Xolair Black box warning, more info?

[Guest guest]

Saw this article. Are they really suggesting that everyone wait 2

hours in doctors' offices? There must be more specific guidance on

these rare occurrances:

MedWatch: Anaphylaxis May Occur After Taking Xolair

BETHESDA, MD -- February 21, 2007 -- FDA notified asthmatic patients

and healthcare professionals of new reports of serious and life-

threatening allergic reactions (anaphylaxis) in patients after

treatment with Xolair.

Usually these reactions occur within two hours of receiving a Xolair

subcutaneous injection. However, these new reports include patients

who had delayed anaphylaxis-with onset two to 24 hours or even longer-

after receiving Xolair treatment.

Anaphylaxis may occur after any dose of Xolair (including the first

dose), even if the patient had no allergic reaction to the first dose.

Health care professionals who administer Xolair should be prepared to

manage life-threatening anaphylaxis and should observe their Xolair-

treated patients for at least two hours after Xolair is given.

Patients under treatment with Xolair should be fully informed about

the signs and symptoms of anaphylaxis, their chance of developing

delayed anaphylaxis following Xolair treatment, and how to treat it

when it occurs. FDA has requested Genentech add a boxed warning to

the product label and to revise the label and provide a Medication

Guide for patients.

SOURCE: Food and Drug Administration