- Email: [email protected]
FDA Blocks OTC Emergency Contraception
Development of the National Institutes of Health. Previously, researchers thought the risk for being infected with the virus from breastmilk diminished as an infant grew older. The analysis determined that a significant proportion of infants—42 percent—were infected by breastfeeding after they were four weeks old. The study also found that infants were at greater risk for contracting the virus through breastfeeding if their mothers had low levels of CD4+ cells, an immune cell targeted by the AIDS virus. Moreover, male infants were more likely to contract the virus through breastfeeding than were female infants. The analysis appeared in the June 15 issue of The Journal of Infectious Diseases. Researchers indicated that the findings might be useful in devising new strategies to prevent infected mothers from passing HIV to their infants through breastmilk. Such strategies are essential, she said, as many women in poor countries don’t have the option of formulafeeding their infants. In some areas, formula may be too expensive for women to afford. Other areas may lack clean water, and mixing formula with local water may place infants at greater risk of contracting oftentimes fatal diarrheal diseases. In other areas, it may be socially unacceptable for women not to breastfeed their infants. In such areas, she explained, choosing not to breastfeed—or any other sign that a woman is infected with HIV—may result in adverse consequences for the woman, such as being the victim of domestic violence. The researchers discussed possible strategies for preventing the virus from spreading through breastmilk, such as giving anti-HIV drugs to mothers who are breastfeeding. Similarly, such drugs might be given to infants while they are breastfeeding.
Prenatal Thyroid Screening Proves Beneficial
R
Carolyn Davis Cockey, MLS, is executive editor of AWHONN Lifelines and the associate director of publications for AWHONN.
308
AWHONN Lifelines
outine thyroid screening for women of reproductive age, particularly before they become pregnant, may save money and limit health risks to children, according to new research presented mid-summer at The Endocrine Society’s 86th Annual Meeting. The new findings provide a basis for quantifying costs and assessing effectiveness of different
thyroid screening strategies for reproductiveage women. Previous research has shown that low levels of thyroid hormone in pregnant women can cause mildly impaired development in their children. As a result, some experts have advocated screening women of childbearing age for thyroid disease. To assess the potential cost and impact of screening, researchers gathered data from 5,516 women ages 17 to 45 from the Third National Health and Nutrition Examination Survey (NHANES III) performed by the National Center for Health Statistics at the Centers for Disease Control and Prevention of America. They found that low thyroid hormone levels affect an estimated 40,000 pregnant and 1.6 million nonpregnant women in the U.S. They also concluded that 3.1 percent of reproductive-age women in the U.S. have low thyroid hormone levels. Presenting their findings, researchers noted that “previous studies have focused on the prevalence of low thyroid hormone levels in women who already know they are pregnant, rather than the prevalence in women who do not realize they are pregnant or could become pregnant. During the first 12 weeks of pregnancy, fetal brain development relies on maternal thyroid hormone; therefore a targeted screening of women before they become pregnant may prove effective in preventing developmental problems.”
FDA Blocks OTC Emergency Contraception
T
he Food and Drug Administration (FDA) halted Barr Lab’s efforts to make the Plan B emergency contraception product available without a prescription by issuing a “not approvable” letter, all the while supplying Barr with additional information that would be required to gain approval to market Plan B over the counter (OTC). The FDA based its action primarily on the lack of data concerning OTC use of the product among adolescents younger than 16 years old. The sponsor’s application contained no data in participants under 14 years of age and very limited data in adolescents 14 to 16 years old.
Volume 8
Issue 4
The FDA’s letter to the sponsor notes that the application does not provide adequate data to support use of Plan B by young adolescent women without the intervention of a physician. The letter also points out that the sponsor’s March 11 amendment of its application to allow marketing of Plan B by prescription only to young women under 16 years of age was not complete. As a result, the agency was unable to do a complete review on that amendment during this review cycle. Although U.S. law prohibits the FDA from discussing pending applications because they contain commercial confidential information, in this instance the sponsor of Plan B, Barr Research, has allowed the FDA to comment in general terms on the status of Barr’s application to make Plan B available as an OTC product, and on
the agency’s action. To read more about the FDA’s action, go to www.fda.gov/cder/drug/ infopage/planB/default.htm.
Women Seek Options Regarding Heavy Periods
A
ccording to a new online survey of women with heavy periods, women have strong opinions about what they want—and what they don’t want—to do to manage their heavy periods. Even though hormonal therapy, such as birth control pills, is one of the most frequently prescribed treatments, more than 65 percent of women surveyed said they want to avoid taking hormones, and 60 percent agree that they would prefer not to take a pill on a daily basis for this condition, according to some 400 women
Nurses Speak Out! Take the Poll: Do you discuss cardiovascular health promotion strategies with your patients? • Yes: 46% (n=210) • No: 54% (n=240) Survey results of online poll hosted at www.awhonn.org from 4/1/04 through 6/10/04; 450 total respondents. Want to share your opinion? Log onto www.awhonn.org and “Take the poll” on the homepage.
who took a survey hosted by manufacturer Gynecare. Menorrhagia—or heavy periods so debilitating that they interfere with normal activities—plague as many as 22 percent of otherwise healthy premenopausal women over age 35. While a period typically lasts four to five days, and the average amount of blood loss is 60 to 250 milliliters per cycle, women with heavy periods will lose 10 to 25 times that amount. According to the women surveyed, physicians are most likely to propose hormonal treatments, such as birth control pills or a dilation and curettage (D&C). Although a common treatment, D&C provides only temporary relief of heavy bleeding. The women surveyed reveal that as many as one in five physicians have recommended a hysterectomy as treatment for menorrhagia. Of the more than 600,000 hysterectomies performed in 1999 alone, more than one-third of them were to treat fibroids and heavy uterine bleeding. The women surveyed expressed hesitation and concern about the main treatment options recommended, including hormonal therapy (such as birth control pills) and more invasive procedures like hysterectomy. The survey of 400 women who selfidentified as having heavy periods revealed that heavy bleeding is not the only life-impacting side effect of this condition—75 percent of sufferers also experience at least one of the following: • • • •
mood swings cramps/pain fatigue bloating or tenderness
Despite other side effects, heavy bleeding is what causes staining, one of the most embarrassing and frustrating aspects of living with menorrhagia. Nine out of 10 women surveyed cope by avoiding whites and wearing darks as well as staying away from thin or silky fabrics. More than half admit to wearing long shirts, wrapping shirts
August | September 2004
AWHONN Lifelines
309
Prenatal Thyroid Screening Proves Beneficial
R
Carolyn Davis Cockey, MLS, is executive editor of AWHONN Lifelines and the associate director of publications for AWHONN.
308
AWHONN Lifelines
outine thyroid screening for women of reproductive age, particularly before they become pregnant, may save money and limit health risks to children, according to new research presented mid-summer at The Endocrine Society’s 86th Annual Meeting. The new findings provide a basis for quantifying costs and assessing effectiveness of different
thyroid screening strategies for reproductiveage women. Previous research has shown that low levels of thyroid hormone in pregnant women can cause mildly impaired development in their children. As a result, some experts have advocated screening women of childbearing age for thyroid disease. To assess the potential cost and impact of screening, researchers gathered data from 5,516 women ages 17 to 45 from the Third National Health and Nutrition Examination Survey (NHANES III) performed by the National Center for Health Statistics at the Centers for Disease Control and Prevention of America. They found that low thyroid hormone levels affect an estimated 40,000 pregnant and 1.6 million nonpregnant women in the U.S. They also concluded that 3.1 percent of reproductive-age women in the U.S. have low thyroid hormone levels. Presenting their findings, researchers noted that “previous studies have focused on the prevalence of low thyroid hormone levels in women who already know they are pregnant, rather than the prevalence in women who do not realize they are pregnant or could become pregnant. During the first 12 weeks of pregnancy, fetal brain development relies on maternal thyroid hormone; therefore a targeted screening of women before they become pregnant may prove effective in preventing developmental problems.”
FDA Blocks OTC Emergency Contraception
T
he Food and Drug Administration (FDA) halted Barr Lab’s efforts to make the Plan B emergency contraception product available without a prescription by issuing a “not approvable” letter, all the while supplying Barr with additional information that would be required to gain approval to market Plan B over the counter (OTC). The FDA based its action primarily on the lack of data concerning OTC use of the product among adolescents younger than 16 years old. The sponsor’s application contained no data in participants under 14 years of age and very limited data in adolescents 14 to 16 years old.
Volume 8
Issue 4
The FDA’s letter to the sponsor notes that the application does not provide adequate data to support use of Plan B by young adolescent women without the intervention of a physician. The letter also points out that the sponsor’s March 11 amendment of its application to allow marketing of Plan B by prescription only to young women under 16 years of age was not complete. As a result, the agency was unable to do a complete review on that amendment during this review cycle. Although U.S. law prohibits the FDA from discussing pending applications because they contain commercial confidential information, in this instance the sponsor of Plan B, Barr Research, has allowed the FDA to comment in general terms on the status of Barr’s application to make Plan B available as an OTC product, and on
the agency’s action. To read more about the FDA’s action, go to www.fda.gov/cder/drug/ infopage/planB/default.htm.
Women Seek Options Regarding Heavy Periods
A
ccording to a new online survey of women with heavy periods, women have strong opinions about what they want—and what they don’t want—to do to manage their heavy periods. Even though hormonal therapy, such as birth control pills, is one of the most frequently prescribed treatments, more than 65 percent of women surveyed said they want to avoid taking hormones, and 60 percent agree that they would prefer not to take a pill on a daily basis for this condition, according to some 400 women
Nurses Speak Out! Take the Poll: Do you discuss cardiovascular health promotion strategies with your patients? • Yes: 46% (n=210) • No: 54% (n=240) Survey results of online poll hosted at www.awhonn.org from 4/1/04 through 6/10/04; 450 total respondents. Want to share your opinion? Log onto www.awhonn.org and “Take the poll” on the homepage.
who took a survey hosted by manufacturer Gynecare. Menorrhagia—or heavy periods so debilitating that they interfere with normal activities—plague as many as 22 percent of otherwise healthy premenopausal women over age 35. While a period typically lasts four to five days, and the average amount of blood loss is 60 to 250 milliliters per cycle, women with heavy periods will lose 10 to 25 times that amount. According to the women surveyed, physicians are most likely to propose hormonal treatments, such as birth control pills or a dilation and curettage (D&C). Although a common treatment, D&C provides only temporary relief of heavy bleeding. The women surveyed reveal that as many as one in five physicians have recommended a hysterectomy as treatment for menorrhagia. Of the more than 600,000 hysterectomies performed in 1999 alone, more than one-third of them were to treat fibroids and heavy uterine bleeding. The women surveyed expressed hesitation and concern about the main treatment options recommended, including hormonal therapy (such as birth control pills) and more invasive procedures like hysterectomy. The survey of 400 women who selfidentified as having heavy periods revealed that heavy bleeding is not the only life-impacting side effect of this condition—75 percent of sufferers also experience at least one of the following: • • • •
mood swings cramps/pain fatigue bloating or tenderness
Despite other side effects, heavy bleeding is what causes staining, one of the most embarrassing and frustrating aspects of living with menorrhagia. Nine out of 10 women surveyed cope by avoiding whites and wearing darks as well as staying away from thin or silky fabrics. More than half admit to wearing long shirts, wrapping shirts
August | September 2004
AWHONN Lifelines
309