Drug Pipeline

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.

Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue that is currently pending FDA approval for the treatment of type 2 diabetes. This agent mimics the actions of food-induced endogenous GLP-1 release, thus causing glucose-dependent increased insulin secretion, decreased glucagon secretion, and reduced appetite and gastric emptying.

Generic drugs approved by FDA (through May 2009) including drospirenone and ethinyl estradiol, levalbuterol, and topiramate

New indication: Tigecycline (Tygacil), a tetracycline-class antibiotic, was approved on March 20, 2009, for the treatment of community-acquired bacterial pneumonia

New molecular entity: Everolimus (Afinitor), an antineoplastic agent, was approved on March 30, 2009, for the treatment of advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib

Because so many people nowadays seem to be using cell phones rather than computers and e-mail to stay in touch, telemedicine programs are taking note of this trend and beginning to rely more on mobile phone technology.

In a multinational prospective study published in the BMJ, investigators demonstrated that parenteral medication errors are common occurrences in intensive care units (ICUs), but the number of errors can be reduced through the use of error-reporting and electronic prescribing systems.

In a pilot study published in the Journal of the American Medical Association, investigators demonstrated that modafinil blocks dopamine transporters and increases dopamine levels in the brain, suggesting that this agent has the potential for abuse and addiction.

The headlines about contaminated heparin and tainted peanuts have put pressure on FDA to improve its methods for detecting unsafe medical and food products and to take swift action when problems emerge. The complaints are prompting the Obama administration to provide more resources for FDA while Congress weighs expanding agency operations and enforcement authority.

This article reviews the similarities and differences between albuterol (ALB) and levalbuterol (LEV) to provide P&T committees a concise summary of the available literature regarding efficacy, side effects, and cost of these agents.

Generic drugs approved by FDA (through April 2009) including malathion lotion, 0.5%

Clevidipine is an intravenous (IV) dihydropyridine calcium-channel blocker (CCB) that is approved for the reduction of blood pressure (BP) when oral therapy is not feasible or not desirable. Clevidipine is effective at reducing BP in the emergency room (ER), intensive care unit (ICU), and in the pre-, peri-, and postoperative settings.