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Weekly Drug News Round Up - October 9, 2013

FDA Warns Consumers of Liver Damage with OxyElite Pro

The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro Read More...

The U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH) are investigating 29 cases of acute non-viral hepatitis in Hawaii. All cases share a common link to a dietary supplement product labeled as OxyElite Pro. Eleven of the 29 cases have been hospitalized with acute hepatitis, two cases have received liver transplants and one person has died. Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice. Consult with your doctor if you have used OxyElite Pro.

Bayer’s Adempas Approved Under Priority Review for Pulmonary Hypertension

Adempas is the first drug therapy for chronic thromboembolic pulmonary hypertension, previously surgery was the standard option Read More...

Pulmonary hypertension is a devastating, life-threatening condition caused by excessively high blood pressure in the lung arteries that puts stress on the heart. Adempas (riociguat) has been approved for patients with chronic thromboembolic pulmonary hypertension (CTEPH) and for patients with pulmonary arterial hypertension (PAH). Adempas is an oral guanylate cyclase stimulator that helps to relax arteries, increase blood flow, and decrease blood pressure. Clinical trials met their primary endpoint of significant improvement in the six-minute walk test after 12 and 16 weeks. Female patients can receive the drug only through the Adempas REMS program due to possible fetal risk.

Pfizer’s Duavee Okayed for Hot Flashes and Osteoporosis in Menopause

For the prevention of osteoporosis, Duavee should only be used only for women at significant risk; consider non-estrogen medication first Read More...

Duavee (conjugated estrogens/bazedoxifene) has been approved by the U.S. Food and Drug Administration (FDA) to treat menopause-related hot flashes and for osteoporosis prevention in women with uterus. Duavee is an estrogen agonist/antagonist and conjugated estrogens combination. Duavee uses bazedoxifene, instead of a progestin, to help protect against uterine hyperplasia that may result from estrogen-alone treatment. Women taking the drug had 74 percent fewer moderate-to-severe hot flashes after 12 weeks of treatment, compared with a 47 percent reduction among women who took a placebo. Blood clots and uterine cancer are a risk with estrogen use; women should discuss treatment options with their provider.

FDA Approves Clinolipid to Reduce Shortage of Injectable Lipid Emulsions

Clinolipid is not indicated for use in preterm infants or other pediatric patients Read More...

The U.S. Food and Drug Administration (FDA) has approved Clinolipid (lipid injectable emulsion, USP) for intravenous (IV) nutrition under a priority review to help alleviate a shortage. Clinolipid provides a source of calories and essential fatty acids for adult patients who are unable to eat or drink. Clinolipid is a lipid emulsion that contains a mixture of refined olive oil and soybean oil and provides an important source of energy in patients receiving IV nutrition. Clinolipid is intended for adults, and like other intravenous lipid emulsions, should be used with caution in patients with preexisting liver disease or liver insufficiency.

First Effective Malaria Vaccine May Soon Be Available

In Africa alone, nearly 600,000 deaths occur each year from malaria, mainly in children under 5 years of age Read More…

Promising results from a large-scale clinical trial suggests a malaria vaccine could be on the market by 2015. In a Phase 3 clinical trial of more than 15,000 infants and young children in Africa, the vaccine -- called RTS,S -- continued to protect the youngsters from malaria for up to 18 months after vaccination. Dependent upon age, there was a 27 to 46 percent reduction in the number of malaria cases (from 444 to 941 fewer cases of malaria for every 1,000 children). Based on the data, vaccine maker GlaxoSmithKline plans to apply next year to have the vaccine approved by the European Medicines Agency.