The US Food and Drug Administration MedWatch System Is Activated When

The U.S. Food and Drug Administration MedWatch system is activated when:

A) There is an adverse event to a vaccine.
B) The patient has a severe reaction that is noted in the "Severe Reaction" section in the medication label.
C) A lactating woman takes a medication that is potentially toxic to the breastfeeding infant.
D) An adverse event or serious problem occurs with a medication that is not already identified on the label.