Possible heart problems linked to allergy/asthma drug Xolair
Preliminary results from a study of 5,000 patients taking the asthma drug, Xolair, suggest an increased risk of heart problems and stroke, according to a statement from the Food and Drug Administration. Hoever, because of the preliminary nature of the data, the agency said patients should continue taking the drug as directed.
Regulators pointed out that some patients enrolled in the study could have been predisposed to irregular heart rhythms, hypertension and other heart problems and that no definite data will be avaialble until the completion of a long term study being carried out by Genentech, a unit of Swiss pharmaceutical giant Roche, which is designed the study to track the long-term safety of the drug over five years. Final results are not expected until 2012.
Xolair was first launched in the US in 2003 and is marketed abroad by Swiss drugmaker Novartis. The injectable drug is approved for adults and children older than 12 with moderate to severe asthma.
Xolair was Genentech's fifth best-selling drug last year with revenue of $517 million, according to the company's 2008 annual report.
In general, the FDA has started notifying the public earlier about possible safety issues with drugs, after coming under fire for acting too slowly to act on problems with blockbuster drugs like Merck's painkiller Vioxx.
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First Published in July 2009