FDA Cautions on COPD Inhaler and Stroke Risk
The U.S. Food and Drug Administration cautioned Tuesday that a respiratory inhaler used for chronic obstructive pulmonary disease may heighten the risk for stroke.
The agency said that German drug maker Boehringer Ingelheim, which manufactures Spiriva HandiHaler, reported that ongoing safety monitoring identified a possible increased risk of stroke in patients who take the medicine.
The inhaler contains tiotropium bromide and is used to treat bronchospasm associated with COPD, the FDA said in a prepared statement, adding that additional information is needed to further evaluate this preliminary information.
Boehringer Ingelheim reported that it has conducted an analysis of the safety data from 29 placebo-controlled clinical studies involving 13,500 patients with COPD, the FDA said. In 25 of the clinical studies, patients were treated with Spiriva HandiHaler, which is a once-daily, long-term maintenance medicine. In the other four, patients were treated with another formulation of tiotropium approved in Europe, Spiriva Respimat.
Based on data from these studies, the FDA statement said, the preliminary estimates of the risk of stroke were eight patients per 1,000 patients treated for one year with Spiriva, and six patients per 1,000 patients treated for one year with a placebo. That translates to an estimated excess risk of any type of stroke due to Spiriva to two patients for each 1,000 patients using Spiriva over a one-year period.
The FDA said it was working with the drug maker to evaluate the potential link, and it cautioned patients using Spiriva to not stop using the medication without talking to their doctors.
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Stress Common Among U.S. College Students: Survey
Stress is a major problem for many U.S. college students, according to a survey that included 2,253 undergraduate students, ages 18-24, at 40 schools nationwide.
Four in 10 students said they were stressed often, nearly 20 percent said they felt stress all the time, one in five said they had felt too stressed to be with friends or do homework, and about the same number said things had been so bad in the past three months that they had given serious consideration to dropping out of school, the survey found.
The poll was conducted for the Associated Press and mtvU, a television network available at many colleges and universities.
Among the other findings:
- Many students said they had symptoms such as: difficulty concentrating, sleeping and being motivated; agitation; worry; being too tired to work; eating problems; and feeling lonely and depressed.
- About one in six said they had friends in the past year who had discussed committing suicide, and about one in 10 respondents said they had seriously considered suicide themselves.
- Primary sources of stress included school work and grades, financial problems, relationships and dating, family problems, and extracurricular activities.
- Women were more likely than men to feel stressed -- 45 percent vs. 34 percent.
- White students reported more stress than black and Hispanic students.
- About 26 percent of students said they considered talking to a counselor or getting other professional help, but only 15 percent said they actually did so.
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U.N. Agency Warns of Indonesian Bird Flu Crisis
The "critical" H5N1 bird flu situation in Indonesia could lead to a virus mutation that could trigger a human pandemic, the U.N.'s Food and Agriculture Organization warned Tuesday.
The prevalence of the H5N1 strain of bird flu remains serious, despite national and international efforts to contain it. Joseph Domenech, the U.N. agency's chief veterinary officer, said he's "deeply concerned that the high level of virus circulation in birds in the country could create conditions for the virus to mutate and to finally cause a human influenza pandemic," Agence France-Presse reported.
He noted that the virus is present in nearly all areas of Indonesia, which has reported a total of 105 human deaths from bird flu, including 11 this year.
To date, most human cases of bird flu in Indonesia and other affected countries have been the result of close contact with infected poultry. However, experts fear that H5N1 may mutate into a form that's easily transmitted between people.
Domenech said the human death rate "from bird flu in Indonesia is the highest in the world, and there will be more human cases if we do not focus more on containing the disease at the source in animals," AFP reported.
New H5N1 variants have recently emerged, "creating the possibility that vaccines currently in use may not be fully protecting poultry against the disease," Domenech said.
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Progress Against TB Slowing: WHO
Progress against the global tuberculosis epidemic may be slowing, a World Health Organization report suggests.
The report, released Monday, found that the rate of new cases fell by less than 1 percent between 2005 and 2006, far less than the targeted annual decrease of 5 to 7 percent, the Associated Press reported.
The WHO report, based on government data from 202 countries and regions, said there were an estimated 9.2 million new TB cases and 1.5 million TB deaths worldwide in 2006. Countries with the most TB cases were India, China, Indonesia, South Africa and Nigeria. By region, Asia (55 percent) and Africa (31 percent) had the majority of TB cases.
The WHO said TB infection rates decreased about 3 percent in the United States and were stable in Europe, the AP reported.
Outdated drugs, obsolete diagnostic tests, overburdened health systems, and a lack of vaccines are among the factors contributing to the slowdown in the fight against TB, Dr. Marcos Espinal, executive secretary of the WHO's Stop TB Partnership, told the AP.
Some health experts say the WHO's TB policy is too passive and the organization needs a more proactive strategy to combat the disease.
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Vegan Diet May Reduce Heart Disease Risk in Arthritis Patients
A vegan diet may help reduce the increased risk of heart attack and stroke in people with rheumatoid arthritis (RA), says a Swedish study.
RA causes inflammation that affects arteries; heart attack and stroke are among the leading causes of death among people with RA. The new study found that RA patients who ate a vegan diet had lower levels of "bad" LDL cholesterol, a major heart disease risk factor, BBC News reported.
The study by researchers at the Karolinska Institute in Stockholm included 38 people who ate a vegan diet that included nuts, sunflower seeds, fruits and vegetables, millet, corn and sesame milk. The diet led to a decrease in total cholesterol levels and a reduction in the amount of LDL cholesterol. The volunteers on the diet also had a lower body mass index at the end of the 12-month study.
The findings were published in the journal Arthritis Research and Therapy.
The new research is interesting, but should be considered with caution, a spokeswoman for the Arthritis Research Campaign told BBC News. "A vegan diet may be helpful in reducing cholesterol, but it is difficult to get enough of some important nutrients on a vegan diet," she said.
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ADHD May Increase Girls' Risk of Eating Disorders
Teen girls with attention deficit hyperactivity disorder (ADHD) may have a significantly increased risk of developing eating disorders, says a University of Virginia study that included 140 girls with ADHD and 88 girls without the disorder.
The researchers found that some of the girls with ADHD were 5 percent to 10 percent more likely to show signs of an eating disorder than girls without ADHD, CBC News reported.
"Girls with ADHD may be more at risk of developing eating disorders as adolescents because they already have impulsive behaviors that can set them apart from their peers," study lead author Amori Yee Mikami said in a prepared statement. "As they get older, their impulsivity may make it difficult for them to maintain healthy eating and a healthy weight, resulting in self-consciousness about their body image and the binging and purging symptoms."
The study, published in the Journal of Abnormal Psychology, also found that girls with ADHD were more likely to have received critical parenting when they were younger, had more difficulty relating to peers, and were more likely to be overweight, CBC News reported.
ADHD affects about 5 percent of school-age children, the researchers said.
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Children With Allergies Less Active Than Peers: Survey
Many American children with allergies aren't getting the treatment they need, and children with allergies are less active and productive than their peers, according to survey presented Monday at the annual meeting of the American Academy of Allergy, Asthma and Immunology.
The survey included more than 500 parents of children with allergic rhinitis and a similar number of parents of children without allergies. Among the findings:
- About 76 percent of parents said spring was the worst time of year for their children's nasal allergies.
- Forty percent of parents said their children's allergies interfered with sleep, compared to eight percent of parents of children without allergies.
- Twenty-one percent of parents said allergies limited their children's activities, compared with 11 percent of parents of children without allergies.
- Forty percent of parents of children with allergies said the condition interfered with school performance. Only 10 percent of parents of children without allergies said health issues caused poorer school performance.
- The most bothersome symptom for children with allergic rhinitis is a stuffed up nose (27 percent), but about 46 percent of parents said their children also suffered more serious symptoms, such as headache and ear and facial pain.
- About 48 percent of allergic children in the survey are currently taking prescription drugs to treat symptoms. Of those, 57 percent have had their medication switched. Ineffective allergy control was the leading reason for changing medications.
- Bothersome side effects -- such as products dripping down the throat, bad taste, burning, and headache -- were among the reasons for dissatisfaction with allergy medications.
The Pediatric Allergies in America survey was released by Sepracor Inc, a manufacturer and distributor of respiratory pharmaceutical products.
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