The human toll of the New England Compounding Center (NECC) tragedy continues to grow as the death count is at 50 and the number of patients sickened now exceeds 722. These cases have been reported, and are being tracked by the Centers for Disease Control (CDC) in 20 states. The impact that this sequence of events has had, is having, and will continue to have on the practice of pharmacy nationwide is of unprecedented magnitude and is of the utmost concern to practicing pharmacists everywhere.
Nesina: a new dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes as an adjunct to diet and exercise. Oseni: a fixed-dose combination of alogliptin and pioglitazone. Kazano: a fixed-dose combination of alogliptin and metformin HCl
Recent advances in the treatment of metastatic castration-resistant prostate cancer CRPC) have led to new agents demonstrating overall survival (OS) advantages, including autologous cellular immunotherapy (sipuleucel-T), a new taxane (cabazitaxel), 2 therapies further targeting the androgen axis (abiraterone acetate and enzalutamide), and a bone-seeking alpha emitter (radium-223 chloride). This brief review discusses recent clinical trials utilizing the 2 FDA-approved taxanes that were presented at the 2013 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncologists (ASCO), American Society for Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO).
Although patients with rheumatoid arthritis (RA) have a disproportionately higher incidence of herpes zoster, an analysis that included nearly 60,000 patients with RA and other inflammatory diseases found that those who initiated anti-tumor necrosis factor (TNF) therapies were not at higher risk of herpes zoster compared with patients who initiated nonbiologic treatment regimens, according to a study appearing in the March 6 issue of JAMA.
Obesity has become a highly prevalent chronic condition that is associated with significant morbidity and mortality. Studies have demonstrated that even as little as 5% to 10% of weight loss is associated with an improvement in cardiovascular risk factors and a reduction in the incidence of type 2 diabetes in high-risk patients. Prior to the recent approval of lorcaserin and extended-release phentermine/topiramate, there had been no new pharmacologic agents approved for the treatment of obesity for 13 years. This article reviews the pharmacologic treatment of obesity including past treatment options, lessons learned in recent years, current short- and long-term treatment options, and future direction. Formulary considerations of currently available agents are discussed.
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released new regulations about the reporting of fees, meals, travel expenses, and other transfers of value for the implementation of the Physician Payment Sunshine Act (PPSA). These new regulations require that data on the payments and gifts that drug and medical device companies make to physicians will become available publicly in a searchable database beginning in September 2014.1
Patients with type 2 diabetes achieved 6% weight loss with liraglutide 3 mg in a phase 3a obesity trial, according to Novo Nordisk.
Diabetes drugs including exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto) are being evaluated by FDA for a potential link to pancreatitis and precancerous changes of the pancreas.
Long-term treatment with fixed-combination budesonide/formoterol (Symbicort Turbuhaler, AstraZeneca) was associated with fewer healthcare utilization-defined exacerbations and hospitalizations than fluticasone/salmeterol in patients with moderate and severe chronic obstructive pulmonary disease (COPD), according to a study published online in the Journal of Internal Medicine.
Complete response letters; recommendation for approval; fast-track designations; orphan drug designations; first-time generic approvals; FDA actions in brief
Tivozanib and sorafenib extended survival in advanced renal cell carcinoma (RCC) patients with no statistical difference, according to the phase 3 TIVO-1 (TIvozanib Versus sOrafenib in 1st Line Advanced RCC) trial data, presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), in Orlando, Fla., in February.
FDA has approved rabeprazole sodium (AcipHex Sprinkle, Eisai) Delayed-Release capsules 5 mg and 10 mg for the treatment of gastroesophageal reflux disease (GERD) in children ages 1 to 11 years of age for up to 12 weeks.
FDA approved dimethyl fumarate (Tecfidera, Biogen Idec) capsules for the treatment of adults with relapsing forms of multiple sclerosis (MS), including the most common form, relapsing-remitting multiple sclerosis (RRMS), according to an FDA statement on March 27.
FDA approved tobramycin inhalation powder (TOBI Podhaler, Novartis) for the management of cystic fibrosis patients with Pseudomonas aeruginosa), a bacterium that causes lung infections.
Managed care and hospital decision-makers should consider that biological drugs are different from traditional drugs in terms of their complexity and there is potential for problems to arise when manufacturing is not strictly controlled. Furthermore, biological medicines are more difficult to characterize, produce, and reproduce than most traditional pharmaceuticals. This, in turn, can affect the medicine’s quality, safety, or efficacy, and can ultimately impact the reliability of supply, according to a presentation at the Hematology/Oncology Pharmacy Association’s annual conference in Los Angeles, in March.
Patients with type 2 diabetes achieved 6% weight loss with liraglutide 3 mg in a phase 3a obesity trial, according to Novo Nordisk.
The Academy of Managed Care Pharmacy (AMCP) is urging US House leaders to consider a number of proposals to rein in federal spending on healthcare without compromising the popular programs of Medicare and Medicaid.
Med Prep Consulting, Inc., a compounding pharmacy in Tinton Falls, NJ, is voluntarily recalling all lots of compounded products from its facility for fear of mold contamination, according to an FDA press release.
Diabetes drugs including exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto) are being evaluated by FDA for a potential link to pancreatitis and precancerous changes of the pancreas.
FDA approved (technetium Tc 99m tilmanocept (Lymphoseek, Navidea Biopharmaceuticals) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.
The use of extended-release niacin as an adjunct to statins does not reduce the risk of a heart attack or stroke in patients with pre-existing cardiovascular disease, according to researchers who led the HPS2-THRIVE study. The results of the study were reported at the American College of Cardiology conference in San Francisco on March 9.
After receiving input from more than 80 institutions across the United States, the American Society of Health Systems Pharmacists (ASHP) and the American Pharmacists Association (APhA) developed a new medication management care transition guide.
FDA is warning the public that azithromycin (Zithromax or Zmax; Pfizer) can cause abnormal changes in the electrical activity of the heart that may lead to potentially fatal cardiac arrhythmias.
Almost 98% of primary care physicians (PCPs), nurse practitioners, and pharmacists trust and recommend over-the-counter (OTC) medicines to their patients, according to a new survey released by the Consumer Healthcare Products Association (CHPA).
FDA has approved aripiprazole (Abilify Maintena, Otsuka and Lundbeck) for extended-release injectable suspension for the treatment of schizophrenia.
