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25 Drugs, Drug Classes Added to FDA’s Safety Signal List

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The US Food and Drug Administration (FDA) has added 25 drugs or drug classes to its quarterly list of agents in which it has found a potential sign of serious risk or new safety information.

The new list, created from the FDA Adverse Event Reporting System (FAERS), covers April through June, and is current as of October 5.

One large category in this update was the glucagon-like peptide 1 (GLP-1) receptor agonists for type 2 diabetes. The 12 drugs listed in the category had a potential safety signal for hypoglycemia. The FDA is evaluating whether it needs to take regulatory action.

Again this quarter, proton pump inhibitors (PPIs) were prominent on the list. This time the safety signal was hypocalcemia and parathyroid hormone disorders for the 11 drugs listed. The FDA is evaluating whether action is needed for this category as well.

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’s 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.