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Weekly Drug News Round Up - November 20, 2013

Valeant’s Luzu Cream Approved for Skin Fungal Infections

Topical antifungal cream targets athlete’s foot, jock itch, and ringworm Read More...

The U.S. Food and Drug Administration has approved Luzu (luliconazole) Cream, 1%, for the adult treatment of several skin fungal infections, including athlete's foot in between toes (interdigital tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. Luzu is applied in a one-week, once-daily treatment regimen for tinea cruris and tinea corporis. Other topical antifungal products, such as econazole, clotrimazole or ketoconazole require a 2-4 week treatment period. However, treatment with Luzu for interdigital tinea pedis is only approved with a two-week, once-daily treatment.

FDA Drug Safety: OTC Topical Antiseptics

The FDA is requesting label changes and single-dose packaging to help prevent infections from tainted topical antiseptics Read More...

Topical antiseptics are frequently used to reduce the number of bacteria on skin prior to surgery or injections. Contamination of these products can occur when a user allows organisms such as bacteria into the package. Due to this concern, the U.S. Food and Drug Administration is requesting label and packaging changes for antiseptic products labeled for preoperative or pre-injection skin preparation. Affected products included all commonly used antiseptic ingredients, including alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products. These products are marketed as solutions, swabs, pads saturated with a solution, and applicators containing a solution.

Validity of Online Heart Risk Calculator Questioned by Some Experts

Estimates of those who should use statins are said to be incorrect Read More...

New guidelines addressing heart health, obesity and associated risk factors were released last week, but according to experts in Boston the online calculator meant to assess a patient's 10-year risk of cardiovascular disease is flawed. In the guidelines statin cholesterol-lowering therapy is recommended in those 40 to 75 years of age with an estimated 10-year risk of cardiovascular disease of 7.5% or more; however, experts contend that the calculator can overestimate by millions the number of people that should be taking these drugs. Officials from heart groups that developed the calculator respond that it is a tool that suggests certain people would benefit from statins, but ultimately that is a patient-physician decision.

Should Aspirin Be Dosed at Bedtime?

New, but early research suggests the daily dose of aspirin may be more protective for the heart if taken at bedtime Read More...

Heart attacks and strokes occur more frequently in the morning, and researchers believe it may be due to enhanced platelet activity at that time of day. Preliminary research involved nearly 300 heart attack survivors. During two separate periods, half the patients took 100 milligrams of aspirin in the morning while the other half took the same dose at bedtime. Researchers found that taking aspirin at bedtime reduced platelet activity more than taking it in the morning, apparently because it lowers the normal morning platelet activity. This study did not prove that aspirin dosed at bedtime could prevent more heart attacks or strokes; additional research is needed for that outcome.

Pediatric ER Visits Drop After Cough and Cold Label Changes

Serious adverse events reported with cough and cold products include death, convulsions, rapid heart rates, and decreased levels of consciousness Read More...

A new study published in Pediatrics demonstrates a drop in emergency room visits for small children after drug labeling changes were put in place in 2008. In children under 2, side effects due to cough and cold medicines made up 4.1 percent of all adverse drug event emergency department (ED) admissions before the label changes and dropped to 2.4 percent after the changes took effect. In those aged 2 to 3 years, ED visits made up 9.5 percent of all adverse drug event admissions but dropped to 6.5 percent after the changes. There are safer options to treat a cold in a child less than 4 years of age.