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Weekly News Round Up - January 25, 2012

Zetonna Nasal Aerosol Approved For Allergic Rhinitis

Zetonna (ciclesonide) Nasal Aerosol approved for patients 12 years and older; corticosteroid delivered as fine dry mist Read More...

Zetonna (ciclesonide) has been approved as a once-daily nasal spray for the treatment of seasonal and perennial rhinitis. Zetonna is formulated with an environmentally friendly hydrofluoroalkane (HFA) propellant and delivered as a small volume, fine dry mist. A 26-week, Phase III, placebo-controlled study in over 1,100 patients age 12 years or older showed statistically significant improvements in nasal symptoms with Zetonna after the first 6 weeks of treatment. The approved dose is one actuation (74 mcg) per nostril once daily. Ciclesonide is also available as Omnaris for allergic rhinitis and Alvesco for asthma.

Viread Approved for HIV Treatment in Children 2 to 12 Years of Age

Viread tablets approved for children 6-12 years; oral powder form approved for 2 to 5 year olds Read More...

Viread (tenofovir disoproxil fumarate), in combination with other antiretroviral agents, is now approved for pediatric age groups 2 years and older with HIV infection. The lower-strength tablets (150, 200 and 250 mg) are approved for ages 6 to 12, and a new oral powder formulation will be available for children 2 to 5 years and for older patients unable to swallow tablets. Dosing of once-daily Viread in the pediatric population is based on weight. The new oral powder is mixed with a soft food, such as applesauce, yogurt or baby food for administration. Previously in pediatrics, only the 300 mg dose was approved for adolescents 12 to 17 years of age. Patients should not use Atripla, Complera, or Truvada while also taking Viread, as they all contain tenofovir disoproxil fumarate.

Tysabri: New Risk Factor for Progressive Multifocal Leukoencephalopathy

An additional risk factor for developing progressive multifocal leukoencephalopathy (PML) has been identified for Tysabri use Read More...

Progressive multifocal leukoencephalopathy (PML) is a rare but serious viral brain infection associated with the use of Tysabri (natalizumab), an immunomodulator used in multiple sclerosis and Crohn’s disease. Testing positive for anti-JC virus (JCV) antibodies is now considered another risk for developing PML. The risks and benefits of continuing natalizumab should be carefully weighed in patients who are found to be anti-JCV antibody positive and who also have one or more other known risk factor for PML. Additional risk factors include long-term natalizumab therapy, especially over 2 years, and use of certain immunosuppressants, such as mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil. The FDA has approved a new diagnostic tool, the Stratify JCV Antibody ELISA test, to detect anti-JCV antibodies.

Lancet Study: Avodart May Slow Early Stage Prostate Cancer

Avodart treatment may allow surveillance of slow-growing prostate cancer and avoid effects of surgery and radiation Read More...

As reported this week in The Lancet, men may be more willing to actively engage in surveillance of an early stage prostate cancer diagnosis, rather than more radical treatment such as surgery and radiation. Avodart (dutasteride), a 5-alpha reductase inhibitor already approved for use in symptomatic benign prostatic hypertrophy, was shown in a three-year study to lower rates of prostate cancer progression from 48 percent in the placebo group (n=145) to 38 percent in the Avodart group (n=144). However, the U.S. Food and Drug Administration has warned that use of 5-alpha reductase inhibitors might actually increase the risk for high-grade prostate cancer, so the role that Avodart may eventually have in slowing early-stage prostate cancer may be controversial among health care providers and patients.

Education Needs: Encourage Regular Sunscreen Use in Young Teens

Study shows only 1 in 4 younger teens use sunscreen regularly; childhood sunburn a lifelong skin cancer risk-factor Read More...

A study in the journal Pediatrics shows that rates of sunscreen use in surveyed adolescents dropped from roughly 50 percent at age 11, down to 25 percent at age 14. Researchers found that 53 percent of the children had already experienced at least one sunburn by age 11 (a risk factor for skin cancer development), and the rate of sunburn was constant up through the age of fourteen. Adolescents also reported that they liked having a tan and increased their time outside to get tanned. Researchers encourage additional educational outreach to inform children in these age groups about healthy choices to ward off skin cancers in their lifetimes.