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| FDA Issues Early Communication for Chantix |
The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid to smoking cessation treatment. An Early Communication reflects FDA's current analysis of available data concerning these drugs and does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue.
FDA is evaluating postmarketing adverse event reports for Chantix (varenicline), a prescription medicine to help adults stop smoking.
Based on FDA's request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.
FDA's Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.
In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
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| Eating Your Greens Could Prove Life-Saving if a Heart Attack Strikes |
A diet rich in leafy vegetables may minimize the tissue damage caused by heart attacks, according to researchers at the Albert Einstein College of Medicine of Yeshiva University. Their findings, published in the November 12 Proceedings of the National Academy of Sciences Online Early Edition, suggest that the chemical nitrite, found in many vegetables, could be the secret ingredient in the heart-healthy Mediterranean diet.
"Recent studies show that administering nitrite to animals, either intravenously or orally, can greatly limit the damage caused by a heart attack and the stress to tissue that follows due to reperfusion-the return of blood to oxygen-starved heart muscle," says Dr. David Lefer, the study's senior author and professor of medicine and of pathology at Einstein. "We wondered if feeding animals much lower levels of nitrite and nitrate-equivalent to what people can readily obtain from their diets-could also provide protection from heart-attack injury."
Nitrite and its "chemical cousin" nitrate are important because of their role in producing nitric oxide gas. In 1986, researchers made the remarkable finding that nitric oxide-famous until then mainly as an air pollutant-is produced by cells lining healthy arteries and plays a crucial role in cardiovascular health by dilating arteries and aiding blood flow. Damage to the artery lining (in atherosclerosis, for example) impairs nitric oxide production and leads to cardiovascular disease and, ultimately, to heart attacks and strokes.
Researchers now have good evidence that hearts undergoing heart attacks have a "backup" pathway for making nitric oxide. Triggered by falling oxygen levels, enzymes in heart muscle convert nitrite stored there into nitric acid that can then help minimize tissue damage. Nitrite in the diet comes mainly from vegetables-celery, beets, and spinach, lettuce and other leafy types. Once consumed, nitrite exits the bloodstream and then accumulates and become stored in organs such as the heart, kidney and brain. But it wasn't clear whether boosting nitrite in the diet could actually translate into better protection from heart-attack damage.
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| FDA Wants Warnings On Flu Drugs For Kids |
Government health regulators recommended adding label precautions about neurological problems seen in children who have taken flu drugs made by Roche and GlaxoSmithKline.
The Food and Drug Administration on Friday released its safety review of Roche's Tamiflu and Glaxo's Relenza. FDA's panel of outside experts will consider the government's proposed labeling at its meeting Tuesday. FDA is not required to follow the advice of its outside experts, though it usually does.
FDA began reviewing Tamiflu's safety in 2005 after receiving reports of children experiencing neurological problems, including hallucinations and convulsions.
Twenty-five patients under age 21 have died while taking the drug, most of them in Japan. Five deaths resulted from children "falling from windows or balconies or running into traffic."
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| Saline Irrigation Eases Chronic Nasal Symptoms |
Saline irrigation is a safe, inexpensive and effective method for treating chronic nasal and sinus symptoms, according to a new study.
Researchers at the University of Michigan Health System also concluded that saline irrigation -- the flushing of nasal passages with a salt water mixture -- is more effective than commonly used saline sprays at providing short-term relief of chronic nasal symptoms.
The study included 121 adults with chronic nasal and sinus symptoms. Sixty were treated for eight weeks with saline irrigation, and 61 were treated with saline spray.
The patients in the saline irrigation group showed greater improvement at two, four and eight weeks.
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St. Jude Finds Molecule That Could Improve Cancer Vaccines and Therapy for Other Diseases
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Investigators at St. Jude Children's Research Hospital have discovered a new signaling molecule that prevents immune responses from running amok and damaging the body. The finding could lead to the development of new treatments for cancer, using vaccines; for autoimmune diseases, such as Type 1 diabetes; and for inflammatory diseases, such as inflammatory bowel disease (IBD) and asthma.
The St. Jude team discovered that specialized immune lymphocytes called regulatory T cells release a protein complex composed of two proteins called Ebi3 and Il12a. This protein complex acts like a brake on the activity of the aggressive immune cells called effector T lymphocytes. A report on this discovery appears in the journal Nature Nov. 22, 2007.
The newly recognized protein complex is one of a large group of signaling molecules called cytokines that cells use to communicate with each other. Since the immune system cytokines are called interleukins, the St. Jude team named this protein interleukin-35 (IL-35). Most cytokines stimulate immune system cells by driving the immune attack or causing inflammation. However, IL-35 is one of the few signaling molecules known to inhibit immune system activity.
"The discovery of IL-35 is important because the manipulation of regulatory T cells is a key goal of immunotherapy," said Dario Vignali, Ph.D., associate member in the St. Jude Department of Immunology, and the paper's senior author. Immunotherapy is the treatment of infections, cancer or other diseases by manipulating the immune system to enhance or restrict its activity. Despite the fact that regulatory T cell-mediated immunotherapy holds promise for patients, the molecules responsible for the cells' ability to suppress immune system activity are largely unknown, a problem that has slowed progress in this field.
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| The Hormone of Darkness: Melatonin Could Hurt Memory Formation at Night |
What do you do when a naturally occurring hormone in your body turns against you? What do you do when that same hormone - melatonin - is a popular supplement you take to help you sleep? A University of Houston professor and his team of researchers may have some answers.
Gregg W. Roman, assistant professor in the department of biology and biochemistry at UH, describes his team's findings in a paper titled "Melatonin Suppresses Nighttime Memory Formation in Zebrafish," appearing Nov. 16 in Science, the world's leading journal of original scientific research, global news and commentary.
Frequently called "the hormone of darkness," melatonin is a hormone the body produces that may regulate patterns of sleeping and awakening in humans. In almost all organisms tested, this antioxidant's natural levels are high during the night and low during the day. In addition to what the body produces naturally, many people also take melatonin supplements to fight jet lag, balance out seasonal affect disorder and regulate nighttime dementia.
Roman says, however, that melatonin could actually be hurting you at night, finding in a study with zebrafish (Danio rerio) that melatonin directly inhibits memory formation.
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| Drug Dosages Often Incorrect For Obese Patients |
As if severely overweight people didn't already have enough health concerns, experts are raising another red flag -- the possibility that some of their prescription medications, especially antibiotics, may not be prescribed at the appropriate dosage and could be ineffective.
Because most adult antibiotics are produced in a "one size fits all" dosage and some doctors are not attuned to this issue, the societal trend towards severe obesity is resulting in more individuals who get inappropriate drug therapies for infectious disease, a new study in the journal Pharmacotherapy suggests.
"The number of individuals with the highest body mass index, very obese people, is up 600 percent between 1986 and 2000," said David Bearden, a clinical associate professor in the College of Pharmacy at Oregon State University.
"Very obese individuals in some cases, even those with severe infections, may be getting only half the necessary dose of a prescription drug such as an antibiotic," Bearden said. "That's a problem. It could lead not only to antibiotic failure but also an increase in antibiotic resistance, another serious issue.
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Believe it or not
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Surgeons Remove Ten-Pound Hairball From Teen Girl's Stomach
Surgeons removed a massive 10-pound hairball from the stomach of an 18-year-old girl suffering from a psychological condition in which she ate her own hair, according to a report in this week's edition of the New England Journal of Medicine.
The teen went to her doctor after complaining of stomach pains and vomiting. She had also lost 40 pounds over a five-month period, according to a UPI report.
Doctors at Rush Medical Center in Chicago carried out a scan and were amazed to find the huge mass of hair blocking her entire stomach, according to NEJM.
The hairball measured 15 inches by 7 inches by 7 inches when it was removed.
Once the hairball was removed, the patient was discharged and given psychiatric help. A year later the teenager has gained 20 pounds and has stopped eating her hair, the journal said.
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News From MedWatch |
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