US reviewing possible heart risks with asthma drug

U.S. regulators are reviewing a possible link between Roche and Novartis AG’s asthma drug Xolair and an increased risk of heart attacks and strokes, health officials said on Thursday.

The possible association was identified based on interim results from a study of Xolair by Roche unit Genentech, the Food and Drug Administration said.

The findings suggested an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke in Xolair patients but still need further review, the FDA said.

Genentech spokeswoman Tara Cooper said limitations in the existing data “preclude a definitive association with Xolair use. At this time, there is insufficient information for the companies to change their assessment of the benefit-risk profile for Xolair.”

The FDA said it was not advising any changes in the prescribing or use of Xolair at the current time.

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* FDA evaluating risks of Roche, Novartis drug Xolair

* Agency not advising changes in use or prescribing

WASHINGTON (Reuters)