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.
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