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Weekly Drug News Round Up - May 27, 2015

FDA Approves Viberzi For Diarrhea-Predominant Irritable Bowel Syndrome

IBS-D is a disorder marked by recurrent abdominal pain or discomfort and altered bowel function Read More...

Irritable bowel syndrome with diarrhea (IBS-D) may affect up to 15 million Americans, especially women, and treatment options are limited. Today, the U.S. Food and Drug Administration approved Actavis’ Viberzi (eluxadoline) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi has mixed opioid receptor activity. In two Phase III trials, Viberzi demonstrated significant superiority over placebo on the endpoint of improvement in both abdominal pain and diarrhea at both 75 mg and 100 mg twice daily doses. Constipation and nausea were common side effects. DEA scheduling will be determined later this year, and product launch is anticipated in Q1 2016.

FDA Approves Stiolto Respimat Spray for COPD

COPD includes chronic bronchitis and emphysema, a serious but treatable lung disease Read More...

Stiolto Respimat is Boehringer Ingelheim’s newly FDA-approved combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA), used for long-term, once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Stiolto Respimat is not to be used for acute symptoms of COPD or for asthma, and does not replace the use of a rescue inhaler. In clinical trials of over 5,000 COPD patients, Stiolto Respimat provided statistically significant improvements in lung function at 24 weeks versus tiotropium (Spiriva) and olodaterol (Striverdi Respimat) alone. The most common side effects with Stiolto Respimat were runny nose, cough and back pain.

FDA Alert: Zerbaxa Dose Confusion and Medication Errors

Dosing errors have not resulted in any side effects in seven reported cases Read More...

The U.S. Food and Drug Administration (FDA) is warning about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the carton labeling. Zerbaxa’s vial label was initially approved with a strength that reflects each individual active ingredient (e.g. 1 g/0.5 g); however, the product is dosed based on the sum of these ingredients (e.g. 1.5 g). To prevent errors, the strength on the drug labeling has now been revised to reflect the sum as 1.5 grams equivalent to ceftolozane 1 gram and tazobactam 0.5 gram.

Metformin: A Workhorse for Type 2 Diabetes

Metformin is recommended in guidelines as the first-line drug treatment for new patients Read More...

A diagnosis of prediabetes or type 2 diabetes can be hard to take. However, there are medicines that work well to control blood sugar, and may even help with weight loss. Metformin, also known by the brand names Glucophage, Glucophage XR, Fortamet, and others, has been available for the oral treatment of type 2 diabetes since 1995. A 2014 study in JAMA Internal Medicine showed that people newly diagnosed with type 2 diabetes who were initially started on metformin were less likely to need other diabetic drug treatments to control their blood sugar. Learn more about metformin here.

Beta-Blockers Before Surgery If Low Heart Risk? Study

Beta-blockers in surgery can lower blood pressure too far in patients without heart risk factors and may cause a fatal stroke Read More...

Research published this week in JAMA Surgery suggests that while patients with three or four heart risk factors should still be given beta-blockers before an operation, people with no risk for heart disease should not receive the drug class. Overall, 43 percent of 325,000 patients undergoing surgery received a beta-blocker. In those who did not receive beta-blockers, 0.5% without heart risk factors died within 30 days after surgery, as did 6.7 percent of those with three to four risk factors. In those who did received a beta-blocker, 1% without heart risk factors died, as did 3.5% of those with three to four heart risk factors.