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Weekly Drug News Round Up - February 5, 2014

Hetlioz Approved For Non-24 Hour Sleep-Wake Disorder in the Blind

Non-24 affects the majority of totally blind individuals, estimated at 100,000 in the U.S. Read More...

The U.S. Food and Drug Administration (FDA) has approved Vanda Pharmaceutical’s Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24-hour sleep-wake disorder (non-24) in totally blind individuals. Non-24 is a chronic, circadian rhythm disorder resulting from the misalignment of the internal body clock to the 24-hour day, disrupting the sleep-wake cycle. This is the first FDA approval of a treatment for the disorder. Hetlioz was evaluated in a clinical study of 104 completely blind people. Reported side effects included headache, elevated liver enzymes, unusual dreams and infections of the upper respiratory or urinary tract.

FDA: Evaluating Bayer’s Aleve as a Safer NSAID

Naproxen was included in the 2005 class labeling that warned of heart risks for all nonsteroidal antiinflammatory drugs (NSAIDs) Read More...

Naproxen is an NSAID pain and fever reliever first approved in 1976, and is available in both prescription (Naprosyn, EC-Naprosyn) and over-the-counter (Aleve, generic) products. This week the U.S. Food and Drug Administration (FDA) stated that naproxen may pose a lower risk of heart attack and stroke than ibuprofen which is another widely used NSAID found in Advil, Motrin and generics. Next week an advisory panel of outside experts will discuss the new data and recommend to the FDA whether naproxen should be relabeled to emphasize greater heart safety compared to other NSAIDs such as ibuprofen.

FDA Launches Educational Anti-Smoking Campaign; CVS Pulls Tobacco Products

The FDA states that "The Real Cost" campaign ads will run nationwide beginning on February 11 Read More...

The U.S. Food and Drug Administration (FDA) has launched its first public health education campaign -- "The Real Cost” -- to prevent and reduce tobacco use among at-risk young people ages 12 to 17. Over 3,200 youth under the age of 18 smoke their first cigarette every day in the U.S -- and another 700 become daily smokers. FDA will use advertising on TV, radio and the Internet, as well as in print publications, movie theaters and outdoor locations to highlight the effects of smoking such as loss of control due to addiction and health effects like tooth loss and skin damage. In a similar effort, CVS Caremark has said it will stop selling tobacco products at more than 7,600 stores across the U.S.

Testosterone Therapy for “Low-T” May Pose Heart Risks

Testosterone therapy typically is given in gel, patch or injection form, and is widely promoted in TV ads Read More...

The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products based on recent reports of increased cardiovascular risk. Testosterone therapy has been aggressively marketed towards men with possible “Low-T”, or low testosterone levels, as a way to boost sex drive and energy. In recent studies, results have pointed to an increase risk for heart attacks in younger at-risk men and in older men without heart risks. According to researchers, heart attack risk doubled for both groups in the 90 days after the men began testosterone therapy.

Young Americans With HIV Are Delaying Treatment: Study

HIV testing is recommended at least once for everyone between the ages of 13 to 64, according to the CDC Read More…

Early treatment for HIV has been shown beneficial in helping to prevent heart, kidney and neurological harm that may occur in uncontrolled HIV disease. In a recent study published in JAMA Pediatrics, researchers analyzed the medical records of nearly 1,500 HIV-infected teens and young adults. Of those, up to 45 percent sought treatment only when their infection was at an advanced stage. Males and minorities may be at even higher risk for untreated advanced HIV disease. Experts suggest pediatricians should encourage teens to think of HIV testing as a normal part of their regular physical, and doctors should consider testing for HIV across the board.