21 février, 2007 17:41
FDA Orders Stronger Warnings For Xolair
Asthma Drug Reported To Cause Delayed Life-Threatening Reaction In Some Patients
(AP) The government ordered stronger label warnings for an injected asthma medication Wednesday because of reports some patients taking the drug, marketed as Xolair, had suffered a delayed and potentially life-threatening reaction known as anaphylaxis.
A patient experiencing anaphylaxis might have trouble breathing, feel tight in the chest, have swelling in the mouth and throat, suffer dizziness or feel faint, or have itching and hives.
But the Food and Drug Administration ordered the drug's manufacturer, Genentech, Inc., to strengthen the label warnings because of reports of patients having a delayed reaction of anaphylaxis or reacting to a subsequent dose even when they had no problems after a first dose.
The new warning says:
Doctors should observe patients for at least two hours after the drug is injected and be ready to manage a potentially life-threatening reaction.
Anaphylaxis can occur even if a patient did not react to a previous Xolair injection.
Anaphylaxis can occur up to 24 hours after the injection is given.
Patients using Xolair should be prepared for to treat themselves for anaphylaxis in emergency situations.
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Comments
DRinUK... please understand the facts before you "shoot off at the hip!" First of all, Xolair has revolutinized asthma care. It has saved so many people's lives. People that were unable to walk because of their asthma are free to walk again. Xolair is indicated for moderate to serve asthma. The rate of anaphlyaxis is .1% in Xolair treated patients and 5% in patients receiving allergy shots. Allergy shots have been around for 50 years. The FDA is not going to approve Xolair unless it provides clinical benefit for patients. So... get your facts straight and learn, learn and learn before you open your mouth! Posted by John3535 at 08:59 AM : Feb 22, 2007
It's gotta be bad when the FDA comes out with a warning against a drug company but why not pull it off the shelf ? Why was it approved in the first place? Yet another load of poison which got through to public use on the say so of the manufacturer. Did the FDA check this product ?
