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Weekly Drug News Round Up - June 25, 2014

Sivextro Approved for Serious Skin and Skin Structure Infections

Sivextro is available for intravenous and oral use

The U.S. Food and Drug Administration (FDA) has approved Cubist Pharmaceutical’s Sivextro (tedizolid phosphate), an antibacterial drug for serious and possibly life-threatening skin infections. Sivextro, available in oral and intravenous forms, is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by bacteria such as Staphylococcus aureus (including methicillin-resistant strains), various Streptococcus species, and Enterococcus faecalis. In clinical trials, Sivextro was as effective as linezolid for skin and skin structure infections. Common side effects include nausea, headache, diarrhea, vomiting and dizziness. On May 23, the FDA also approved Dalvance (dalbavancin) to treat patients with ABSSSI.

FDA Safety Update: Olmesartan Cardiovascular Risks for Diabetics Not Conclusive

Recommendations for use of olmesartan, an angiotensin II receptor antagonist, remain the same Read More...

U.S. Food and Drug Administration (FDA) has completed an investigation into the heart safety risks linked with olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics). The FDA believes the benefits of olmesartan in diabetic patients with high blood pressure continue to outweigh the potential risks. The FDA safety review was prompted by concern that use of olmesartan could result in an increased risk of cardiovascular death, an unexpected finding in the ROADMAP trial evaluating olmesartan use to delay kidney damage in diabetics. To evaluate these findings, FDA reviewed additional studies, including a large study in Medicare patients. Patients should not alter their olmesartan regimen without talking to their doctor.

FDA Alert: Docetaxel Treatment Can Lead to Alcohol Intoxication

FDA is revising the labels of all docetaxel drug products to warn about this risk Read More...

The U.S. Food and Drug Administration (FDA) is warning that the intravenous chemotherapy drug docetaxel (Taxotere) contains ethanol (alcohol), which may cause patients to feel intoxicated during and after treatment. Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and non-small-cell lung cancer. Health care providers should consider the risk of alcohol intake in patients receiving docetaxel, especially those who should avoid alcohol intake or minimize its use due to possible drug interactions.

New Class Labeling for Testosterone Products Warns of Generalized Clot Risk

Venous blood clots as a possible consequence of polycythemia is already included in the labeling of testosterone products Read More...

Manufacturers of all approved testosterone products are now required to include a warning in product labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). This new warning, a class labeling change, is not related to an ongoing FDA evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. FDA is currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in a January 31, 2014 MedWatch Safety Alert.

Bee Pollen Weight Loss Products Linked with Health Risks

FDA has received more than 50 reports of problems caused by tainted bee pollen weight loss products, including at least one death Read More…

As noted by the U.S. Food and Drug Administration (FDA), many bee pollen products make unproven claims about treating or preventing certain diseases, including obesity, allergies, high blood pressure and cholesterol. According to the FDA, the undeclared ingredients sibutramine and/or phenolphthalein have been found in many bee pollen weight loss products, including Zi Xiu Tang, Ultimate Formula, Fat Zero, Bella Vi Amp'd Up, Insane Amp'd Up, and others. Sibutramine was removed from the U.S. market in 2010 due to an increased risk of heart attack and stroke. Phenolphthalein, a laxative and possible cancer-causing agent, is not approved in the U.S.