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Care for Pediatric Depression and OCD

The antidepressant fluoxetine (Prozac) is now approved for treatment of depression and obsessive compulsive disorder (OCD) in children and adolescents 7-17 years of age. This is the first approval of a selective serotonin reuptake inhibitor for treating depression in this population.


The FDA's approval was based on the results of two clinical studies in depressed outpatients. The studies showed a statistically significant effect with the drug compared to placebo on the Childhood Depression Rating Scale R. In children with OCD, fluoxetine produced a statistically significant result compared with placebo on the Children's Yale Brown Obsessive Compulsive Scale.


Common side effects associated with fluoxetine in children and adolescents were similar to those experienced by adults, and include nausea, tiredness, nervousness, dizziness, and difficulty concentrating.


Eli Lilly, the manufacturer of Prozac, is conducting a Phase 4 postmarketing study to further evaluate any potential impact of fluoxetine on long-term growth in children.


Safety Alert Issued on Parkinson's Drug

Eli Lilly has reported that during postmarketing surveillance for pergolide mesylate (Permax), a small number of individuals developed cardiac valvulopathy involving one or more valves during pergolide therapy. The pathologic assessment of the valves that were surgically removed is consistent with the valvulopathy associated with carcinoid syndrome and with the use of other ergot alkaloid drugs.


Even though a clear, causal relationship between the medication and the valvulopathy can't be established, the Warnings section of the labeling for pergolide mesylate will be modified to reflect these case reports.


The aortic, mitral, and tricuspid valves were involved in these reports, and in some cases the symptoms or manifestations of valvulopathy improved with cessation of pergolide therapy. It is not known if fibrotic valvular changes are related to retroperitoneal, pleural, and pericardial fibrosis, which are very rare, but well-known adverse effects associated with pergolide, Eli Lilly states.


Of the estimated 500,000 people who have been treated with pergolide since 1989, valvulopathy has been reported in less than 0.005%.



Topical Treatment for Rosacea Approved


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Azelaic acid (Finecea) gel 15% is now approved for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea. The new treatment is a product of Schering AG.


The results of two phase III studies involving 664 patients with rosacea showed that azelaic acid gel 15% had significantly greater efficacy than its vehicle in reducing the number of inflammatory papules and pustules associated with rosacea. Significant treatment effects were noticeable as early as 4 weeks after therapy began; progressive improvement continued week after week in the two 12-week studies.