Omalizumab may come with a warning label, FDA recommends
The Food and Drug Administration (FDA) has requested Genentech, Inc. for a boxed warning on the product label for omalizumab, marketed as Xolair.
This warning is concerned about a potential side effect, anaphylaxis. Anaphylaxis may include troubled breathing, chest tightness, dizziness, fainting, itching, and hives.
Genentech was asked by the FDA to provide a Medication Guide for [...]