Formulary Watch |

FDA warns of potential risk of liver injury with use of tolvaptan

Healthcare professionals have been notified by Otsuka and FDA of significant liver injury associated with the use of tolvaptan (Samsca, Otsuka).

FDA approves deferasirox to remove excess iron in patients with genetic blood disorder

FDA has expanded the approved use of deferasirox (Exjade, Novartis) to treat patients aged 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).

Flu vaccine shortage elicits FDA guidance

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 approves Botox to treat overactive bladder

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

Study raises concern over cefixime failure rate for gonorrhea

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 approves first migraine patch

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.

AMCP urges CMS to evaluate existing quality measures for use in exchanges

The Academy of Managed Care Pharmacy (AMCP) recommends that the Centers for Medicare & Medicaid Services (CMS) evaluate existing national quality health measures before implementing quality metrics in state health insurance Exchanges starting in 2016.

FDA approves new seasonal flu vaccine made using novel technology

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.

FDA approves budesonide for the induction of remission in patients with active, mild to moderate ulcerative colitis

FDA has approved budesonide (Uceris, Santarus and Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals SpA) extended-release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

FDA approves drug for blood clotting disorders

FDA approved a pooled plasma (human) blood product (Octaplas, Octapharma) for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels.

Merck tells physicians to stop prescribing Tredaptive

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.

Web-based program aids clinicians in anticoagulation treatment

A new web-based program aims to help clinical pharmacists and other healthcare professionals achieve the best possible outcomes for their patients on antithrombotic medications.

Study offers guidance for use of acid-suppressive medications in hospital patients

New findings could help physicians to selectively use acid-suppressive medications when needed, and avoid using them when there is no indication that patients are at risk

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.

Varenicline and cardiovascular risk

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.

Thimerosal use in vaccines

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 may not be good for the heart, FDA says

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.

FDA has banner year with 39 new drug approvals

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.

FDA approves apixaban

Aspirin resistance is rare

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 report more favorable findings

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.

Analgesics linked to hearing loss in women

Women who regularly took the analgesics ibuprofen or acetaminophen 2 more days per week had an increased risk of hearing loss, according to a recent study published in a recent issue of the American Journal of Epidemiology.

Antimicrobial stewardship programs-A review for the formulary decision-maker

Antimicrobial stewardship programs are being implemented in a variety of settings to assist with the challenges associated with the management of infectious diseases. Here's a review of ASPs from the perspective of a formulary decision-maker.

From the American Society of Hematology Annual Meeting- Positive new JAK2 for myelofibrosis shows promise

With limited treatments available, the discovery of mutations in Janus kinase 2 (JAK 2) in 2005 was a major step forward for scientists in search of new therapies for myeloproliferative neoplasms (MPNs).

American Academy of Pediatrics- Retain thimerosal for global vaccine use

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

Benzodiazepines may increase risk of CAP, mortality

Benzodiazepines, which have been associated with an increased incidence of infections in the critically ill, also may increase the risk of community-acquired pneumonia, according to a recent report published in Thorax.

Medication-related adverse events tied to ED visits in the elderly

Adverse drug events in the elderly can be prevented with appropriate monitoring, according to CDC.

Manage periodontal disease to rein in pharmacy costs

A study of 1.7 million patients with diabetes indicates that reducing inflammation of the mouth can produce improvement in other health measures.