Xolair
Other serious Xolair Side Effects | What to Do if You Are Harmed by Xolair
The FDA has ordered
the addition of a black box warning to the anti-asthma
drug Xolair due to the risk of serious life-threatening
Xolair side effects. The most serious side effect of
Xolair is anaphylaxis, or severe allergic reaction to
the drug.
The FDA warns that Xolair can cause this
life-threatening anaphylactic reaction at any dose of
the medication and even if a patient previously used the
drug with no adverse reaction. There is also the risk of
delayed reaction to the drug, occurring two to
twenty-four hours following a Xolair dose.
Patients suffering from the Xolair side effect of
anaphylaxis often require immediate medical treatment,
which frequently requires self-administered to avoid
more serious injury. Nearly one in five patients will
require hospitalization because of Xolair anaphylaxis.
While this serious Xolair side effect is
life-threatening, the FDA has not received any reports
of fatal Xolair side effects.
If you or a loved one has suffered a serious allergic
reaction to Xolair, you may wish to confer with a legal
expert who can determine your eligibility for
compensation for medical expenses, pain and suffering,
and more. Please contact our offices for a confidential
free consultation with an experienced Xolair attorney
and learn more about your legal rights and options to
file a Xolair lawsuit.
What is Xolair?
Xolair (omalizumab) is an expensive injectable
prescription drug sold by Genentech, Inc. The FDA
approved Xolair in June 2003 for use in patients 12 and
older. Xolair is used to treat patients with moderate to
severe persistent asthma related to allergies caused by
perennial aeroallergens, such as grass, dust, and
pollen.
Xolair is also prescribed for off-label treatment of
allergic rhinitis. Xolair is a secondary treatment
intended for patients in whom corticosteroid treatments
have not been successful. Xolair has shown to decrease
the frequency of worsening asthmatic episodes.
The risk of Xolair side effect anaphylaxis has been
known since before the drug was approved by the FDA. In
pre-marketing clinical trials, Xolair was found to cause
serious anaphylaxis in one out of every 1,000 patients.
Despite this risk, Xolair was allowed on the market with
some warnings.
Due to numerous post-marketing reports of Xolair side
effect risks, the FDA has ordered that additional
warnings be included on Xolair and that Genentech
provide a Medication Guide to all patients, warning them
of these Xolair risks.
The Xolair Black Box Warning
In February 2007, the FDA ordered the addition of a
Xolair black box warning to all product packaging for
this asthma treatment. A black box warning is the most
serious caution the FDA can order short of pulling a
medication off the shelves.
The FDA decided to order this additional Xolair warning
because of the nature of the anaphylaxis reports the
agency had received since the drug was approved,
including the risk of fatal Xolair reactions, the
frequency of Xolair side effects, and the risk of a
delayed onset of adverse reaction to Xolair.
Xolair Side Effect Risks
Xolair can cause a serious allergic reaction called
anaphylaxis. The following are the most common symptoms
of anaphylaxis:
- Trouble breathing caused by a narrowing of the airways
(bronchospasm)
- Chest tightness
- Itching
- Hives/Rash
- Swelling of the tongue or throat
- Dizziness
- Fainting
- A drop in blood pressure
Between June 2003 and December 2005, the FDA received 48
reports of anaphylaxis caused by Xolair. Of these
patients, at least seven required hospitalization
because of the severity of their Xolair adverse
reaction.
The FDA also reports that Xolair anaphylaxis can occur
long after the medication is administered. For example,
a person may suffer a serious reaction to Xolair two to
24 hours after receiving the injection.
Additionally, the FDA states that an adverse Xolair
reaction can happen after the administration of any
dose. Patients who have taken Xolair in the past with no
adverse reactions are still at risk for suffering the
Xolair side effect anaphylaxis.
Expert Advice about Xolair
The FDA is now advising all doctors who administer
Xolair to take the following precautions:
• Observe all patients for at least two hours following
the administration of Xolair.
• In this time period, be prepared to manage
life-threatening allergic reactions, should they
develop.
The FDA also urges patients to be aware of the signs and
symptoms of anaphylaxis. Patients should also care and
know how to use emergency self-treatment, should this
adverse Xolair reaction occur. Patients are advised to
carry an epinephrine auto-injection called EpiPen.
Other serious Xolair Side Effects
Research also shows that Xolair may increase the risk of
certain cancers, such as breast cancer, prostate cancer,
and skin cancer.
What to Do if You Are Harmed by Xolair
If you or a loved one has been harmed by Xolair, you may
be able to seek compensation for your losses and
suffering. To protect your legal rights, it is important
to speak with a qualified Xolair lawyer as soon as
possible. Our experienced Xolair attorneys are prepared
to evaluate your case and determine the best way to help
you and your family seek the compensation to which you
are entitled.
Oshman & Mirisola can help you make informed decisions about your legal rights, so please call the Xolair attorneys at Oshman & Mirisola at Toll Free: 1(800)-400-8182 for your free legal consultation.
