BETHESDA, MD -- February 21, 2007 -- FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair. Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis-with onset two to 24 hours or even longer-after receiving Xolair treatment. Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose. Health care professionals who administer Xolair should be prepared to manage life-threatening anaphylaxis and should observe their Xolair-treated patients for at least two hours after Xolair is given. Patients under treatment with Xolair should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following Xolair treatment, and how to treat it when it occurs. FDA has requested Genentech add a boxed warning to the product label and to revise the label and provide a Medication Guide for patients. SOURCE: Food and Drug Administration
Use of Most Asthma Drugs During Pregnancy Does Not Change Birth Outcomes
WESTPORT, CT (Reuters Health) Jun 29 - Pregnant women who receive prescriptions for most commonly used asthma medications are no more likely than their counterparts to produce offspring with decreased gestational age, birth weight, or length at birth, according to data from a population-based study in Denmark.
Dr. Charlotte Oleson of the University of Aarhus and associates linked data from several registries to identify 15,756 primiparous women who gave birth to singleton infants between 1991 and 1996. Of these, 303 had received at least one prescription for an asthma drug during their pregnancy.
Prescriptions for inhaled and systemic ß-agonists and inhaled steroids were not associated with birth outcomes, the investigators report in the May/June issue of Respiration. However, offspring of the 24 women who received a prescription for theophyllamine or systemic steroid were more likely to be of low birth weight and small for gestational age compared with the reference group.
There were two infants born with a malformation — clubfoot or pyloric stenosis — among the 11 women who used theophyllamine from 30 days prior to conception until 8 weeks of gestation. These could be "due to a drug effect, confounding, or chance," the authors write.
The 78 women who decreased asthma medication during pregnancy gave birth to infants with lower mean gestational age, birth weight, and length at birth than infants born to the rest of the women in the cohort. According to Dr. Oleson's group, this finding may indicate that these women stopped therapy even though their asthma severity justified continuation.
"Although authorities have argued that the risks of uncontrolled asthma appear to be higher than the risk of recommended drugs, the information on many drugs includes nonspecific warnings that may lead to a too-conservative drug use during pregnancy," the investigators conclude.
Acid Reflux Therapy May Cut Kids' Asthma Drug Usage
Previous studies in adults have suggested that as many as 4 out of 5 asthmatics experience the chronic cough and hoarseness of acid reflux, a condition triggered by the regurgitation of stomach acid into the esophagus. While the connections between asthma and GERD remain unclear, researchers have noticed that antireflux medications can sometimes help asthma symptoms.
In the current study, lead author Dr. Vikram Khoshoo and colleagues at the West Jefferson Medical Center in New Orleans, Louisiana, evaluated asthma medication usage among 27 children diagnosed with persistent moderate asthma and GERD. The group was compared to 19 other children (the control group) with asthma but no symptoms of GERD.
Eighteen of the youngsters with both asthma and GERD received drugs, including prescription heartburn relievers known as proton pump inhibitors (PPIs), and 9 underwent surgical treatment for GERD.
One year later, all of the patients who got some kind of anti-GERD treatment -- medication or surgery -- were able to reduce their asthma medication by more than 50 percent, according to the study published in the journal Chest.
Among the children in the control group, 2 of 8 children with asthma but not GERD who took anti-GERD medication reduced their asthma medication usage, while the other 11 children, who took no such medication, did not reduce their asthma medication usage, the study indicates.
"Children with persistent asthma often take the maximum amount of medications to maintain their asthma, yet they still end up in the emergency room on a regular basis," said Khoshoo in a prepared statement.
"With anti-GERD treatments such as PPIs, we may be able to help to lighten our patients' asthma regimens and eventually reduce the number of emergency room visits and school days missed," the researcher added.
SOURCE: Chest 2003;123:1008-1013.
Xolair Controls Worst Asthma -Study
LONDON (Reuters) - Novartis AG's asthma medication Xolair effectively controlled even very severe cases of asthma, according to results of a clinical a study released on Monday.
he new data will be used by the Swiss healthcare group to strengthen its case with European regulators for the drug to be approved as a treatment for people with uncontrolled, and sometimes life-threatening, asthma.
A 419-patient study presented at the annual meeting of the European Respiratory Society in Glasgow showed Xolair reduced the rate of clinically significant asthma attacks by 26 percent during 28 weeks of treatment.
Xolair, the first biotechnology treatment for asthma, was developed by Novartis, U.S. biotechnology group Genentech and Tanox Inc and was approved in the United States last year. It was filed for EU approval in July.
It works by disabling a naturally occurring antibody called IgE that triggers the release of chemicals that cause inflammation.
Xolair treats the underlying cause of asthma triggered by allergies rather than the symptoms that inhaled corticosteroids address. However, it is less convenient then inhalers because the drug has to be injected.
In the United States, it is approved for treating moderate to severe asthma but Novartis seeking approval in Europe for a narrower use among patients worst affected by asthma.
Around 300 million people in the world have asthma, of whom an estimated 15 million have severe or life-threatening forms of the disease.
Xolair generated U.S. sales of $30 million in the first quarter this year after U.S. sales came in at $25.3 million for the full-year.
U.S. regulators approved the drug last year and said Xolair's benefits in preventing asthma outweighed its risks, which U.S. Food and Drugs Administration staff said could include a higher cancer risk.
In studies, 0.5 percent of Xolair-treated patients developed cancer, compared with 0.2 percent of patients given a placebo, but there was no direct evidence linking the malignancies to the drug.
new anti-IgE treatments take an entirely different approach, working to help prevent the body from reacting to an allergen in the first place.
"An anti-IgE binds to IgE and ties it up, preventing it from activating and inflaming the mast cells," Rosenwasser says.
The body is "tricked" into believing there is no allergen present. So, it responds as if there were no allergy.
More importantly, anti-IgEs are not "allergen-specific." Theoretically, they can work to block almost any type of allergic reaction.
"It has promise in all allergic diseases," says Rosenwasser, "including drug and food allergies."
The good news is that the first anti-IgE medication -- a drug known as Xolair (omalizumab-RhuMAb-E25), manufactured by Genetech -- is expected to be approved by the U.S. Food and Drug Administration (news - web sites) in time for the spring-summer allergy season.
The discouraging news is that it must be administered by your doctor, via injection, once or twice a month, which is expected to be costly. And since it was tested primarily in asthma patients, it's true effectiveness with seasonal allergies has not yet been fully determined.
Statins Reduce Severe Asthma Attacks
Patients on corticosteroids are one-third less likely to need emergency room treatment or hospitalization when also taking statin medications
Study is first in a series to examine factors impacting patient response to asthma medications
FRANKLIN LAKES, N.J., March 14 /PRNewswire-FirstCall/ -- Results of a new study presented at the 2009 Annual Meeting of the American Academy of asthma, Allergy and Immunology (AAAAI) show dramatic reductions in emergency room (ER) visits and hospitalizations for asthma patients taking cholesterol-lowering statins in addition to common asthma treatments. The study was jointly conducted by researchers from Medco Health Solutions, Inc. (NYSE: MHS) and Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School.
In the first and largest investigation of statin effects on clinical outcomes in humans with asthma, researchers found that among adult patients on inhaled corticosteroids, those also taking statins reduced their odds of an asthma-related hospitalization or ER visit by 33 percent.
"The implications of this study are exciting because they point to the potential role statins could play in helping prevent the most serious asthma attacks that land patients in the hospital," said Dr. Robert Epstein, Medco's chief medical officer and one of the study authors. "There has been heightened interest in how the anti-inflammatory power of statins might benefit asthma patients and a number of animal studies have shown encouraging results. While the findings of this patient study should be considered preliminary and further clinical studies will be needed to draw any conclusions about care, they do show promise for the use of statins in asthma treatment. To that end, there are currently a number of prospective studies on this topic underway that