Experts advised the FDA to withdraw a preterm birth treatment from the market; the Novavax booster for COVID-19 was approved by US regulators on Wednesday; allergy medication was found to be commonly present in those who died of an opioid overdose.
A panel of experts voted 14-1 to recommend withdrawing hydroxyprogesterone caproate (Makena), a treatment intended to prevent preterm birth, from the market, according to The Washington Post. The decision came as the panel of experts concluded that Makena was not an effective treatment. The drugmaker Covis Pharma, as well as some clinicians and patient groups, argued in the 3 days of hearings that the drug may work in a narrower population, including African American women. The FDA experts concluded that no data supported this argument. Although the recommendations of the panel do not constitute an official FDA decision, the FDA tends to follow the direction of the panel.
The FDA approved the Novavax COVID-19 booster to be used in adults 18 years and older, according to AP News. The FDA said that this booster is aimed at adults who cannot get the updated versions of the Pfizer and Moderna boosters that target the Omicron variant, whether it be for accessibility or medical reasons. The Novavax booster will be exclusively used as a first booster and cannot be used for people who have already had 1 or more boosters since their primary shot. The Novavax booster is a protein-based vaccine rather than a vaccine using mRNA, as the Pfizer and Moderna vaccines are.
Allergy medications, such as antihistamines, could be involved in the death toll of the opioid epidemic, according to USA Today. A total of 18% of people who died of a drug overdose between 2019 and 2020 also tested positive for antihistamines. More than 71% of the people who died had diphenhydramine, or Benadryl, in their bodies at the time of death. Drugs like diphenhydramine, which are sedating antihistamines, can exacerbate respiratory depression caused by opioids, which can lead to decreased breathing in the victim. Opioid overdoses can be treated with naloxone, but naloxone has no effect on antihistamines, which can lead to lethal outcomes.
New Research Links Gender, Racial Microaggressions to Higher Postpartum Blood Pressure
January 9th 2025Acts of discrimination, including subtle microaggressions, during pregnancy and childbirth contribute to higher maternal mortality rates, especially among Black women, and are linked to increased postpartum blood pressure, highlighting the need for improved health care interventions and racial equity in maternity care.
Read More
Advancing Women's Health: CVS Health Leader on Access, Technology, and Breaking Stigmas
December 5th 2024On this episode of Managed Care Cast, we speak with CVS Health's vice president and chief medical officer for women's health and genomics about advancements and challenges in women's health, focusing on care access, technology, and maternal outcomes.
Listen
Infant Mortality Increases Across US Following Dobbs Decision
October 25th 2024The Dobbs decision was associated with a 7% absolute increase in overall infant mortality—equivalent to 247 excess deaths—and a 10% increase among infants with congenital anomalies, corresponding to 204 additional deaths.
Read More
Cost Barriers Continue to Limit Access to Fertility Care
October 24th 2024Of the 10% of women contacted for this survey who said that they or their partner had ever sought fertility assistance, only 7% were able to get the necessary care; cost was cited as the top reason for not being able to access fertility services.
Read More