FDA approves LIALDA™ (mesalamine)
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Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and Drug Administration (FDA) has approved LIALDATM(mesalamine) with MMX® technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis. Shire will launch LIALDA in the U.S. in the first quarter of 2007.
Once-daily LIALDA with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day. A recent study conducted by the Crohn’s and Colitis Foundation of America (CCFA) found that 65 percent of patients with ulcerative colitis are poorly compliant with their medication, citing pill burden and inconvenience associated with the medication.
Risk of Stroke Expected to Decrease with New Screening Guidelines
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For the first time, a set of screening guidelines for the detection of carotid stenosis, the thickening of the blood vessel that supplies blood to the brain and a leading cause of stroke, has been developed by a multidisciplinary committee of internationally recognized neurologists and surgeons. These guidelines will help reduce the death and disability rates associated with stroke by identifying carotid stenosis in a timely manner, allowing treatment before a stroke occurs. These guidelines appear in the latest issue of Journal of Neuroimaging.
Aspirin may prevent asthma in adults: study
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Results from the Physicians Health Study indicate that regular use of aspirin may reduce the risk of “new-onset” asthma in adults by 22 percent.
However, there is no evidence that aspirin improves symptoms in people who already have asthma, and it may, of course, cause acute breathing difficulties among individuals with “aspirin-intolerant asthma.”
Prenatal infection may up leukemia risk in child
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A mother who contracts influenza, pneumonia, or a sexually transmitted disease around the time of pregnancy appears to be at increased risk of having a child that will develop leukemia, new research shows.
These observations “suggest that maternal infection might contribute to the develop of childhood leukemia, which has been postulated to have an infectious origin,” Dr. Marilyn L. Kwan, from the Division of Research at Kaiser Permanente in Oakland, California told Reuters Health.
Prenatal antidepressants seem not to affect child
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The use of antidepressant drugs during pregnancy does not appear to have a significant effect on the behavior of the child, Canadian and Korean researchers report in the Archives of Pediatrics and Adolescent Medicine.
Dr. Tim F. Oberlander of the University of British Columbia, Vancouver and colleagues compared behaviors of 22 children who were prenatally exposed to a selective serotonin uptake inhibitor (SSRI), one of a relatively new class of antidepressant drugs including Prozac and Zoloft, along with 14 unexposed children.
Counseling may cut risk of drinking in pregnancy
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Women who drink often and fail to use reliable birth control are at high risk of drinking during pregnancy. But a new study suggests that just a few counseling sessions can reduce those odds.
Researchers found that five brief counseling sessions helped high-risk women to both reduce their drinking and start using effective birth control.
Mortality risk higher for children of mentally ill
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A Danish population-based study suggests that the relative risk of death is statistically raised among children with one or two mentally ill parents, although the absolute risk is still low.
Principal investigator Roger T. Webb, research fellow at the University of Manchester Division of Psychiatry, UK, and colleagues analyzed the risk of death from any cause in children whose mother or father had been admitted for psychiatric treatment and compared them against mortality risks in the general population.
Schizophrenia drug helps anorexia patients
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The antipsychotic drug quetiapine may help ease symptoms in patients with anorexia nervosa, a small new study shows.
Nine of 19 anorexia patients in the study gained weight after 10 weeks on the drug, Dr. Pauline S. Powers and colleagues from the University of South Florida in Tampa report.
The secret women keep from themselves
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Do women have a secret so painful that they even keep it from themselves?
According to Dr. Anita H. Clayton of the University of Virginia Health System, the secret exists, and it’s big. In an era when so many women are over-achievers with high expectations for almost every area of their lives, too many of them settle for mediocre sex.
Dr. Clayton, who is one of the world’s preeminent experts on women’s sexuality and a psychiatrist with the University of Virginia Health System, exposes and explores this secret in her new book, Satisfaction: Women, Sex, and the Quest for Intimacy, which is scheduled for release by Ballentine/Random House in mid-January.
Young asthmatics reliably describe health status
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The results of a study published in the medical journal Pediatrics indicate that children as young as 7 years old can dependably report on their asthma health status.
“Whether to collect patient-reported data (such as health status or health-related quality of life) from parents or children is an important question in both pediatric research and clinical practice,” Dr. Lynn M. Olson, of the American Academy of Pediatrics, Elk Grove Village, Illinois, and colleagues write.
Drugmakers to pay for FDA review of TV ads
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Drugmakers will have to pay $6.25 million in new fees next year to help fund a U.S. Food and Drug Administration review of television commercials for their products, the agency said Thursday Pharmaceutical companies have been warned in the past about misleading claims.
The advertising plan accompanies an agreement for proposed legislation to renew industry funding for FDA drug reviews through 2012. The FDA also receives money from the federal budget.
Prostate cancer treatment may shorten penis
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Men who receive combination treatment with hormone therapy plus radiation for local or locally advanced prostate cancer may experience a significant reduction in penile length, according to a report in the January issue of the Journal of Urology.
There has been anecdotal evidence that radiation therapy can reduce penile length but, to the authors’ knowledge, the present study is the first to determine if penile length changes following combination treatment with hormone therapy plus radiation.
Pakistan promotes birth control to slow birth rate
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Faced with the prospect of its population doubling to over 300 million people in the next 40 years, Pakistan on Thursday launched a project to promote contraception in urban and industrial areas.
“This initiative has the potential for a major breakthrough in our efforts to bridge the gap between knowledge and practice in inculcating responsible parenthood,” Population and Welfare Minister Chaudhry Shahbaz Hussain told reporters in Islamabad.
Kids in poverty have less parent time: census
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American children living in poverty or in single-parent homes have less interaction with their parents and are more likely to have trouble at school than youths in wealthier, two-parent homes, according to a report released on Thursday.
The U.S. Census Bureau report, “A Child’s Day: 2003,” looked at factors that affect the well-being of American youngsters, only the third time the agency has studied issues affecting children.
Dental X-rays may help detect osteoporosis
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A computer program that analyzes routine dental X-rays could offer a simple, cheap way to detect the bone-thinning disease osteoporosis, new research suggests.
British researchers found that a software program they developed was able to spot signs of declining bone density in dental X-rays of the lower jaw—a potential sign of osteoporosis.
