Formulary Watch |

FDA approves perampanel as adjunctive treatment for partial-onset seizures in patients with epilepsy aged 12 years and older

FDA has approved perampanel (Fycompa, Eisai), an AMPA receptor antagonist, as an adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients aged 12 years and older who have epilepsy.

Look for meningitis symptoms beyond 6 weeks after contaminated steroid injections

meningitis, steroids, FDA, CDC, compounding

New recommendations issued for pneumococcal vaccine in high-risk adults

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has updated its recommendations for pneumococcal vaccine in high-risk adults.

Screening for those at high risk for T2DM does not reduce mortality within 10 years, study finds

Screening patients who are at high risk for diabetes does not reduce their all-cause, cardiovascular, or diabetes-related mortality within 10 years, according to a study published October 4 in The Lancet.

HRT can reduce risk of heart failure, heart attack in first 10 years following menopause

Women who take HRT for 10 years following menopause have a significantly reduced risk of mortality, heart failure, and heart attack without any increased risk of cancer, DVT, or stroke, a Danish study published on bmj.com showed.

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

FDA has warned patients of thrombotic thrombocytopenic purpura (TTP), a serious blood disorder, resulting from misuse of oxymorphone hydrochloride extended-release tablet (Opana ER, Endo).

FDA confirms specific fungus associated with meningitis outbreak

FDA and the Centers for Disease Control and Prevention (CDC) confirm that the fungus Exserohilum rostratum contaminated 1 of the 3 implicated lots of preservative-free methylprednisolone acetate (80 mg/mL) from the New England Compounding Center (NECC), which the company recalled September 26.

FDA expands use of Actemra for earlier-stage arthritis

FDA has expanded the approved indication for tocilizumab (Actemra, Genentech) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more disease-modifying antirheumatic drugs (DMARDs).

Social value of statins merits actions to broaden treatment, improve adherence, study finds

New evidence suggests that statins generate large survival and health benefits at the population level and shows that the social value of the survival gains are large and go predominantly to consumers, according to a study published in the October issue of Health Affairs.

Intranasal fentanyl spray benefits compared with oral agents for breakthrough cancer pain

Patients with breakthrough cancer pain (BTCP) may want to consider intranasal fentanyl spray over oral agents to treat their breakthrough pain because of improved onset of analgesia and avoidance of nausea and vomiting, according to a report published online for The Annals of Pharmacotherapy.

Resuming warfarin after GIB event decreases risk of thrombosis, death

Patients who experience a warfarin-associated gastrointestinal tract bleeding event should resume anticoagulation therapy during the 90 days following the event to decrease the risk of thrombosis and death, according to a study published online in the Archives of Internal Medicine.

Combination therapy provides rapid sedation for acute agitation in ED

Use of concurrent sedating agents provides rapid sedation and reduces the need for resedation in acutely agitated patients, according to clinical trial results published online in the Annals of Emergency Medicine.

FDA approves therapy for first-line treatment of advanced NSCLC

FDA has approved paclitaxel protein-bound particles for injectable suspension) (albumin-bound) (Abraxane, Celgene) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

First universal medication labeling standards may lead to better adherence

With medication misuse resulting in more than 1 million adverse drug events per year in the United States, new standards released today by the U.S. Pharmacopeia Convention (USP) for the first time, provide a universal approach to the format, appearance, content, and language of instructions for medicines in containers dispensed by pharmacists.

FDA approves cysteamine ophthalmic solution 0.44% for treatment of corneal cystine crystals in cystinosis patients

FDA has approved cysteamine ophthalmic solution (Cystaran, Sigma-Tau Pharmaceuticals) 0.44%, a topical ophthalmic therapeutic, developed in partnership with the National Institutes of Health (NIH), for the treatment of corneal cystine crystal accumulation in patients with cystinosis.

Generic antidepressant taken off the market

After reviewing new data, FDA has concluded that Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories, Inc., and marketed by Teva Pharmaceuticals USA, Inc., is not therapeutically equivalent to GlaxoSmithKline’s Wellbutrin XL 300 mg.

FDA gives green light to ANDA for chewable diabetes tablet

FDA has approved Boston Therapeutic’s petition to file an Abbreviated New Drug Application (ANDA) for a new, chewable tablet formulation of the diabetes drug metformin hydrochloride. The company plans to market the new formulation under the name Pazamet.

Study: Tranexamic acid reduces bleeding deaths, thrombotic events in all trauma patients

Tranexamic acid can safely be used in all trauma patients, not just those who are the most severely injured, according to data analyses results published in the September 11 issue of the British Medical Journal.

Omega-3 fatty acid supplements not helpful for CVD prevention, JAMA reports

Treatment with omega-3 polyunsaturated fatty acides to prevent cardiovascular disease (CVD) has been controversial. A recent meta-analysis and review showed that overall, omega-3 PUFA supplementation did not lower the risk of CVD, according to data published in the Sept. 12, 2012 issues of JAMA.

Long-term use of NSAIDs following MI is risky, study shows

Long-term use of nonsteroidal anti-inflammatory drugs following a first-time myocardial infarction is associated with persistent increased cardiovascular risk, according to an online study published September 24 in the journal Circulation.

FDA fast tracks delafloxacin

FDA has granted delafloxacin (Rib-X) as a Qualified Infectious Disease Product (QIDP) for the indications of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Lower rates of stroke, bleeding seen with apixaban compared to warfarin in Afib patients, regardless of risk profile

Apixaban (Eliquis), an investigational anticoagulant developed by Bristol-Myers Squibb and Pfizer, has lower rates of stroke, systemic embolism, and bleeding than warfarin in patients with atrial fibrillation, regardless of level of risk for these events, according a recent online analysis published October 2 in The Lancet.

Paliperidone palmitate label adds more dosing options, warnings

Paliperidone palmitate (Invega Sustenna), a monthly extended-release injectable suspension atypical antipsychotic for the treatment of schizophrenia, has a new updated product label that describes greater flexibility and dosing options for healthcare providers as well as additional warnings and precautions, according to its manufacturer, Janssen Pharmaceuticals.

Take charge of medication reconciliation to reduce readmission rates

A recent study indicates that hospitals can reduce readmission rates if they work on medication reconciliation.

From the American College of Cardiology Annual Scientific Session & Expo 2012: Modifying antiplatelet therapy based on platelet function testing does not improve outcomes in stroke/TIA patients

In the quest to adopt personalized medicine approaches, optimizing antiplatelet therapy based on platelet function testing is controversial.

Tofacitinib: A novel oral Janus kinase inhibitor for rheumatoid arthritis

Tofacitinib is a novel JAK inhibitor, selective for JAK 1 and JAK 3.

Pipeline Preview

Recent FDA action (through September 2012) related to, Lymphoseek, technetium Tc 99m tilmanocept, Tobramycin inhalation powder, Lixivaptan, CRTX 080, ALV003, AB103, Atox Bio

FDA Actions in Brief September 2012

Recent FDA Approvals (through August 2012) related to (Innocutise, Genzyme, Sanofi, Pfizer, Amgen, Astellas Pharma US, Medivation, Gilead Sciences, Ironwood Pharmaceuticals, Forest, Reckitt Benckiser, Boehringer Ingelheim, Eli Lilly, Sicor Biotech UAB, Teva Corporation, Novartis)

Prepopik (Sodium picosulfate and magnesium oxide and anhydrous citric acid for oral solution)

New molecular entity: FDA approved the combination of sodium picosulfate (a stimulant laxative) and magnesium oxide and anhydrous citric acid (which form magnesium citrate, an osmotic laxative) (Prepopik, Ferring Pharmaceuticals) for cleansing of the colon as a preparation for colonoscopy in adults.

Current standards and future treatments of rheumatoid arthritis

Rheumatoid arthritis is an autoimmune disorder in which the immune system targets synovial joints and causes mild-to-severe joint disease with extra-articular manifestations. This review discusses the current standards of care and details the data being collected on new agents.