Contact Us

Defective Drugs
*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 

Phone 

Cell Phone 

Street Address 

Zip Code 

City 

State 

   * Name of drug: 

Date you started taking this drug:

Date you stopped taking this drug:

Please describe side effects:

For verification purposes, please answer the below question:
+
=

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.


FDA orders warnings for Xolair

Feb 21, 2007 | UPI

The U.S. Food and Drug Administration ordered Genentech Inc. to add a boxed warning to its asthmatic drug marketed as Xolair.

The FDA said the boxed warning should emphasize Xolair (omalizumab) might cause anaphylaxis, including trouble breathing, chest tightness, dizziness, fainting, itching and hives and swelling of the mouth and throat.

In addition, FDA ordered Genentech to revise the Xolair label and provide a medication guide for patients to strengthen the existing warning for anaphylaxis.

Xolair was approved in 2003 to treat adults and adolescents suffering moderate to severe persistent asthma and who have tested positive for a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled steroids.

Although anaphylaxis was reported in about one-in-1,000 patients during clinical trials, the FDA said continued reports prompted it to issue the Wednesday order.


Related articles Other articles
Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo