Federal health regulators said Thursday they are reviewing data that suggest the asthma medication Xolair can cause heart attacks, strokes and other potentially deadly problems.
Preliminary results from a study of 5,000 patients taking the drug suggest an increased risk of heart problems and stroke, according to a statement from the Food and Drug Administration. Because of the preliminary nature of the data, the agency said patients should continue taking the drug as directed.
“FDA has not made any conclusions regarding these data,” the agency said. Regulators cautioned that some patients enrolled in the study could have been predisposed to irregular heart rhythms, hypertension and other heart problems.
Genentech, a unit of Swiss pharmaceutical giant Roche, 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 U.S. 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 that cannot be controlled with inhalable treatments.
A spokeswoman for South San Francisco-based Genentech said the company and partner Novartis are “committed to patient safety,” and will continue gathering safety information about the drug. No changes are planned for the drug’s labeling.
“At this time there is insufficient information for the companies to change their assessment of the benefit-risk profile for Xolair,” said Genentech spokeswoman Tara Cooper.
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 on problems with blockbuster drugs like Merck’s painkiller Vioxx.
