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The new watch list from the US Food and Drug Administration (FDA) includes almost two dozen drugs or drug classes for which there is a potential sign of serious risk or new safety information.
The watch list, updated to cover the period from October 2019 to March 2020, is generated from the FDA Adverse Event Reporting System and is posted on the FDA website.
Just because a drug appears on the list does not mean the FDA has found that it is associated with the corresponding risk, only that the agency has identified a potential safety problem. If further review shows that it is associated with risk, the FDA can take action — including requiring label changes, restricting the drug's use, or, in rare cases, removing it from the market.
Many proton pump inhibitors (PPIs) were listed; for some, more than one potential risk were identified. One group of 10 PPIs was associated with potential risk for the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Another group of 13 PPIs was associated with potential acute generalized exanthematous pustulosis (AGEP).
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