Antibiotics and antidepressants are the most common drugs on the FDA’s recently updated watch list. The list contains drugs or drug classes that may be associated with new safety information or signs of serious side effects.
Eleven antibiotics that may be associated with a hypoglycemic coma risk and 9 antidepressants may pose a potential DRESS (drug reaction with eosinophilia and systemic symptoms) risk.
The list does not verify that the FDA has detected the risks listed on an adverse event report, but rather informs consumers about the potential safety problems.
Should future studies find that the drugs are associated with the risks listed, the FDA can require changes to labeling, restrict use of the drug, or pull the product off the shelves.
There are 2 drugs on the list where the potential side effects have prompted changes to the label. (Imbruvica) Ibrutinib capsules, a medication used to treat certain cancers, received a label update to indicate a ventricular arrhythmia risk. Another, Uptravi (selexipag) tablets, is used to treat hypertension. The drug’s label was updated to include the risk of hypotension.