Prescribing information revised to include a BOXED WARNING and MEDICATION GUIDE about the risk of anaphylaxis when taking Xolair.
FDA Warning on Sleep Medications: Ambien, Lunesta, Restoril, Others
The FDA has issued stronger warnings on sleep medications, such as Ambien, Lunesta, and Restoril, and has asked the drugs manufacturers to place stronger warnings on the package labels.
The agency cites concerns such as allergic reactions, and sleep walking and "sleep driving" in its statement.
Source: Food and Drug Administration (FDA)
P07-45
FDA Approved Humira for Chron’s Disease
The Food and Drug Administration (FDA) today approved Humira (adalimumab) to treat adult patients with moderately to severely active Crohn’s disease, a chronic inflammatory disease of the intestines, which affects an estimated one million Americans.
Humira is a human-derived, genetically-engineered monoclonal antibody (a protein that can be produced in large quantities in a manufacturing plant). The product acts to reduce excessive levels of human tumor necrosis factor (TNF) alpha, which plays an important role in abnormal inflammatory and immune responses.
The labeling includes a boxed warning about potential serious adverse events.
Source: FDA