The asthma drug Xolair has been linked to heart failure, blood clots, stroke, heart enlargement and cardiac arrhythmias. The Food and Drug Administration announced Thursday that it will be assessing the preliminary results to determine whether “further regulatory actions are necessary to protect patients.”
The medication has been approved for use by children over the age of 12 and adults who have asthma that is complicated by severe allergies. The issue of a possible connection between the drug and heart ailments came to light as the result of a trial involving 5,000 people taking Xolair and 2,500 participants who were not using the drug.
In 2007, the manufacturer or Xolair, Genentech, was ordered to include a “black box warning” on the packaging to advise patients that the drug may cause potentially fatal anaphylactic reactions. Genetech made $517 million on the sale of Xolair in 2008.