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Weekly Drug News Round Up - March 27, 2013

Tecfidera FDA-Approved for Multiple Sclerosis

Tecfidera may decrease white blood cell (WBC) counts; baseline and annual WBC counts are recommended Read More...

Multiple sclerosis (MS) is a central nervous system disease that disrupts communication between the brain and other parts of the body. MS, which results in muscle weakness and difficulty with coordination and balance, affects close to 400,000 people in the U.S. The U.S. Food and Drug Administration (FDA) has approved Tecfidera (dimethyl fumarate), also known as BG-12, an oral, twice daily Nrf2 pathway activator for the treatment of relapsing-remitting multiple sclerosis. Other oral competitors include Aubagio (fingolimod) and Gilenya (teriflunomide).

FDA Approves TOBI Podhaler

Cystic fibrosis is a genetic disease that affects roughly 30,000 patients in the United States Read More...

Cystic fibrosis (CF) patients often have chronic bacterial lung infections due to mucus buildup. The U.S. Food and Drug Administration has approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections. TOBI Podhaler is a handheld inhaler that contains tobramycin dry powder, an antibiotic. In clinical trials, 95 patients age 6 years or older were randomly assigned to receive TOBI Podhaler or a placebo. Patients treated with TOBI Podhaler experienced a statistically significant increase in lung function compared to the placebo group.

Dotarem Okayed for Central Nervous System Imaging

Dotarem is the seventh gadolinium-based contrast agent approved by the FDA for use in patients undergoing CNS MRI Read More...

The U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older. Dotarem is a gadolinium-based contrast agent (GBCA) that helps radiologists see abnormalities on images of the central nervous system (CNS). Dotarem carries a boxed warning about the risk of rare nephrogenic systemic fibrosis (NSF) in patients with kidney disease, characterized by pain and thickening of the skin, and internal organ fibrosis. There is no known treatment for NSF; approved labeling describes ways to minimize the NSF risk.

Clarithromycin Antibiotic Linked With Heart Problems in Lung Disease

Previous research suggests clarithromycin may increase heart failure, heart rhythm disorder and sudden cardiac death risks Read More...

Clarithromycin (Biaxin, Biaxin XL) is a widely used macrolide antibiotic. As published this week in the journal BMJ, researchers found a statistically significant increased risk of heart side effects in patients taking clarithromycin who had lung diseases such as chronic obstructive pulmonary disease (COPD). In a study of 1,300 patients with COPD, 26 percent experienced at least one heart problem over the next year, compared to 18 percent who did not get the drug. Overall, their findings suggest that there would be one additional heart problem for every eight COPD patients who receive clarithromycin, compared to patients who do not receive the antibiotic.

Antipsychotic Use Higher in Medicaid-Insured Kids

From 1997 to 2006, researchers examined the use of antipsychotic drugs among 500,000 children ranging in age from 2 to 17 Read More...

Antipsychotic drugs are traditionally used to treat conditions such as schizophrenia or bipolar disorder, and their off-label use -- when the drugs are used in a different way than has been approved by the U.S. Food and Drug Administration (FDA) -- has resulted in numerous FDA safety warnings. A new study shows that children in the government-funded Medicaid system are receiving antipsychotic treatment five times more often than children with private insurance. In addition, according to researchers, many of the children were diagnosed with behavioral conditions like ADHD, an unapproved use for the drugs. Another study looking at antipsychotic drug use in children was published in September 2012.