Formulary Watch |

FDA warns consumers about OTC homeopathic asthma treatments

The FDA warns consumers not to rely on the use of over-the-counter homeopathic therapies for the treatment of asthma. Without appropriate management, asthma could lead to a life-threatening asthma attack. Homeopathic remedies have not be evaluated by the FDA and may interfere with asthma management.

[BLOG]: FDA approves first biosimilar in US, may lead to easier access to biologic medications for patients

In this guest blog post, Larry LaMotte, spokesperson for Patients for Biologics Safety & Access and Vice President of Public Policy at the Immune Deficiency Foundation, discusses the possibility of biosimilars helping increase access to vital medications for patients with chronic and life-threatening conditions.

New dose of Viibryd approved to treat major depressive disorder in adults

FDA has approved a new dose of vilazodone (Viibryd, Actavis) for the treatment of Major Depressive Disorder (MDD) in adults.

Study: Genetic variants determine whether aspirin/NSAIDS will reduce colorectal cancer risk

Regular use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) appears to reduce the risk of colorectal cancer in most individuals, but a few individuals with rare genetic variants do not share this benefit, according to a study published in the March 17 issue of JAMA.

[BLOG]: Best Practices between formulary managers and pharmacists to address challenges in COPD readmissions

To address the burden of COPD on hospital expenditures, on October 1, 2014, the Centers for Medicare & Medicaid Services included COPD in its Hospital Readmissions Reductions Program. This inclusion resulted in reduced Medicare reimbursement for hospitals that demonstrate excessive 30-day COPD patient readmission rates.

FDA approves drug to treat rare bile acid synthesis disorders in kids, adults

FDA approved its first treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

DEA issues alert on fentanyl after overdoses

The United States Drug Enforcement Administration (DEA) on March 18 issued a nationwide alert about the dangers of fentanyl and fentanyl analogues/compounds.

Drugs in Perspective: Lemtrada (alemtuzumab)

Lemtrada (alemtuzumab) received FDA approval on November 14, 2014, under fast track designation, for the treatment of patients with relapsing forms of MS.Due to the safety profile, alemtuzumab should generally be reserved for patients who have had an inadequate response to 2 or more drugs indicated for MS.

First atypical antipsychotic approved for pediatric patients with bipolar I disorder in 5 years

FDA has approved asenapine (Saphris, Actavis) for treatment of manic or mixed episodes of bipolar I disorder in pediatric patients, ages 10 to 17 years old.

Investigational PCSK9 inhibitor lowers LDL-C, may reduce cardiovascular events

Alirocumab (Praluent), a PCSK9 inhibitor, reduced low-density lipoprotein (LDL) cholesterol levels in patients who are receiving statin therapy, according to a study published online in the New England Journal of Medicine.

GAO: Antipsychotic overuse “widespread” for dementia

There is widespread overuse of psychiatric drugs by older Americans with Alzheimer’s disease or dementia who live at home or in assisted living facilities, according to a new General Accountability Office (GAO) report.

Takeda announces post hoc analysis of data from EXAMINE cardiovascular safety outcomes trial

In patients with type 2 diabetes and recent acute coronary syndrome (ACS), dipeptidyl peptidase 4 (DPP-4) inhibitor alogliptin compared to placebo did not increase the risk of heart failure (HF) outcomes, according to data published in The Lancet.

IPF survival rates better in double-lung transplantation

Double-lung transplantation in patients with idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD) was associated with better graft survival and patient survival than single-lung transplantation, according to a JAMA study.

FDA opens up generic competition

FDA released new draft guidance designed to make it easier for generic manufacturers to introduce competition to 38 existing drug products, according to the agency’s Federal Register notice.

FDA updates Chantix label to include possible alcohol interaction

FDA has warned that the smoking cessation drug varenicline (Chantix) can interact with alcohol, resulting in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia.

Biosimilar drugs could save US billions

FDA's approval of the “generic" biologic prescription version of cancer medicine Neupogen opens the door to a movement that could save the US healthcare system tens of billions of dollars a year, according to Forbes.

Sepsis patients return to hospital for preventable reasons; better post care needed

Better post-hospital care is needed for sepsis patients to avoid readmissions that drive up costs and interfere with recovery, according to a study published in the March 10 issue of JAMA.

Anticholinergic drugs linked to higher risk for pneumonia in elderly

Taking commonly used medications with anticholinergic effects is associated with a significantly higher risk for developing pneumonia, according to a study published recently in the Journal of the American Geriatrics Society.

First therapy for pediatric high-risk neuroblastoma approved by FDA

FDA approved dinutuximab (Unituxin, United Therapeutics) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.

FDA drug approvals-March 2015

FDA actions in brief, breakthrough designation, recommended for approval, priority review, fast-track designations

FDA approves first biosimiar Zarxio

FDA approved filgrastim-sndz (Zarxio, Sandoz), the first biosimilar product approved in the United States.

Paracetamol: Is it as safe as we thought?

Paracetamol (acetaminophen) is still safer than nonsteroidal anti-inflammatory drugs (NSAIDs), but there is concern about its potential for some side effects not usually considered related to paracetamol, according to a study published in the Annals of Rheumatic Diseases.

New antifungal drug approved by FDA

Cresemba (isavuconazonium sulfate, Astellas Pharma US) has just been approved by FDA for the treatment of adults suffering from the rare but serious infections of invasive aspergillosis and invasive mucormycosis. Individuals with weakened immune systems are most prone to these infections.

Corticosteroids recommended for severe pneumonia

Because the use of corticosteroids in patients with severe community-acquired pneumonia is controversial, researchers in Spain set out to determine the benefits versus the pitfalls of using the adjunctive therapy.

Fondaparinux beats heparin in major study

The anticoagulant medication Fondaparinux (Arixtra) was associated with reduced major bleeding events and improved survival, compared to low-molecular-weight heparin (LMWH) in a large randomized clinical trial involving patients with non–ST-segment elevation myocardial infarction (NSTEMI), according to a new study.

FDA issues new labeling indications for testosterone replacement therapy

FDA has issued new labeling indications for prescription testosterone replacement therapy (TRT) in order to clarify that it is not indicated for men who have a normal age-related decline in testosterone. The new labeling also will provide warnings on the risk of cardiovascular injuries that may occur with the use of TRT.

FDA approves additional indication for Opdivo

FDA has expanded the approved use of nivolumab (Opdivo, Bristol Myers Squibb) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Drug shortages mobile app launched by FDA

FDA has launched its first mobile application (app) designed to provide quick access to important information on medications that are in short supply. Current or resolved drug shortages, as well as product discontinuations, can be identified by using the new app.

New device prevents cancer tumors from coming back

A new nanodevice developed by MIT researchers can help prevent cancer tumors from growing back after chemotherapy, according to a new study published in the Proceedings of the National Academy of Sciences for the week of March 2.

Hospital pharmacists protest higher cancer drug costs in survey

A national survey of pharmacy professionals released March 3 found that a move to specialty drug distribution of three primary cancer drugs is resulting in higher costs to hospitals and reduced availability of the medications.