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US FDA asks tough warning on Genentech asthma drug
Feb 23, 07 FDA warningsGenentech Inc’s asthma drug Xolair should carry the strongest warning possible about the drug’s risk of a very severe allergic reaction known as anaphylaxis, which can be fatal without prompt medical attention, U.S. health regulators said on Wednesday.
The Food and Drug Administration said anaphylaxis, which can occur to 24 hours after patients take the drug, also known by the generic name omalizumab. The agency added that doctors and patients should be prepared to treat the reaction, which can cause breathing problems, fainting and hives.
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