Pharmacy

New molecular entity: Telavancin for injection (Vibativ) was approved on September 11, 2009, for the treatment of complicated skin and skin-structure infections (cSSSIs)

Fampridine-SR is a sustained-release oral medication that is pending FDA approval for the symptomatic treatment of multiple sclerosis (MS).

Specialty pharmacies are uniquely positioned to play a key role in the implementation of Risk Evaluation and Mitigation Strategies (REMS).

Even before the emergence of the swine flu pandemic, biopharmaceutical companies were investing in vaccines and treatments for lethal diseases that plague much of the world. There is growing recognition that Americans and Europeans are vulnerable to infections from overseas, and that development of new medications is critical to ensuring public health.

New indication: Bevacizumab (Avastin), a monoclonal antibody, was approved on July 31, 2009, for the treatment of metastatic renal cell carcinoma in combination with interferon alfa

Generic drug approved by FDA (through September 2009): tacrolimus capsules

The P&T committee is positioned to provide knowledge, strategies to improve treatment of patients with cardiometabolic disorders.

New molecular entity: Saxagliptin (Onglyza), a DPP-4 inhibitor, was approved on July 31, 2009, for the treatment of type 2 diabetes mellitus

New formulation: Sumatriptan (Sumavel DosePro) formulated as a needle-free injection was approved on July 15, 2009, for the acute treatment of migraine and cluster headaches

Golimumab is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody that was recently approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

In a retrospective analysis published in the journal Neurology, investigators demonstrated that previous treatment with intravenous immunoglobulin (IVIg) was associated with a reduced risk of the development of Alzheimer's disease and related disorders (ADRD) in patients aged at least 65 years.

This review discusses emerging risk factors for CVD, including hs-CRP, lipoprotein(a), homocysteine, fibrinogen, homocysteine, and coronary artery calcification.

Rivaroxaban is a highly potent direct factor Xa inhibitor that is pending FDA approval for the indication of venous thromboembolism (VTE) prophylaxis in patients undergoing total knee replacement or total hip replacement surgery.

Generic drug approved by FDA (through August 2009): ethinyl estradiol/norgestimate tablets

New molecular entity: Dronedarone (Multaq), a benzofuran derivative, was approved on July 1, 2009, to reduce the risk of CV hospitalization in patients with AF

New molecular entity: Prasugrel (Effient), a platelet activation and aggregation inhibitor, was approved on July 10, 2009, to reduce the rate of thrombotic CV events in patients with ACS undergoing PCI

A matched, case-control analysis demonstrated an association between the use of stimulant medications (used to treat attention-deficit/hyperactivity disorder [ADHD]) and sudden unexplained death in children and adolescents.

Generic drug approved by FDA (through July 2009): melphalan injection

This review highlights treatment guidelines, disease staging criteria, and new therapeutic approaches to MM, including an overview of supportive care and emerging pipeline agents.

New indication: Tadalafil (Adcirca), a phosphodiesterase type 5 inhibitor, was approved on May 22, 2009, for the treatment of pulmonary arterial hypertension (WHO Group I)

New molecular entity: Tolvaptan (Samsca), a vasopressin receptor antagonist, was approved on May 19, 2009, for the treatment of clinically significant hypervolemic and euvolemic hyponatremia

Milnacipran was recently approved by FDA for the management of fibromyalgia syndrome. Clinical trials have demonstrated that this agent may be a reasonable alternative or adjunct therapy for patients with fibromyalgia syndrome who are unable to tolerate first-line tricyclic antidepressant therapy.

New indication: Zoledronic acid (Reclast), a bisphosphonate, was approved on May 29, 2009, for the prevention of osteoporosis in postmenopausal women

Pfizer is discontinuing a phase 3 study of sunitinib plus paclitaxel versus bevacizumab plus paclitaxel for the first-line treatment of patients with advanced breast cancer.

FDA has notified healthcare professionals that there is a risk of serious liver injury, including liver failure or death, with the use of propylthiouracil in both adult and pediatric patients.

Centocor Ortho Biotech has issued a Dear Healthcare Professionals letter to remind healthcare providers that golimumab (Simponi), a tumor necrosis factor (TNF)-alpha blocker, is associated with a risk of serious fungal infections.

Prescribing psychotropic medications for attention-deficit/hyperactivity disorder (ADHD) and other disorders in children is common around the world, even though serious adverse drug reactions (ADRs) have been reported with the use of these drugs, said speakers at the American College of Clinical Pharmacy (ACCP)/European Society for Clinical Pharmacy (ESCP) International Congress on Clinical Pharmacy meeting in Orlando, Florida.

Results from the Regulation of Coagulation in Orthopaedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism 4 (RECORD4) trial published in Lancet demonstrated that rivaroxaban 10 mg once daily is superior to subcutaneous (SC) enoxaparin in preventing venous thromboembolism (VTE) after total knee arthroplasty.

The economic stimulus package approved by Congress in February provides more than $1 billion to support research on competing medical treatments. Although a fairly minor piece of the larger $789 billion American Recovery and Reinvestment Act of 2009 (ARRA), the provision set off widespread reaction to the possibility that comparative study results may be used to limit coverage of more expensive medicines.

Osteoarthritis (OA) is the most common form of arthritis and the leading cause of disability in the United States, especially among older adults. This article reviews nonpharmacologic and pharmacologic approaches to management of OA of the knee and hip.