coordinating visits with extended family during the holidays. For working women, the added responsibilities can be difficult to balance, especially if they are already balancing a family, job, child-care and elder-care duties.

In addition to clinical depression, SAD or “winter depression,” affects women more often than men. SAD is a type of depression that usually occurs in the late fall through early spring. The specific cause remains unknown, but many studies point to a disruption in a person’s internal clock due to reduced levels of sunlight. Symptoms of SAD include: depressed mood, lethargy, apathy, changes in sleep or appetite, social withdrawal and difficulty concentrating. According to information from the Mayo Foundation for Medical Education and Research, women are diagnosed more frequently than men yet men tend to have more severe symptoms.

Treatment for SAD is similar to regular depression and can include psychotherapy, medication, and other therapies. Light therapy has been proven effective and involves sitting a few feet away from a specialized light box. The light is supposed to imitate outdoor light and some studies have shown that it actually sparks a change in the brain chemicals that regulate a person’s mood.

The winter months can also wreak havoc on a person’s skin. With the outside cold air and dry indoor heat, many people complain of dry, cracked and flaking skin. Remember these few tips to prevent dry skin during the winter:

• Hydrate: some women forget to drink the recommended 8 glasses of water a day because the temperature has dropped, but hydration is just as important in the winter and will help keep the much needed moisture in your skin.

• Exfoliate: some skin care experts recommend removing the dead skin cells to keep the skin smoother and less dry.

• Moisturize: using a moisturizer during the winter months can help your skin stay soft and less itchy. For people with sensitive skin, hypo-allergenic products are recommended.

• Don’t forget the sunscreen: even though it’s wintertime, sun protection is just as important, especially on the face and hands.

Sources

Alexander JL, Dennerstein L, et al. Women, anxiety and mood : a review of nomenclature, comorbidity and epidmiology. Expert Rev Neurother. 2007. Nov;7(11 Suppl):S45-58.

Privitera MR, Moynihan J, Tang W, Khan A, Light therapy for seasonal affective disorder in a clinical office setting. J Psychiatr Pract. 2010 Nov;16(6):387-93.

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For more information on the Society for Women’s Health Research please contact Rachel Griffith at 202-496-5001 or Rachel@swhr.org.

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