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Weekly Drug News Round Up - September 19, 2012

FDA Investigates Risk of Heart Failure With Mirapex

Patients should continue their Mirapex medication as directed by their health care provider Read More...

The U.S. Food and Drug Administration (FDA) is reviewing data to determine if there is an increased risk of heart failure with Mirapex (pramipexole) based on results of recent studies. Mirapex, a dopamine agonist, is indicated for the treatment of symptoms of Parkinson's disease, as well as restless legs syndrome. In a pooled analysis of clinical trials, it was found that heart failure was more frequent with Mirapex than with placebo, but the results were not statistically significant. FDA also evaluated two epidemiologic studies that suggest an increased risk of new onset heart failure with Mirapex use. FDA will update the public when new information is available.

Study Reviews Warfarin Use After GI Bleeding

In the 90 days after a GI bleed, patients who resumed warfarin had significantly lower risk of thrombosis and death Read More...

Warfarin is a blood thinner used to help prevent clot formation that leads to conditions such as stroke and heart attack. However, about 4.5 percent of patients treated with warfarin have an episode of gastrointestinal (GI) tract bleeding. In the Archives of Internal Medicine, a retrospective cohort study of roughly 440 patients showed that those who stopped taking their warfarin after they developed a GI bleed, but resumed the drug within 90 days, had a significantly lower risk of thrombosis and death. In addition, the lower risk of thrombosis and death was not accompanied by a significant increase in the risk of a recurrent GI bleed.

Weight Loss Drug Qsymia Launched

Worldwide there are more than 500 million obese people, with over 78 million in the U.S. Read More...

Vivus’ Qsymia (phentermine and topiramate extended-release) has been launched into the U.S. market. Qsymia is FDA-approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult overweight or obese patients with at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol. Arena’s Belviq (lorcaserin) was FDA-approved over the summer, but launch is not expected until Q1 2013, and Orexigen Therapeutic’s Contrave (naltrexone SR/bupropion SR) is anticipated to undergo an FDA review in 2014. Qsymia and Belviq are the first new weight loss drugs approved by the FDA in over 13 years.

Genzyme’s Aubagio Approved for Multiple Sclerosis

Label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity, based on animal data Read More...

The U.S. Food and Drug Administration (FDA) has approved Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). Aubagio, an oral pyrimidine synthesis inhibitor, has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI. Aubagio is an immunomodulator with anti-inflammatory properties and may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).

Topical Pain Relievers May Rarely Cause Skin Burns

Common OTC pain creams and gels marketed to provide “warmth” or “coolness” may rarely burn skin, FDA warns Read More...

The U.S Food and Drug Administration (FDA) is warning that certain over-the-counter (OTC) products that are rubbed into the skin for the relief of mild muscle and joint pain have been reported to cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burns. Products containing menthol, methyl salicylate, or capsaicin, and marketed under various brand-names such as Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum may lead to the side effect. The FDA advises that the products should not be used on irritated or damaged skin, and not to cover the medicated area with bandages, heating pads, or other heat sources.

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