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Safety of Xolair is Being Tested by Manufacturer

By Oguz Ozdemir

Xolair (omalizumab) is a medication that is used by adults and children over the age of 12 who suffer from moderate and severe asthma. On July 16, 2009, the Food and Drug Administration (FDA) reported that it is reviewing the safety of Xolair based on a study by the manufacturer that it can cause heart problems.

Xolair is used by adults and children 12 years old and above who have asthma that has not been controlled through the use of inhalers that contain coricosteroids. The heart problems that have been reported from the use of Xolair are arrhythmia, cardiomyopathy, ischemic heart disease and cardiac failure. Other side effects include pulmonary hypertension, cerebrovascular disorders such as strokes, and embolisms.

The safety of this medication is being conducted in a study by the manufacturers of Xolair, Genentech. The study is entitled EXCELS – Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma. The purpose of the study is to monitor the long range safety of the drug by asthma users over a five year period.

The study encompasses 5,000 patients who will be treated with Xolair and a control group of around 2,500 patients who will not be treated with Xolair. In preliminary testing there has been data that has shown an increase in heart problems in patients using Xolair to control their asthma as opposed to the control group who did not receive the drug.

The FDA has only issued an Early Communication at this point and is not calling for any type of recall at this time. They also are not asking anyone who currently takes Xolair to discontinue using it until all of the facts from the study are available.

Earlier last month, the FDA did require the company to add a black box warning to its label stating that the use of Xolair could cause anaphylaxis, a severe allergic reaction that moves very rapidly and could result in death.

If you suffer from asthma and are susceptible to allergies you may want to consider another medication other than Xolair. And if you are a regular user of Xolair and have experienced any of the conditions listed above you should consult your physician and discuss a different course of action in dealing with your asthma.

The results of the EXCELS study will not be available until 2012. If you already have heart conditions or are at risk for hypertension, stroke or embolisms you should consider taking another form of medication other than Xolair to treat your asthma.

Our law firm, Napoli Bern Ripka LLP, has helped so many people who have become victims of recalled FDA medications. Don't wait to be a statistic as the pharmaceutical companies take years to confirm the safety or dangers of the medications that they manufacture. If you have suffered from the effects of any prescribed medications take the time to speak with any of our lawyers who are well versed on the effects of FDA drugs. The consultation is free; just call 1-888-LAW-IN-NY.

Originally posted at InjuryBoard by Oguz Ozdemir

Full post as published by New York City Personal Injury Lawyer on August 13, 2009 (boomark / email).