HHS instructs FDA to decline proposal to move Plan B from BTC to OTC
WASHINGTON — The Department of Health and Human Services on Wednesday denied a request made by Teva Pharmaceuticals to relax merchandising restrictions for the emergency contraceptive Plan B. Presently, Plan B can be sold without a prescription to women older than 17 years old but only in a pharmacy and from behind the pharmacy counter. Women younger than 17 years require a prescription to acquire Plan B.
"Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed [the Food and Drug Administration] to issue a complete response letter denying the supplemental new drug application by Teva Women’s Health," stated HHS secretary Kathleen Sebelius.
"This application sought to make Plan B One-Step available over the counter for all girls of reproductive age," she stated. "The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use."
The average age of the onset of menstruation for girls in the United States is 12.4 years, Sebelius noted. However, about 10% of girls are physically capable of bearing children by 11.1 years of age. "It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said. "If the application were approved, the product would be available, without prescription, for all girls of reproductive age."
Study: Irregular work schedules may be contributing factor of diabetes in women
BOSTON — Women who work a rotating schedule that includes three or more night shifts per month, in addition to day and evening working hours in that month, may have an increased risk of developing Type 2 diabetes when compared with women who only work days or evenings, according to a new study led by researchers at Harvard’s School of Public Health that was released Tuesday.
In addition, the researchers found that extended years of rotating night shift work was associated with weight gain, which may contribute to the increased risk of Type 2 diabetes.
Previous studies have focused on the association between shift work and risk of cancer and cardiovascular disease. The HSPH study is the largest study so far to look at the link between shift work and Type 2 diabetes and the first large study to follow women. The findings were published online Dec. 6 in the open access journal PLoS Medicine.
“Long-term rotating night shift work is an important risk factor for the development of Type 2 diabetes, and this risk increases with the numbers of years working rotating shifts,” stated An Pan, research fellow in HSPH’s Department of Nutrition and the study’s lead author.
The researchers analyzed data on more than 69,269 U.S. women, ages 42 to 67 years, in the "Nurses’ Health Study I," tracked from 1988 to 2008, and 107,915 women, ages 25 to 42 years, in the "Nurses’ Health Study II," tracked from 1989 to 2007. About 60% of the nurses performed more than one year of rotating night shift work at baseline; about 11% in "Nurses’ Health Study I" had more than 10 years of rotating night shift work at baseline, and about 4% in "Nurses’ Health Study II" worked more than 10 years of rotating night shifts at baseline, and this proportion increased during the follow-up.
The researchers found that the longer women worked rotating night shifts, the greater their risk of developing Type 2 diabetes. Those women who worked rotating night shifts for three to nine years faced a 20% increased risk, women who worked nights for 10 to 19 years had a 40% rise in risk and women who worked night shifts for over 20 years were 58% more at risk. In addition, women who worked rotating night shifts gained more weight and were more likely to become obese during the follow-up.
After taking into account body weight in the analyses, the increased risk of Type 2 diabetes for women who worked rotating night shifts was reduced but remained statistically significant. For example, women who worked rotating night shifts for more than 20 years had 24% increased risk. These findings indicate that the relationship between night shift work and Type 2 diabetes is partly explained by increased weight.
While the findings need to be confirmed in men and in some ethnic groups (96% of the participants were white Caucasians) and further studies are needed to identify underlying mechanisms for the association, the results are of potential public health significance due to the large number of workers who work rotating night shifts.
According to the U.S. Centers for Disease Control and Prevention, approximately 15 million Americans work full-time on evening shifts, night shifts, rotating shifts or other irregular schedules. Shift work has been shown to disrupt sleeping patterns and other body rhythms and has been associated with obesity and metabolic syndrome, conditions associated with Type 2 diabetes.
CHPA participates in town hall meeting addressing DXM abuse
MIAMI — The Consumer Healthcare Products Association, the Community Anti-Drug Coalitions of America and the Miami Coalition last week held a town hall meeting on preventing teen cough medicine abuse.
The event aimed to raise awareness about the dangers of medicine abuse and included Myriam Masihy from Univision to serve as the mistress of ceremony.
CHPA also has helped to increase awareness around cough medicine abuse through initiatives like its Five Moms website and through a tool kit designed for educators on its Stop Medicine Abuse site, which also is available "en Español."
CHPA’s Emily Skor, VP communications and alliance development, presented on behalf of industry and discussed what parents, grandparents and community leaders can do to prevent teens from abusing medicine. Skor also shared resources from StopMedicineAbuse.org, available in both English and Spanish.