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Long-term use of a combination antimicrobial trimethoprim–sulfamethoxazole (TMP/SMZ) reduces the risk of recurrent urinary tract infection (UTI) by up to 80% in children with the urinary condition vesicoureteral reflux compared to placebo, according to a study published online May 4 in the New England Journal of Medicine.

FDA approved vorapaxar (Zontivity, Merck Sharp & Dohme Corp., a subsidiary of Merck) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.

FDA approved omega-3-carboxylic acids (Epanova, AstraZeneca) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

The National Lipid Association just released a report addressing six safety issues related to statin therapy, including the effects of statins on cognition, diabetes risk, liver function, muscle symptoms, interactions with other drugs, and statin intolerance. The report, published in the Journal of Clinical Lipidology, is an update to a consensus report published by the organization in 2006.

The sale of electronic or e-cigarettes may soon be regulated by FDA. Last week the agency proposed a new rule that would extend its authority to cover additional tobacco products, including e-cigarettes.

An FDA advisory panel recommended against Merck’s attempt to sell its prescription drug, montelukast sodium (Singulair), as an over-the-counter product for allergy relief in adults only.

The increase in recent acquisition activity among Big Pharma illustrates different growth strategies, according to industry watchers.

FDA approved umeclidinium (Incruse Ellipta, GlaxoSmithKline) once-daily anticholinergic for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Assessing the clinical utility of diagnostic testing has always been a complicated undertaking. And as new genetic tests enter the equation, that complexity will only increase. To examine the issues surrounding clinical utility, I’d like to share a quick story.

FDA drug approvals, breakthrough designations, fast-track designations, priority review

Patients who use statins are consuming more calories and fats than a decade earlier, increasing the risk of obesity, diabetes, and cardiovascular disease, according to a study published online in JAMA Internal Medicine.

Pfizer said it offered to buy AstraZeneca for approximately $100 billion. If the deal materializes, it would represent the biggest-ever foreign takeover of a British business and allow Pfizer to pay a lower corporate tax rate of 20%, according to some reports.

The biggest challenge in tackling opioid abuse is lack of awareness and understanding of addictive diseases generally and specifically opioid use disorders, as well as misinformation and negative perceptions of medication-assisted therapies (MATs), according to a recent opinion article published in the New England Journal of Medicine.

Pharmacists who contacted high-risk patients within 72 hours of discharge from Massachusetts General Hospital, Boston, found more than half of the patients had medication-related issues. In a different group of high-risk patients who had received inpatient interventions, 35% of patients were found to have issues after a pharmacist reviewed their medications just prior to discharge, according to Laura Carr, PharmD.

Pharmacist-led care with prescribing authority substantially improved risk factors at 6 months among stroke survivors than nurse case managers who monitored patients and provided feedback to their primary care physicians, according to a report published in the Canadian Medical Association’s journal, CMAJ.

FDA approved the first HPV DNA test for women aged 25 years and older that can be used alone to help a healthcare professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can offer information about the patient’s risk for developing cervical cancer in the future.