News in brief - Nov. 1, 2004

SSRI warning ordered by FDA - Alzheimer's study would measure cognitive impairment - Sinusitis study supports treatment with antifungals - Study reinforces need for nutritional counseling after bariatric surgery

SSRI warning ordered by FDA

All antidepressant drugs will now carry labels that include a boxed warning alerting physicians and others to the increased risk of suicide they pose to children and adolescents, according to an Oct. 15 public health advisory issued by the Food and Drug Administration.

The warnings are to appear on more than 30 antidepressants including the popular selective serotonin reuptake inhibitors, or SSRIs, such as Prozac (fluoxetine), which is approved for treating manic-depressive disorder in children and Zoloft (sertraline), which is approved for obsessive compulsive disorder in children.

The FDA's action puts in force the recommendation made by its advisory panels in September. An analysis of SSRIs showed that the risk of such adverse events as having suicidal thoughts was twice as great for young patients on antidepressants as it was for those on placebo.

The warning is to include the following points: antidepressant drugs increase the risk of suicidal thinking and behavior in children and adolescents with psychiatric disorders; anyone considering using them for young people should weigh the risk versus the benefit; patients should be observed particularly closely when they start therapy; and families and caregivers should be advised to closely monitor children and speak frequently to the physician about any concerns.

Guides with information on the antidepressants will also be distributed by pharmacists with each new prescription or refill, said the FDA.

Alzheimer's study would measure cognitive impairment

A new Alzheimer's disease study will be exploring whether brain imaging technologies, biomarkers and clinical and neuropsychological assessments can be combined to measure the progression of the mild cognitive impairment that marks early Alzheimer's disease.

The study is intended to help speed the development of treatments and monitor their effectiveness. The new initiative was announced on Oct. 13, at the AMA's Annual Science Reporters Conference held in Washington, D.C.

The $60 million, five-year-study will enroll 800 adults at 50 sites across the U.S. and Canada. It is a novel public-private effort of the National Institute on Aging, the Alzheimer's Assn., several pharmaceutical and imaging equipment companies, the Institute for the Study of Aging and other government agencies.

Recruitment of subjects ages 55 to 90 will begin in April 2005. Two hundred cognitively normal individuals will be followed for three years, 400 people with mild cognitive impairments will also be followed for three years and 200 people with early Alzheimer's disease will be followed for two years.

Data produced by the Alzheimer's Disease Neuroimaging Initiative is to be made public quickly to further the goal of hastening discoveries.

There are currently no drugs that halt the disease, and the aging of the population is expected to boost the numbers of people with Alzheimer's disease in the near future.

Sinusitis study supports treatment with antifungals

People with chronic sinus inflammation were found to have an exaggerated immune response to common airborne fungi showing a possible immunologic basis for chronic sinusitis.

Research results published in the Oct. 12 online edition of The Journal of Allergy and Clinical Immunology demonstrate a possible starting point for a better understanding of the condition, which was diagnosed in nearly 30 million people in the United States in 2002.

Despite its prevalence, the condition is poorly understood, said Marshall Plaut, MD, chief of the National Institute of Allergy and Infectious Diseases, which funded the study.

Researchers at the Mayo Clinic in Rochester, Minn., compared blood samples taken from 18 people diagnosed with chronic sinusitis with samples from 15 healthy volunteers. Nasal secretions from the two groups were also examined for fungal proteins and inflammation-causing immune system molecules.

There has been some controversy over earlier reports by Mayo scientists that patients with chronic sinusitis can be successfully treated with antifungal agents because the results of those studies were not able to be replicated by others. This study, said Hirohito Kita, MD, of the Mayo Clinic, supports the rationale of treating chronic sinusitis with antifungals.

Study reinforces need for nutritional counseling after bariatric surgery

Bariatric surgery for morbid obesity was found to result in more peripheral neuropathy than did gallbladder surgery, according to a study published in the Oct. 26 issue of Neurology.

The conditions ranged in severity from the more common carpal tunnel syndrome to less common pain and weakness that led to wheelchair use for some patients.

The study also showed that good follow-up care and nutritional counseling can prevent the complications, said P. James B. Dyck, MD, principal investigator on the study and associate professor of neurology at the Mayo Clinic College of Medicine in Rochester, Minn.

The study compared the charts of 435 people who had one of two types of bariatric surgery approved for treating morbid obesity with the charts of 123 obese patients who had gallbladder surgery.

The risk factors that correlated with peripheral neuropathy included very rapid weight loss, not taking vitamins and prolonged nausea and vomiting. Factors such as age, gender, presurgery body mass index and general health had no effect. "A major risk factor correlated with PN after surgery was failure to attend a nutritional clinic. The evidence was very strong that PN complications were associated with malnutrition," said Dr. Dyck.