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Xolair® (omalizumab)

Xolair is an asthma drug that is manufactured and marketed by Genentech and Novartis, respectively, and it hit the market with a high degree of promise. It is currently being used by 30,000 to 35,000 patients, and is administered by injection into the patient every other week. Several issues have arisen in regards to Xolair including an increased number of heart attacks and strokes.

Why is Xolair prescribed?

Xolair is used by patients who suffer from allergic asthma, and is most prominently prescribed for patients who continue to have asthma symptoms despite their ongoing use of inhaled steroids. Inhaled steroids have been the medication of choice for many years for those who want to mitigate their symptoms, but one of the reasons that Xolair exists is because not everyone is able to minimize them with “traditional” medications.

Xolair works in a scientific sense by capturing a molecule known as IgE. Researchers have discovered that this is the molecule in your body that can be one of those most responsible for the initiation and continuation of asthma attacks. Xolair “traps” IgE, and as a result it helps to stop asthma attacks and symptoms before the patient feels them.

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What are the FDA approved uses for Xolair?

Xolair was originally approved by the FDA in 2003, but part of the approval process required a post-approval study that was set to run between 2004 and 2012. This post-approval study is quite standard operating procedure for the FDA, and while it is currently legal to market, sell and distribute Xolair, the results of this post-approval study could change that status.

Although no action has yet been taken to change this status, the early indications from the study are prompting the FDA to announce that it is conducting a safety review of Xolair. The FDA has stated that as of now, it would not require any change in status in terms of the prescription regulations it must follow.

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What are the side effects of Xolair?

The study at issue has reported preliminary statistics that show that those who have been using Xolair have suffered an increased number of heart attacks and strokes. While no information has yet been offered as to the root cause of this issue, one of the conclusions that the safety review is likely looking to come to involves the answer to that question.

The FDA has offered its own statement as to why this safety review is being initiated: [the data] “suggest a disproportionate increase in ischemic heart disease, arrhythmias … cardiac failure” and other conditions “in patients treated with Xolair compared to the control group of patients not given the drug,” the agency said.

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Xolair warnings and alerts

There have been previous reports of side effects for those patients who have used Xolair, but none have been prevalent enough to prompt the action described above. However, in 2007, the FDA ordered that the manufacturers place a ‘Black Box Warning’ on all labels of Xolair because of its link to one side effect that has proven to be extremely dangerous and potentially deadly. This side effect is known as anaphylaxis, and 48 incident reports of this type prompted the warning order. Symptoms of anaphylaxis include:

  • Decrease in blood pressure
  • Hives
  • Narrowing of air passages
  • Vomiting
  • Diarrhea
  • Breathing difficulties
  • Swelling of the tongue
  • Swelling of the throat
  • Loss of consciousness

Generally, this condition developed quickly after an injection, and many patients began to feel the effects of anaphylaxis within two hours and many others within 24 hours of the injection of Xolair. As part of the warning issued in 2007, the FDA asked doctors who were administering Xolair to observe their patients for at least two hours before releasing them. Given the serious nature of the symptoms involved, anaphylaxis can be a fatal condition.

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Xolair drug contradictions

While no known contraindications have yet been published, those who have experienced a reaction to Xolair should seek another outlet for treatment. Otherwise, anyone who fits the following criteria:

  • Patients younger than 12
  • Elderly patients
  • Pregnant or breastfeeding patients

Have been found to be at risk if using Xolair.

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Xolair FAQs

How can Xolair be on the market if it’s causing dangerous side effects?

Several drugs remain on the market while they are being scrutinized. While the dangers could be present with its use, Xolair has shown itself to work for some patients. There is no hard-and-fast standard that dictates when a drug will be recalled – when its risks outweigh its benefits, it will no longer be available. Experts are still determining the answer to this equation with Xolair.

Should I stop using Xolair?

You should work with your doctor if you have concerns. Asthma is a dangerous condition, and simply stopping the medication could leave you vulnerable to more attacks. Speak with your doctor immediately if you are concerned that you could be at risk.

Can I file a lawsuit if I have suffered damages from taking Xolair?

Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

  • Past and future medical expenses
  • Past and future pain and suffering
  • Lost wages
  • Loss of future earning capacity
  • Emotional distress

If you or a loved one has experienced any health problems while taking Xolair, you should contact your doctor immediately. You may also wish to contact an experienced Xolair lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.

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