Asthma Drug Label Gets Anaphylaxis Warning
Labeling on the Genentech asthma medication Xolair (omalizumab) has been updated to include the U.S. Food and Drug Administration's strongest possible "black box" warning, advising doctors and consumers of the risk of anaphylaxis, the agency said Tuesday.
Anaphylaxis is a sudden, potentially life-threatening allergic reaction, with possible symptoms including trouble breathing, chest tightness, dizziness, fainting, itching, hives, and swelling of the mouth and throat.
Xolair, an injected medication, was approved in 2003 for people 12 years and older with moderate-to-severe persistent asthma that is inadequately controlled with inhaled corticosteroids.
In a statement, the FDA said it also ordered that a "new medication guide" warning of the anaphylaxis risks be distributed with each dose of Xolair.
Anaphylaxis has occurred in some Xolair users as early as the first dose, but it has occurred in others one year or more after the medication was begun, the agency said. Moreover, the reaction can occur more than 24 hours after administration of a dose.
The FDA, which ordered the warning earlier this year, recommended that Xolair only be administered in a healthcare setting under direct supervision by a medical professional who understands the drug's risks.
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Drug May Help Bad Memories Fade
A drug frequently used in heart patients can quash memories of a traumatic event, U.S. and Canadian researchers report.
The drug, a beta blocker called propranolol, was injected while study participants were asked to recall a traumatic memory from a decade earlier, BBC News reported. Nineteen participants involved in either a vehicle crash or sexual assault were injected with either the drug or a non-medicinal placebo for 10 days.
Those injected with propranolol, when asked to recall the event after completing the regimen, showed fewer signs of stress than those who didn't get the drug, the researchers said.
Experts not involved with the study cautioned that the research was preliminary, that post-traumatic stress was a complex condition, and that the long-term effects of the drug hadn't been evaluated, the BBC said.
Results of the study, by scientists at McGill University in Montreal and Harvard University in Boston, were published in the Journal of Psychiatric Research.
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Endometriosis Raises Cancer Risk: Study
Endometriosis, a painful condition in which womb tissue begins to grow abnormally elsewhere in the abdomen, may raise a woman's cancer risk, new research finds.
Women with endometriosis have a greater chance of contracting many types of cancer, including those of the ovaries, kidneys, hormonal glands, brain, skin and breasts, the Times of London reported of the Swedish study's conclusions.
Endometriosis causes lesions that often impair a woman's chances of becoming pregnant. And while female infertility has been shown in prior studies to raise a woman's risk of certain cancers, this study found that endometriosis itself may be linked to an increased cancer risk, study authors at Karolinska University Hospital in Stockholm said.
The scientists studied 63,000 women with endometriosis, finding they were 38 percent more likely to develop tumors of the hormonal glands, and were at higher risk of ovarian cancer (37 percent), kidney cancer (36 percent), thyroid cancer (33 percent), brain cancer (37 percent), skins cancer (23 percent), and breast cancer (8 percent) than women who didn't have endometriosis, the Times reported.
The research was released at a meeting of the European Society of Human Reproduction and Embryology in Lyon, France.
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Many With Food Allergies Ignore Warnings: Study
Some 12 million Americans are allergic to at least one type of food, and a growing number of them are ignoring advisory warnings that appear on food labels, the Food Allergy and Anaphylaxis Network (FAAN) said Monday.
The label warnings state that the product could unintentionally contain an allergen by virtue of being produced at a facility that makes other products that contain allergens, the FAAN said. So-called "advisory labeling" is unregulated and is voluntary, the network said.
In study results published in the July issue of the Journal of Allergy and Clinical Immunology, researchers said 75 percent of food allergy sufferers surveyed in 2006 heeded the advisory warnings, down from 85 percent in 2005. The study was conducted by the FAAN and the Jaffe Food Allergy Institute at Mount Sinai School of Medicine in New York City.
"We believe that allergic consumers are increasingly ignoring the advisory labeling because the warnings are now used so frequently that consumers assume they are not serious," said study co-author Dr. Scott Sicherer of the Jaffe Institute.
The researchers said the wording of these advisories made a significant difference. A warning stating "may contain [allergen]" was heeded by 88 percent of those surveyed, while only 65 percent heeded a warning stating "made in a facility that uses [allergen]," the FAAN said.
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New Medicare Task Force Fights Equipment Fraud
Medicare has established a "fraud strike force" to combat fraudulent suppliers of medical equipment including motorized wheelchairs, nebulizers, prosthetics and orthotic supplies, U.S. Health and Human Services Secretary Mike Leavitt announced Monday.
The two-year initiative, launched in South Florida and Southern California, has already led to charges being filed against 56 people in Florida, accused of fraudulently billing Medicare for more than $258 million, Leavitt said in a statement. The initiative involves federal, state and local investigators.
A similar operation last year in Los Angeles resulted in 770 suppliers having their Medicare billing privileges revoked, the statement said.
The Centers for Medicare and Medicaid Services hopes to expand the program nationwide, Leavitt added.
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