Formulary Watch |

FDA: Slightly elevated risk of cardiovascular, cerebrovascular issues with Xolair

An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug omalizumab (Xolair, Genentech) than in those who were not treated with omalizumab. As a result, FDA has added information about these potential risks to the drug label.

FDA approves updated label changes for Chantix

FDA has approved updated label changes for the smoking cessation drug, varenicline (Chantix, Pfizer).

Humira receives FDA approval for treating pediatric patients with Crohn’s disease

FDA has approved adalimubab (Humira, AbbVie) to treat pediatric patients with moderate to severe Crohn’s disease.

Pulmonary Fibrosis patient survey highlights quality of life issues

The Pulmonary Fibrosis Foundation (PFF) submitted survey data from more than 1,100 patients and families suffering from pulmonary fibrosis (PF) to the U.S. Food and Drug Administration (FDA). Read more about the survey data to better understand the unique needs of patients and families with IPF.

Otezla approved for plaque psoriasis

FDA has approved Otezla (apremilast, Celgene) for treating moderate-to-severe plaque psoriasis in patients who are considered candidates for systemic therapy or phototherapy.

Glucose monitoring system cleared for use in hospital critical care units

Underpinning FDA clearance were data gathered from a study of more than 1650 patients with a variety of medical conditions and medications who were being treated in different hospital departments like cardiac, emergency intensive care, and surgical departments. In all of the various types of patients being tested, study results found agreement in blood glucose results versus a comparator laboratory glucose analyzer.

Study: Patients have better health outcomes with generic statins as opposed to brand-name statins

Initiating statin therapy with a generic instead of a brand-name version was associated with lower out-of-pocket spending, better medication adherence, and better health outcomes, according to a study published recently in the Annals of Internal Medicine.

CVS: Expansion of MinuteClinics to offset tobacco revenue loss

In an increasing effort to continue to play a complementary role with primary care practices in providing care to patients, CVS Health has worked to deplete existing cigarette inventory at CVS/pharmacy stores without receiving new shipments.

Revitalizing stagnant sepsis pipeline requires targeting niche patient populations, with premium pricing likely justified

lthough the growing public outcry surrounding antibiotic resistance has only recently propelled sepsis back into the international spotlight, in reality, the sepsis marketplace has been one of high unmet medical need for decades. The condition, which currently lacks specific therapies beyond antimicrobials and basic supportive care, has quietly evolved into one of the most urgent medical issues facing our healthcare system today

Oral vancomycin can help prevent recurrent C difficile infections

Oral vancomycin (Vancocin) prophylaxis may be effective for the prevention of recurrent Clostridium difficile infection with minimal risk to the patient, according to a poster presentation at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

New type 2 diabetes drug approved by FDA

FDA has approved Trulicity (dulaglutide, Eli Lilly) to treat type 2 diabetes mellitus.

New data examines sustained glycemic control with exenatide once weekly vs. insulin glargine

Post-hoc analysis found that, despite continued titration with insulin glargine, more diabetes patients achieved sustained glycemic control with exenatide once-weekly, according to data presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria.

Study: Dapagliflozin with metformin shows blood sugar reductions vs. glipizide

Four-year data from a phase 3 study examined the durability of glycemic response with dapagliflozin as add-on therapy to metformin vs. glipizide in patients with type 2 diabetes inadequately controlled with metformin alone. The data was presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria.

Insulin degludec/insulin aspart offers good glycemic control with fewer injections than basal-bolus regimen

Insulin degludec/insulin aspart (Ryzodeg, Novo Nordisk) administered twice daily, provides successful glycemic control with fewer injections than a basal-bolus regimen, according to data presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria.

Antibiotics prescribed unnecessarily in kids, more antimicrobial stewardship needed

As many as 11.4 million antibiotic prescriptions written each year for children and teens may be unnecessary, according to a study in the October 2014 issue of Pediatrics, published online Sept. 15.

FDA committee recommends approval for liraglutide as anti-obesity drug

Liraglutide 3 mg (Saxenda, Novo Nordisk) has been recommended by an FDA Advisory Committee to be approved for use in the treatment of obesity

New drug approved by FDA for treatment of opioid-induced constipation

FDA has approved a new treatment option for opioid-induced constipation in adult patients with chronic noncancer pain. Naloxegol (Movantik, AstraZeneca) tablets C-II is the first once-daily, oral, peripherally acting µ-opioid receptor antagonist (PAMORA) to be approved for this condition.

Respiratory virus Enterovirus D68 hits hardest in kids with asthma

About 1,000 cases of the respiratory illness caused by Enterovirus D68 have been confirmed in 10 states in the United States so far. Many of these children are being hospitalized for it.

FDA approval given for new drug to treat obesity

FDA has approved a combination of the generic drugs naltrexone and bupropion (Contrave) for chronic weight management in obese adults (body mass index [BMI] >30 kg/m2). This combination agent has also been approved for use in those patients who are overweight (BMI >27 kg/m2) and have at least one weight-related comorbid condition such as diabetes, hypertension, or dyslipidemia.

[BLOG]: Medications are the new battlefield and pharmacists are the best “recon” agents

Medication-related problems (MRPs) can be a significant patient safety risk, particularly in hospitalized patients. One method used to minimize this safety concern is through medication reconciliation, or the process of documentation of a patient’s outpatient medication list at the time of hospital admission. Medication reconciliation can be performed by any trained health care professional (i.e. nurses, pharmacy technicians, physicians, etc.), however improved patient safety outcomes have been demonstrated when pharmacists perform this process.

Patient access to orphan drugs faces new set of challenges

In 1983, the United States enacted the Orphan Drug Act (ODA). An analogous law was passed in Europe in 2000. Both pieces of legislation are considered major successes in terms of spurring the development of orphan drugs. To illustrate, in the decade prior to 1983 only 34 orphan products were marketed, whereas in the past year alone 9 orphan drugs were launched. In the past 5 years, 39 orphan drugs were launched in the US across numerous therapeutic categories, including multiple myeloma, chronic myeloid leukemia, metastatic non-small cell lung cancer, hemophilia, tuberculosis, homozygous familial hypercholesterolemia, and cystic fibrosis.1

Study: Patients with advanced dementia continue receiving inappropriate medications

Nursing home residents with advanced dementia often receive medications of questionable benefit with costly consequences, according to a study published online September 8 in the Journal of the American Medical Association Internal Medicine.

FDA approves oral iron-based treatment for dialysis patients with hyperphosphatemia

FDA has approved Ferric Citrate (Keryx), an oral, iron-based therapy for the control of serum phosphorus levels in chronic kidney disease (CKD) patients on dialysis.

Investigational oral formulation of hydrocodone, acetaminophen shows efficacy in phase 3 acute pain trial

An investigational extended-release oral formulation of hydrocodone and acetaminophen the treatment of moderate to moderately severe acute pain was more effective than placebo at providing rapid and consistent pain relief in patients 48-hours post-surgery, according to a recent data presented at PAINWeek 2014 in Las Vegas.

Experience Brief: Femoral nerve block reduces hospital admissions, opioids in pediatrics

Nationwide Children’s Hospital is one of 13 medical centers nationwide participating in the Pediatric Regional Anesthesia Network, a collaboration designed to support the collection of highly audited data on practice patterns and complications and to facilitate collaborative research in regional anesthetic techniques in infants and children. Participating institutions report the number of regional anesthesia procedures they do each month. Researchers conducted this study at Nationwide Children’s Hospital in Columbus, Ohio, publishing its results in the Journal of Pediatric Orthopaedics in June.

USPSTF recommends low-dose aspirin for women at high risk for preeclampsia

The US Preventive Services Task Force (USPSTF) published a final recommendation statement recommending that women at high risk for preeclampsia use low-dose aspirin (81 mg/day) after 12 weeks of pregnancy to prevent the condition and its related health problems.

FDA drug approvals-September 2014

FDA actions in brief, fast-track designations, priority review, orphan drug designations

Drugs in Perspective: Dalvance

Dalvance (dalbavancin) is the first and only intravenous antibiotic was approved on May 2014 to treat ABSSSIs with a 2-dose regimen of 1,000 mg once week and later on a 500 mg that is given over a 30-minute time span

Investigational heart failure drug cut cardiovascular deaths by 20% vs. ACE-inhibitor in study

Patients with heart failure and reduced ejection fraction (HF-REF) treated with an investigational angiotensin receptor neprilysin Inhibitor (ARNI) are more likely to reduce cardiovascular death and heart failure hospitalization than those given ACE inhibitors or ARBs as first-line therapy in heart failure, according to data presented at the European Society of Cardiology congress in Barcelona, Spain, and published simultaneously in the New England Journal of Medicine.

FDA approves Keytruda for advanced melanoma

FDA has approved pembrolizumab (Keytruda, Merck) for treatment of patients with advanced or unresetable melanoma who are no longer responding to other drugs.