Formulary Watch |

FDA expands use of rivaroxaban to treat, reduce recurrence of DVT, PE

FDA has expanded the approved use of oral anticoagulant rivaroxaban (Xarelto, Janssen) for to include 3 new indications including treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.

FDA: Pradaxa bleeding no higher than warfarin

Bleeding rates associated with new use of dabigatran (Pradaxa, Boehringer Ingelheim) do not appear to be higher than bleeding rates associated with new use of warfarin, according to an FDA safety review of post-market reports of serious bleeding events.

Bacterial contamination of 2 different NECC products confirmed

Two recalled products manufactured by the New England Compounding Center (NECC), Farmingham, Mass., have tested positive for bacterial contamination, according to an FDA update.

State Boards of Pharmacy are lax in regulating compounding pharmacies, congressional report says

The state Boards of Pharmacy have been lax in regulating the practices of compounding pharmacies, like the New England Community Center, Framingham, Mass., implicated in the fungal meningitis outbreak. Instead, most of their enforcement actions have concentrated on compliance with traditional pharmacy licensing, controlled substances, and other requirements, according to a congressional report issued Oct. 29 by Rep. Edward J. Markey (D-Mass.).

Markey legislation to strengthen federal oversight of compounding pharmacies

Congressman Edward J. Markey (D-Mass.) plans to introduce legislation that he believes will strengthen FDA's authority to oversee compounding pharmacies. The New England Compounding Center, located in Rep. Markey's congressional district, is the source of contaminated injectable steroids that led to a national meningitis outbreak, claiming 28 lives and sickening more than 300 people in 19 states, according to a press statement from Markey's office.

Ameridose voluntarily recalls products

Ameridose, LLC, is voluntarily recalling all of its unexpired products in circulation, according to an FDA press release Oct. 31. Ameridose, based in Westborough, Mass., is managed by the same parties that manage the New England Compounding Center (NECC), of Framingham, Mass. Injectable drugs produced by NECC are linked to the fungal meningitis outbreak, which has resulted in 377 fungal meningitis cases, 9 cases of peripheral joint infections and 29 deaths.

In real-world study, benefits outweigh risk for restarting warfarin after initial GI bleed

Patients taking long-term warfarin who had GI bleeding should probably resume warfarin once the bleeding episode is under control to reduce their risk of thrombosis.

Pipeline Preview

Recent FDA action (through October 2012) related to, Treprostinil diethanolamine extended release tablets, Lomitapide, Mipomersen sodium, Xilonix, Ponatinib, Trospium chloride extended-release capsules

Bariatric surgery associated with reduction in the incidence of type 2 diabetes

Bariatric surgery reduces the incidence of type 2 diabetes, according to a recent observational study.

Dimethyl fumarate: A fumaric acid ester under investigation for treatment of relapsing-remitting multiple sclerosis

Dimethyl fumarate is an investigational drug being studied for the treatment of relapsing-remitting multiple sclerosis (RRMS).

FDA warns of serious blood disorder resulting from abuse of Opana ER

FDA has warned patients of TTP, a serious blood disorder that results from misuse of Opana ER.

Truvada (Emtricitabine/tenofovir disoproxil fumarate tablets)

New combination: FDA approved the combination tablet of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (Truvada, Gilead Sciences) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV-1 in adults at high-risk in combination with safer sex practices.

FDA Actions in Brief October 2012

Recent FDA Approvals (through October 2012) related to (Perampanel, Eisai, Ocriplasmin, ThromboGenics, Paclitaxel protein-bound particles for injectable suspension, Celgene, tocilizumab, Genentech, Cysteamine ophthalmic solution, Sigma-Tau Pharmaceuticals, APTIMA HPV 16 18/45 Genotype Assay, Hologic, Adalimumab, Abbott, Regorafenib, Bayer HealthCare, Onyx)

New healthcare payment models to shape drug coverage, costs, and expenditures

Health system payment reform is on the minds of just about everyone involved in healthcare delivery, financing, and analysis.

From the European Society for Medical Oncology 2012 Congress: Additional safety, tolerability data for tivozanib versus sorafenib in metastatic RCC shows fewer adverse events

New data demonstrating the safety and tolerability profile of tivozanib versus sorafenib in the first-line setting for patients with metastatic renal cell carcinoma (RCC), was presented at ESMO's 2012 Congress.

Pharmacists must prioritize medication reconciliation

Although general guidance exists for medication reconciliation, there is a need for more thorough studies and stronger guidelines.

Depressive symptoms are associated with opioid misuse in patients treated with chronic opioids

Depressive symptoms are associated with use of opioids for non-pain symptoms, according to researchers

Wide variation exists in antibiotic prescribing for Medicare patients based on geography, season

A study of Medicare data suggests there is substantial variation in the use of antibiotics across regions after adjusting for population characteristics.

Improve formulary adherence through effective provider engagement

The world of formulary management is changing and organizations must work on education initiatives.

ICUs vary in surveillance, infection-control practices of multidrug-resistant organisms

Screening practices for multidrug-resistant organisms (MDROs) in intensive care units (ICUs) vary widely from hospital to hospital, according to a study published in October.

Disease-modifying therapies for multiple sclerosis: Focus on future direction

Multiple sclerosis (MS) is a neurologic disorder of chronic inflammation and demyelination of the central nervous system. Several additional agents, including oral products, are now under investigation for the future treatment of MS.

Vascepa (Icosapent ethyl)

New molecular entity: FDA approved icosapent ethyl (Vascepa, Amarin Pharmaceuticals Ireland Limited), an ethyl ester of eicosapentaenoic acid (EPA), as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia.

Discontinuation of warfarin therapy higher than generally anticipated

Among older adults with atrial fibrillation (AF), persistence with warfarin therapy is generally lower than what has been reported in clinical trials, according study online in Archives of Internal Medicine.

FDA approves Synribo for chronic myelogenous leukemia

FDA has approved omacetaxine mepesuccinate (Synribo, Teva) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. An estimated 5,430 people will be diagnosed with CML in 2012, according to the National Institutes of Health. Synribo is intended to be used in patients whose cancer progressed after treatment with at least 2 drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML.

Combination of folic acid, vitamin B has no effect on colorectal adenoma

Long-term treatment of folic acid and vitamin B6 and vitamin12 had no statistically significant effect on colorectal adenoma among women who were at high risk for cardiovascular disease, according to recent study published in the Journal of the National Cancer Institute.

Consider financial context of medication adherence, possession

Half of the 3.2 billion prescriptions dispensed annually are not taken as prescribed. Pharmacy benefit leaders must reconsider the financial context of medication adherence and medication possession, according to industry leaders presenting at an online seminar for the Pharmacy Benefit Management Institute in October.

Drug-related problems account for higher hospitalization rate in cardiac transplant patients than the general population

Cardiac transplant patients may be at a higher risk for hospitalization due to drug-related problems than the general population, according to the results from a single cardiac transplant center, published the October issue of The Annals of Pharmacotherapy.

ACIP recommends bacterial meningitis vaccine for at-risk infants

The Advisory Committee for Immunization Practices (ACIP) voted to recommend the use of Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (MenHibrix, GlaxoSmithKline) in infants at increased risk for bacterial meningitis.

Mass. DPH finds multiple health, safety violations at NECC

Numerous health and safety violations related to the practice of pharmacy at the New England Compounding Center (NECC), Framingham, Mass. have been documented by investigators of the Massachusetts Department of Public Health (DPH), according to Madeleine Biondolillo, MD, in a press conference Oct. 23

Investigational drugs to be studied for preventing Alzheimer's

Three investigational drugs will be studied in a worldwide clinical trial to determine whether they can prevent Alzheimer’s disease. In people with inherited mutations that cause early-onset Alzheimer’s, the study will seek to identify whether the drugs can improve Alzheimer’s disease biomarkers and prevent the loss of cognitive function.