Formulary Watch |

Testosterone products: FDA requires beefed up labeling to include risk of VTE, including DVT, PE

FDA is requiring manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).

SSRIs in pregnancy not linked to cardiac defects in babies

In pregnancy, first trimester use of antidepressants does not substantively increase the risk of specific cardiac defects in babies, and should not be an important consideration in the treatment decision, according to a study published in the June 19 issue of the New England Journal of Medicine.

Study: Topiramate XR improves seizure control in epilepsy patients

An extended-release formulation of topiramate (Qudexy XR, Upsher-Smith Laboratories) has been shown to be sale and effective in refractory epilepsy patients in a global phase 3 clinical trial.

ADA: Study says non-insulin dulaglutide demonstrates effective blood glucose control in diabetes patients

American Diabetes Association Scientific Sessions in San Francisco, showed that investigational, non-insulin, once-weekly dulaglutide 1.5 mg provided significant blood glucose control for patients with type 2 diabetes.

EULAR: Sarilumab investigational anti-IL-6R therapy shows positive results in rheumatoid arthritis treatment in study

Sanofi and Regeneron Pharmaceuticals presented positive results from a phase 3 trial of investigational drug sarilumab in rheumatoid arthritis (RA) patients who were inadequate responders to methotrexate (MTX) therapy at the European League Against Rheumatism Annual Congress (EULAR 2014) Congress in Paris, France.

ADA: Studies point to safety, efficacy profile for new insulin glargine product

LY2963016 insulin glargine has a similar safety and efficacy profile to currently marketed insulin glargine, according to data recently presented the American Diabetes Association (ADA) Scientific Sessions in San Francisco.

ADA: Empagliflozin versus placebo controlled patients with type 2 diabetes on multiple daily insulin injections

In a 52-week study of obese adults with type 2 diabetes on high insulin doses with or without metformin, adding empagliflozin to multiple daily insulin injections significantly reduced blood glucose and body weight with lower insulin doses compared with placebo, according to data recently presented at the American Diabetes Association (ADA) Scientific Sessions in San Francisco.

ADA: Empagliflozin added to metformin showed greater reductions in blood glucose, body weight versus glimepiride

In a 2-year study, empagliflozin as add-on to metformin demonstrated significantly greater decreases in hemoglobin A1c (a measure of average blood glucose over the past 2 to 3 months), body weight and blood pressure compared with glimepiride as add-on to metformin in adults with type 2 diabetes.

Whooping cough in California reaches epidemic proportions

A pertussis (whooping cough) epidemic has been declared in California, according to the California Department of Public Health (CDPH).

ASCO: Ipilimumab improves recurrence-free survival in melanoma

Ipilimumab (Yervoy, Bristol-Myers Squibb) significantly improved recurrence-free survival in patients with stage 3 melanoma in the adjuvant setting, compared to placebo, according to data presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

ADA: Canola oil can help control blood glucose in people with type 2 diabetes

Unhydrogenated, unsaturated vegetable oils, such as canola oil, can have health advantages when included in as part of a low-glycemic index (GI) diet in people with type 2 diabetes, according to research presented at American Diabetes Association Scientific Sessions in San Francisco, and published in Diabetes Care.

Rotavirus vaccine reduces hospitalization, cuts costs

The introduction of rotavirus vaccines has substantially reduced the healthcare utilization related to diarrhea in children residing in the United States, according to a new study published in Pediatrics.

Rivaroxaban alternative option for elderly

Rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals) may be used as an alternative to warfarin in older patients with atrial fibrillation.

Is a Hep C drug price war headed our way?

FDA has granted priority review for AbbVie’s investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection.

Joint Commission raises awareness of unsafe injection practices

To raise awareness of the prevalence of unsafe injection practices, the Joint Commission has issued a Sentinel Event Alert to educate healthcare organizations and healthcare workers on the risks of misusing vials of injectable medical products.

Chronic hep C: More effective, better-tolerated therapies still needed, researchers say

Future therapies for chronic hepatitis C that have greater tolerability, simplified dosing schedules, shorter treatment duration, and more favorable safety profiles are needed to improve adherence and enhance treatment effectiveness, according to an abstract published in Value in Health. Treatments with fewer contraindications are also needed to expand available treatments to more patients in need of effective therapy.

Metformin controls blood sugar more effectively in African Americans: Study

African Americans taking the diabetes drug metformin saw greater improvements in their blood sugar control than white patients who were prescribed the same medication, according to a study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism (JCEM).

5 ways to manage sepsis

Sepsis or “severe infection” has returned as a major cause of death in inpatients, and disability among survivors, according to a new issue brief from the Center for Healthcare Research & Transformation (CHRT).

FDA approves first hemophilia A drug to extend interval between prophylactic infusions in adults and children

FDA has approved Antihemophilic Factor (Recombinant), Fc Fusion Protein (Eloctate, Biogen Idec) for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A.

Drugs in Perspective: Zohydro ER (hydrocodone bitartrate extended release)

Pain management is gradually becoming a topic of conversation and gaining considerable attention as it relates to providing quality services for those with acute or chronic pain ailments. Pain can affect millions of Americans and it contributes significantly to national rates of morbidity, mortality, and disability.

Study bolsters support of ibrutinib as second-line therapy in CLL treatment

Ibrutinib (Imbruvica) outperformed ofatumumab as a second-line therapy, for the treatment of relapsed chronic lymphocytic leukemia (CLL), according to a multicenter interim study published in the OnLine First edition of the New England Journal of Medicine.

Cigna uses predictive risk modeling to identify patients likely to benefit from aggressive LDL-C lowering statin treatment

In a move that is intended to foster access to cholesterol-lowering therapy for patients who will best benefit, Cigna has entered into a first-of-its-kind contract with AstraZeneca to help ensure that patients are given an appropriate cholesterol-lowering medication based on their treatment needs.

Merck to boost hep C drug portfolio with Idenix purchase

The acquisition of biopharmaceutical company Idenix Pharmaceuticals by Merck exemplifies the strong market opportunity in the hepatitis C market, according to industry watchers.

ASCO: Second-line treatment with ramucirumab with standard docetaxel extends survival in NSCLC

Ramucirumab (Cyramza) combined with docetaxel (Taxotere) extended overall survival 1.4 months in patients with non-small cell lung cancer (NSCLC) when compared to standard second-line therapy (Taxotere alone), according to data presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

ASCO: Bortezomib-based regimen shows improved outcomes for mantle cell lymphoma

A bortezomib (Velcade)-based regimen significantly improved progression free survival (PFS) and consistently improved secondary efficacy end points in previously untreated mantle cell lymphoma (MCL) patients compared to standard therapy, according to data presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

ASCO: Ceritinib shrank tumors in most patients with ALK+ NSCLC regardless of prior ALK treatment

Ceritinib (Zykadia) previously known as LDK378,shrank tumors in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC), including those who had received previous treatment with an ALK inhibitor as well as patients receiving one for the first time, according to data presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. Results were also observed in patients with ALK+ NSCLC who entered the study with brain metastases.

Pneumonia patients treated with azithromycin had lower risk of death, small increased risk of heart attack

In older adults hospitalized with pneumonia, treatment that included azithromycin compared with other antibiotics was associated with a significantly lower risk of death and a slightly increased risk of heart attack, according to a study in the June 4 issue of JAMA.

Delay in filling clopidogrel prescription after coronary stent linked to adverse clinical outcomes

A delay in filling the first prescription for clopidogrel after coronary stenting is associated with an increased risk of death and myocardial infarction (MI), according to a study published online May 28 in the Journal of the American Heart Association.

[BLOG]: Effective collaboration can help to mitigate drug shortages

Patients across the country continue to feel the impact of critical prescription drug shortages. As formulary managers understand, an integrated approach to solving shortages, involving all supply chain stakeholders, can have a profound effect on mitigating the impact of shortages on patients.

Prescription drug abuse drives heroin use increases among suburban, rural whites

Heroin use has become pervasive in all sectors, inner cities, suburbs and rural areas. It is no longer an isolated problem, according to a study published in JAMA Psychiatry.