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2/28/07 Omalizumab black box warningSummary Findings – On 2/21/07 the FDA called for a “black box” warning to be issued about treatment with Omal. This action apparently relates to reports of a number of cases of anaphylaxis in Omal-treated patients. Some of the anaphylactic reactions were severe. Also, some were delayed in onset so that physicians were directed to observe patients for at least 2 hours after each injection of Omal. On 2/25/07 , Dr. Thomas Platts-Mills, President of the AAAAI, issued the following statement to all AAAAI members. Dear AAAAI Members and Fellows, As many of you have heard, the FDA has issued a notice calling for a black box label warning for Xolair®. The FDA said in its announcement on February 21, 2007 that its action is due to the nature of anaphylaxis reports before and after the drug reached market, including their life-threatening potential, their frequency, and the possibility of delayed onset. The leadership of AAAAI and the ACAAI met Saturday at the AAAAI Annual Meeting in San Diego , California and agreed to appoint a Joint Task Force to review the information and to comment to the FDA about the proposed labeling change in the next couple of weeks.
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