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Petition Calls for Sentinel Query on Off-Label Use of Ulcer Drug

May 8, 2017

A health advocacy group has petitioned the FDA to conduct a Sentinel query on off-label uses of misoprostol.

The Tatia Oden French Memorial Foundation has urged the agency to assess the risks posed by the drug, marketed as Cytotec.

Indicated for treatment of peptic ulcers, the drug is often used off-label to induce labor, according to the petition, but evidence suggests links to serious adverse events.

At least two pregnant women have died after off-label use of Cytotec and research suggests the uses can cause conditions like amniotic fluid embolism, vaginal hemorrhage and fetal distress, the foundation said.

The FDA published a patient information sheet on the risks associated with the off-label uses in 2005, and in 2012 the agency approved Cytotec labeling, noting the potential risks of off-label use by pregnant women. A full Sentinel query, the petition argues, would help FDA determine whether the labeling and patient information sheet have been effective in preventing adverse events.

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