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Comparative Safety of Two Opioid Treatments in Pregnancy Studied

Safety of prenatal exposure to antidiabetics | News | Harvard T.H. Chan School of Public Health

FDA Panelists Slam Agency's Proposed Opioid Trial Design

Advisors said outcomes from an enriched enrollment study would not be broadly generalizable

FDA Panel Gives Unanimous Thumbs Up to OTC Naloxone

Advisory committee members signalled unanimous approval for making naloxone nasal spray available over the counter so the drug can be more accessible to more people.

Opioid Use in Early Pregnancy Not Tied to Most Birth Defects

Feb 15, 2021 FRIDAY, Feb. 12, 2021 (HealthDay News) Opioid use in early pregnancy is associated with a small increase in risk for cleft palate but no increase in risk for most major congenital malformations, and macrolide use in pregnancy is not associated with increased risk for major birth defects in offspring, according to two studies published online Feb. 10 in The BMJ. Brian T. Bateman, M.D., from Brigham and Women’s Hospital in Boston, and colleagues examined the risks of first trimester exposure to prescription opioids for major congenital malformations. Data were included for 1,602,580 publicly insured (MAX) and 1,177,676 commercially insured (MarketScan) pregnant women, of whom 4.4 and 1.1 percent, respectively, had two or more dispensations of any opioid during the first trimester. The researchers found that the absolute risk of malformations was 41.0 versus 32.0 per 1,000 pregnancies exposed to opioids versus unexposed in the MAX cohort and 42.6 versus 37.3 per 1,0