FDA Approves New Nasal Spray for Hay Fever
The nasal spray Omnaris (ciclesonide) has been approved for treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis -- better known as hay fever -- in adults and children 12 years of age and older, the U.S. Food and Drug Administration announced Monday.
The new drug is a corticosteroid, which are hormone-like drugs that suppress the body's immune response. The precise way Omnaris works is unknown, the FDA said.
The approval was based on the results of four clinical trials ranging in length from two weeks to a year. The trials found that patients who used Omnaris had 8 percent to 10 percent fewer hay fever symptoms than patients who used a placebo.
The most common side effects caused by the drug included headache, nosebleeds, and inflammation of the nose and throat linings, the FDA said.
Omnaris is made by Altana Pharma U.S. of Florham Park, N.J.
About 35 million Americans suffer from allergic rhinitis.
Drug Approved to Treat Both Sides of Bipolar Disorder
A new formulation of the schizophrenia drug Seroquel has been approved in the United States for the treatment of both manic and depressive episodes of bipolar disorders, making it the first drug of its kind, the Associated Press reported.
Serouquel was previously approved in the United States to treat acute manic episodes associated with schizophrenia and bipolar disorder. The new FDA approval, announced Monday, allows the drug to also be used to treat depressive episodes.
Drug maker AstraZeneca PLC has applied for similar approvals in Canada and the European Union, the AP reported.
Monday's FDA approval was based on the results of an eight-week study of 1,045 patients with bipolar disorder. The study found that patients who took the drug had greater improvement in bipolar depression symptoms, overall quality of life, and satisfaction related to functioning than patients who took a placebo, according to AstraZeneca.
The new Seroquel formulation uses a once-daily dose, while the current immediate-release tablets are approved for dosing two to three times a day, the AP reported.
Seroquel was introduced in 1997 and is one of the company's top selling drugs, with total sales of $2.8 billion last year. About seven million American adults have bipolar disorder.
Rare Genetic Disorder Linked to Lung Disease Risk
People with a rare genetic disorder called alpha-1 antitrypsin (A1AT) deficiency may be predisposed to developing lung disease and this could help explain the rapid decline in lung function among some World Trade Center (WTC) rescue workers, says a U.S. study.
Researchers tracked 90 rescue workers from October 2001 through 2005 and found that the 11 workers who were moderately or severely deficient in the A1AT protein experienced faster lung decline than other workers.
A1AT deficiency changes the ability of the lungs and liver to control the naturally occurring healing process, resulting in unchecked inflammation in those organs, the study authors said.
"Some with the defect will develop emphysema early, even without cigarette smoking. Others... may need to be exposed to additional environmental irritants in order to develop emphysema and other forms of obstructive airway disease," lead author Dr. Gisela Banauch, of Montefiore Medical Center in New York City, said in a prepared statement.
The findings were presented Monday at the annual scientific meeting of the American College of Chest Physicians.
The study authors also said that a new rapid-response test could help identify patients with A1AT deficiency before they suffer significant lung damage.
Study Trims 'Freshman 15'
The term "Freshman 15" doesn't carry as much weight as previously believed.
It's been used to described how many extra pounds, on average, U.S. college students put on during their first year away from home -- the result of unlimited and unsupervised food choices. But new research suggests the weight gain is more like eight pounds or less, USA Today reported.
Researchers at Brown University Medical School studied data on 382 Brown students and 907 students at Purdue University. They found that male and female students at Purdue gained an average of 7.8 pounds during their freshmen year. Most of that weight was added in the first semester. The weight gain by the end of the sophomore year was 9.5 pounds for males and 9.2 for females.
The study also found that male students at Brown gained an average of 5.6 pounds during their freshman year, and female students gained an average of 3.6 pounds, USA Today reported.
The findings were released at the Obesity Society's annual meeting in Boston.
Even though first-year college students don't pack on as much weight as previously thought, nutritionists say there is still cause for concern.
"While most are not gaining the Freshman 15, many are gaining weight and aren't taking it off," lead researcher Elizabeth Lloyd-Richardson, assistant professor of psychiatry and human behavior at Brown told USA TODAY.
No Link Between Deaths, Flu Shots: Israeli Official
So far, investigators have found "no connection" between influenza vaccinations and the deaths of four people in Israel, says Health Minister Ya'acov Ben-Yizri.
However, the flu shots have been halted and will not resume until completion of the investigation, the Jerusalem Post reported.
All four victims -- ages 52, 67, 70 and 75 -- died from heart problems between one and five days after they received the flu vaccine, supplied by the Pasteur Institute of France. All the victims had existing health problems.
Three of them were residents of Kiryat Gat and were vaccinated at the same Kupat Holim Leumit clinic. The fourth victim received his flu shot at the Kupat Holim Meuhedet clinic in the city of Petah Tikva, the Post reported.
Over the past few weeks, more than 140,000 Israelis have received the flu vaccine. Due to a worldwide temporary shortage of flu vaccine, flu shots in Israel have been limited to people considered to be at high or very high risk of complications from the flu, such as pneumonia.
Government officials are worried that news of the deaths will discourage other people at high risk for flu complications -- the elderly, children ages six months to two years, and anyone with chronic disease or weak immune system -- from getting vaccinated once the flu shot program resumes.
Older Women Capable Mothers: Study
Women 50 and older who have babies are physically and mentally as "capable" as younger mothers, says a University of Southern California study presented at the annual meeting of the American Society for Reproductive Medicine.
The study of 150 women in their 30s, 40s, and 50s concluded that older mothers did not have higher stress levels or health risks than younger mothers, BBC News reported.
The findings suggest that criticism of women who have babies at an older age is based on prejudice rather than any evidence that they're less capable mothers than younger women, and that there is no reason to bar older women from having in-vitro fertilization, said researcher Anne Steiner.
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