News

The spike in flu cases over the past month, along with limited supplies of influenza vaccine and Tamiflu across the United States, has led FDA Commissioner Margaret Hamburg to issue guidance to pharmacists and other healthcare providers.

Flu vaccine 62% effective

The Centers for Disease Control’s (CDC) early estimates of the effectiveness of the seasonal influenza vaccine is 62%.

FDA expanded the approved use onabotulinumtoxinA (Botox, Allergan) to treat adults with overactive bladder (OAB) who cannot use or do not adequately respond to a class of medications known as anticholinergics

Researchers examining the effectiveness of cefixime in the treatment of gonorrhea found a relatively high treatment failure rate, raising concern that gonorrhea may become untreatable, according to results published January 9 in the Journal of the American Medical Association.

FDA has approved sumatriptan iontophoretic transdermal system (Zecuity, NuPathe) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin.

FDA approves crofelemer

FDA’s recent approval of crofelemer (Fulyzaq, Salix Pharmaceuticals, under license from Napo Pharmaceuticals), 125 mg delayed-release tablets, the first anti-diarrheal drug for HIV/AIDS patients taking antiretroviral therapy (ART), is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience noninfectious diarrhea, which often can lead to reduced treatment compliance.

FDA approved the first trivalent influenza vaccine (Flublok, Protein Sciences) made using an insect virus (baculovirus) expression system and recombinant DNA technology for the prevention of seasonal influenza disease in people aged 18 to 49 years.

Merck is halting sales of its cholesterol drug-extended-release niacin/laropiprant (Tredaptive)-after preliminary data from a study showed that it did not achieve its primary end point of reduction of major vascular events and also raised safety concerns.

Fiscal cliff deal shuts down loan program meant to launch state-based co-op health plans; 26 states will miss out.

The new State Health Care Cost Containment Commission aims to create practical solutions for states to manage today’s crushing healthcare costs.

Low-dose aspirin for PCI

Patients with acute coronary artery syndrome and those undergoing percutaneous coronary intervention should be maintained on low-dose aspirin therapy, a recent study demonstrates.

The smoking cessation aid varenicline (Chantix, Pfizer) may increase the risk of cardiovascular events in adults with cardiovascular disease, according to a recent FDA safety announcement.

The American Academy of Pediatrics has announced its endorsement of the World Health Organization?s (WHO) recommendation that thimerosal not be banned from vaccines.

Canagliflozin (Janssen Research & Development), developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, raised the level of bad cholesterol in patients during clinical trials and may post heart risks, according to FDA and reported by Reuters.

In 2012, FDA was able to achieve milestone and make groundbreaking strides through the approval of 39 innovative and cutting-edge drug therapies to populations in need.

Pharmacological resistance to aspirin is rare. Researchers at the University of Pennsylvania in Philadelphia said they could not identify one case of true drug resistance, according to the study published online Dec. 4 in the journal Circulation.

Industry-sponsored studies are more likely to report favorable findings on the sponsor’s drug or device, according to a recent literature review. Healthcare professionals who rely on systematic reviews to aid decision-making should be aware of this industry influence on conclusions.