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Weekly Drug News Round Up - June 3, 2015

Qudexy XR Gains Indication for Younger Pediatric Population

Qudexy XR can be sprinkled onto soft food to ease dosing in young patients Read More...

Qudexy XR (topiramate) extended-release capsules has been FDA-approved for use as initial monotherapy in patients two years of age and older who are experiencing partial-onset seizures (POS) or primary generalized tonic-clonic seizures. Qudexy XR was previously approved for this indication in patients 10 years and older. Qudexy XR is also approved as an added treatment to other medicines for patients two and older with POS, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Qudexy XR is given orally once-a-day.

FDA Warning: Unintentional Injection of Soft Tissue Fillers

Cosmetic soft tissue fillers are used to reduce the appearance of wrinkles or to augment lips or cheeks Read More...

The U.S. Food and Drug Administration (FDA) is warning that unintentional injections of soft tissue (dermal) fillers (for example, Restylane or Juvederm) into blood vessels can be associated with rare but serious side effects. Blood vessels may become blocked and may result in embolization which can cause vision impairment, blindness, stroke and damage and/or death of the skin or facial structures. Patients should ask their healthcare provider about their training and experience in injecting soft tissue fillers in the face prior to treatment. See FDA recommendations for patients and healthcare providers regarding dermal fillers.

FDA Approves Rapamune For Rare Lung Disease

Only two and five women per million women worldwide are known to have lymphangioleiomyomatosis Read More...

The U.S. Food and Drug Administration (FDA) has approved Wyeth’s oral Rapamune (sirolimus) as the first drug to treat lymphangioleiomyomatosis (LAM). LAM is a rare, progressive lung disease, causing cysts which lead to breathing problems and primarily affects women of childbearing age. Rapamune was first approved in 1999 as an immunosuppressive agent to help prevent kidney transplant rejection. In clinical trials, 89 patients either received Rapamune or placebo for a 12-month period. The primary endpoint, forced expiratory volume in one second (FEV1), decreased an average of 153 milliliters in the Rapamune group. Common side effects included mouth ulcers, diarrhea, nausea, chest pain, elevated cholesterol, and leg swelling.

Opdivo Shows Promise Against Advanced Lung Cancer

Lung cancer is the most common cancer worldwide, and the leading cause of cancer deaths in the U.S. Read More...

Immunotherapy is leading to major strides in cancer treatment. Nivolumab (Opdivo) is called an immune checkpoint inhibitor and works by turning on the body’s immune system to destroy cancer cells. Researchers have reported on a trial involving 582 patients with non-small cell lung cancer, randomly assigned to receive either nivolumab (Opdivo) or docetaxel (Taxotere). All patients had received a prior chemotherapy regimen, but had worsening advanced lung cancer. Overall median survival was 12.2 months in the nivolumab group compared to 9.4 months in the docetaxel group. Only one in 10 patients experienced serious side effects with nivolumab, compared to over 50 percent of patients taking docetaxel.

Statin Drugs May Improve Outcomes After Heart Bypass

These findings further reinforce current guideline recommendations

Coronary artery bypass graft surgery, or CABG, is performed for patients suffering from severely clogged arteries to reroute blood flow around such blockages. New research in over 16,000 heart patients, the majority of whom were on statin, shows that this class - and especially the drug Zocor (simvastatin) - was linked to a 65 to 74 percent lower risk of death following CABG. However, 15 percent of patients were not on a statin at the time of the study, and researchers question whether this group would benefit from short-term statin therapy around the time of their operation.