Misoprostol

Excerpt

Misoprostol is exclusively approved by the US Food and Drug Administration (FDA) for the prevention and treatment of gastric ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs) in patients who are taking NSAIDs and are at high risk for ulceration. Misoprostol has 4 primary effects, including cytoprotection of the gastrointestinal mucosa, uterotonic properties, diarrhea, and abdominal pain, with the latter 2 considered adverse effects. Misoprostol is indicated, although not FDA-approved, for short-term treatment of active duodenal or gastric ulcers caused by other factors. Despite its global use in gynecology and obstetrics, none of these applications are FDA-approved. The regulatory landscape in the United States has changed since 2022, following the overturn of Roe v. Wade, with state-to-state regulations evolving.