Since FDA Early Communication About An Ongoing Safety Review Of Xolair Was Issued In 2009, The Agency Has Been Examining Xolair Safety Profile But FDA Is Still Unsure If This Drug Is Safe Or Not
UPDATE: "Xolair Is Associated With Higher Than Expected Reporting Of Arterial Thrombotic Events Such As Strokes And Cardiovascular Deaths"
In late September 2014 we learned more about serious side effects that have been linked to Xolair since this injectible drug for certain patients with asthma or chronic hives was approved in 2003. The drug companies responsible for Xolair are Genentech and Novartis Pharmaceuticals.
From this document, "FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events", we get the latest news on this Xolair drug safety issue:
A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain.... As a result, we have added information about these potential risks to the drug label....
Our review of a 5-year safety study found a slightly higher rate of heart and brain blood vessel problems occurred in patients being treated with Xolair compared to those patients not treated with Xolair. The heart and brain blood vessel problems included mini-strokes known as transient ischemic attacks or TIAs; heart attacks; sudden, unexpected chest pain; high blood pressure in the arteries of the lungs called pulmonary hypertension; and blood clots in the lungs and veins. Although the data are suggestive of a serious safety signal, due to weaknesses in how the safety study was designed and carried out, we are unable to definitively confirm or determine the exact increased level of these risks with Xolair.
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It was back in July 2009, when the FDA issued its Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair), that the agency first started reviewing interim safety findings from a study of the asthma drug omalizumab (Xolair) which suggested that the medication may be associated with increased risk for ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and thromboembolic and thrombophlebitic events.
We reported on that earlier development in this September 2009 post, "Asthma Drug Xolair Is Being Investigated By FDA For Possible Cardiac Problems".
Returning to the September 2014 FDA Drug Safety Communication about Xolair, there is also discussion in that item about a cancer as a possible side effect:
Some previous clinical trials have shown slightly higher rates of various cancers in patients treated with Xolair compared with non-Xolair-treated patients. Our review of the 5-year safety study found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated with Xolair. However, due to limitations in the 5-year study, we cannot rule out a potential risk of cancer with Xolair, so we have added this information to the Warnings and Precautions section of the drug label.
We will continue to monitor the safety profile of Xolair and report significant developments here.