The Pharmaceutical Journal
Vol 278 No 7441 p240
3 March 2007

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News summary

Delayed anaphylaxis a risk for omalizumab, warns FDA

Anaphylaxis following omalizumab treatment has occurred in at least 0.1 per cent of treated people (based on reports from approximately 39,500 patients), the US Food and Drug Administration warned last week.

In a safety alert the FDA adds that more recent reports include delayed anaphylaxis — with onset two to 24 hours or more after administration.

The FDA advises health care professionals who administer omalizumab to be prepared to manage life-threatening anaphylaxis and suggests that patients should be observed for at least two hours after treatment has been given.

Patients should also be informed about the signs and symptoms of anaphylaxis, it says.

No similar alert has been issued by the European Medicines Agency, a spokeswoman for the agency said, adding that warnings about anaphylaxis appear in Xolair’s summary of product characteristics.