FDA mandates stronger warning on asthma drug xolair

The U.S. Food and Drug Administration has told the manufacturer of an injected asthma drug to add the strongest warning possible to the medication's label.

The new alert for Xolair (omalizumab), marketed by Genentech Inc., draws attention to anaphylaxis as a potential side effect of the medication.

Anaphylaxis is a sudden, potentially life-threatening allergic reaction that can include trouble breathing, tightness in the chest, dizziness, fainting, itching and hives and swelling of the mouth and throat

The FDA has also asked Genentech to update the existing label warning and to provide a Patient Medication Guide with a strengthened warning for anaphylaxis.

Experts did not think the action would affect prescribing patterns greatly, however.
"It is probably going to affect prescribing in a very minor way," said Dr. Andrew Colin, director of pediatric pulmonology at the University of Miami Miller School of Medicine. "This cannot be viewed as a routine medication at this point in time. It's reserved for the severe or resistant patient, so I do not think that these extra precautions are really going to have a huge impact."
"It's still a valuable drug and, like any drug, people can become allergic and have anaphylaxis," added Dr. Len Horovitz, a pulmonary specialist with Lenox Hill Hospital in New York City. "That's not really a shock here."

Xolair was approved in 2003 to treat adults and adolescents 12 years and older with moderate to severe persistent allergic asthma whose symptoms can't be fully controlled with inhaled steroids.

Some 17 million American adults and children suffer from asthma, 60 percent of them from allergic asthma.
According to one study, adding Xolair to a patient's medication regimen helps cut emergency medical visits. It also decreases the rate of asthma exacerbations.
Persistent asthma (as opposed to intermittent asthma) carries a high risk of exacerbations and the need for resultant medical treatment.

In some people, asthma is caused by an allergic reaction gone awry: The immune system stimulates the production of IgE antibodies. Subsequent exposure to the allergen or allergens causes the IgE antibodies to set off an inflammatory response, which leads to the wheezing and other breathing difficulties associated with asthma.

Xolair is a monoclonal antibody that interrupts this potentially life-threatening process at the start. It is the first biologic approved for asthma, and is given by injection once a month.
The drug already has a black box warning for a possible raised risk for malignancies, although that link is not definite, Horovitz said.

Source: www.epsdrugstore.com