Evidence that Genentech’s asthma drug Xolair (omalizumab) might cause heart attacks and strokes is being reviewed by the US Food and Drug Administration (FDA).
But it says that patients should continue taking the medication amid suggestions that patients who took part in a trial may have been predisposed to suffer heart conditions.
The FDA has begun issuing warnings about possible safety issues earlier after being criticised for acting too slowly on problems with blockbuster drugs like Merck’s painkiller Vioxx.
Genentech, part of Swiss pharmaceutical giant Roche, designed the trial to track the safety of the drug over five years, and results are not expected until 2012.
Xolair was Genentech’s fifth best-selling drug last year, with revenue of $517 million. Marketed worldwide by Swiss drugmaker Novartis, it launched in the US in 2003 for adults and children older than 12 with moderate to severe asthma.
A spokesman for San Francisco-based Genentech says the company is “committed to patient safety”, and will continue gathering information about the drug.
Copyright Press Association 2009