Formulary Watch |

FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings

FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.

FDA approves Abstral; REMs enrollment required

FDA has approved fentanyl (Abstral, ProStraken) transmucosal tablets to manage breakthrough pain for adults with cancer.

Physicians welcome dabigatran etexilate as alternative to warfarin

In a guest editorial, 2 researchers highlighted the importance of the FDA approval in October of dabigatran etexilate (Pradaxa, Boehringer Ingelheim), an oral thrombin inhibitor that provides an alternative to warfarin (Coumadin, Bristol-Myers Squibb) for long-term stroke prevention in patients with non-valvular atrial fibrillation.

New 3-drug regimen improves outcomes for myeloma patients

The addition of bortezomib to the standard induction therapy before double autologous stem cell transplantation for patients with multiple myeloma appears to improve nearly threefold the rates of complete or near complete response, according to research published online in The Lancet, HealthDay News reported.

Combining statins and fibrates increases rhabdomyolysis risk

Patients who are newly treated with statin-fibrate concurrent therapy are slightly more likely to be hospitalized with rhabdomyolysis than those who take just one of the medications, according to research published in the American Journal of Cardiology, HealthDay News reported.

Many new cancer drugs require updated safety labels

Many serious or potentially fatal adverse reactions associated with new, targeted anticancer agents are not reported in the original published research on the drug, and they are not known to oncologists until years later when updated drug labels, including boxed warnings, are required, according to research published online in the Journal of Clinical Oncology, HealthDay News reported.

Daily aspirin tied to decreased risk of cancer mortality

Daily aspirin taken for at least 5 years appears to greatly reduce mortality from gastrointestinal and non-gastrointestinal cancers, according to research published online in The Lancet, HealthDay News reported.

Drug Watch: Osteoporosis and related bone disease (PDF) (January 2011)

Agents in late-stage development for the treatment of osteoporosis and related bone disease.

Combination improves human epidermal growth factor receptor 2-positive breast cancer response rates

A combination of lapatinib, trastuzumab, and paclitaxel significantly improved tumor response rates in patients with human epidermal growth factor receptor 2-positive breast cancers, according to a new study presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas.

FDA Pipeline Preview, January 2011 (Ezogabine, Ticagrelor, Naltrexone SR/bupropion, Clostridium difficile vaccine, Elacytarabine, Glycerol phenylbutyrate, Perifosine, Cladribine Tablets, Florbetapir, ALS-AVP-21D9, Cyclosporine, PRX-8066, QLT091001)

Recent FDA action (through, December 2010) related to Ezogabine, Ticagrelor, Naltrexone SR/bupropion, Clostridium difficile vaccine, Elacytarabine, Glycerol phenylbutyrate, Perifosine, Cladribine Tablets, Florbetapir, ALS-AVP-21D9, Cyclosporine, PRX-8066, QLT091001.

Denosumab (Xgeva): A RANK ligand inhibitor

New indication: Denosumab (Xgeva) has been approved for prevention of skeletal-related events from bone metastases from solid tumors.

Early rheumatoid arthritis treatment with rheumatologist improves disease outcomes

Patients with rheumatoid arthritis who are seen by a rheumatologist within 12 weeks of symptom onset were likely to experience less joint destruction and have a higher chance of achieving disease modifying anti-rheumatic drug-free remission, according to a new study published December 2010 in Arthritis & Rheumatism.

New Parkinson's disease pipeline needs to offer improved quality of life, balanced with cost containment

Parkinson's disease, which decreases the amount of dopamine in the brain, affects about 1 million Americans. Available medical therapy cannot modify the progression of the disease; medications have only been shown to alleviate its symptoms.

First-time generic approvals January 2011

Generic drugs approved by FDA (through December 2010): Levocetirizine tablets

Saxagliptin and metformin extended release (Kombiglyze XR): A combination tablet

New combination: Saxagliptin and metformin extended release (Kombiglyze XR) was approved to improve glycemic control in adults with type 2 diabetes mellitus.

Angiotensin receptor blockers may not reduce mortality in diabetes, hypertension settings

Antihypertensive therapy with an angiotensin receptor blocker is not associated with reductions in cardiovascular or all-cause mortality compared to non-ARB-based regimens in patients with type 2 diabetes, according to researchers at the Massachusetts College of Pharmacy and Health Sciences.

FDA Actions in Brief January 2011 (Amturnide, Prezista, Safyral, Gardasil, Atelvia)

Recent FDA Approvals (through December 2010) related to Amturnide, Prezista, Safyral, Gardasil, Atelvia

Adjuvant taxane-based regimen with docetaxel trumps fluorouracil, doxorubicin, and cyclophosphamide for treatment of high-risk, node-negative breast cancer

As compared to fluorouracil, doxorubicin, and cyclophosphamide, an adjuvant taxane-based regimen containing docetaxel, doxorubicin, and cyclophosphamide was shown to increase the rate of disease-free survival by 32% among women with high-risk, node-negative breast cancer.

Protease inhibitor saquinavir linked to QT, PR interval prolongation

FDA is requiring a new warning be added to the prescribing information for saquinavir (Invirase) detailing the drug's potential to prolong both QT and PR intervals on an electrocardiogram, and thus potentially cause the dangerous abnormal heart rhythms called torsades de pointes and complete heart block.

Technosphere insulin: An inhaled mealtime insulin for the treatment of type 1 and type 2 diabetes mellitus

Technosphere insulin is an inhaled form of regular human insulin with a rapid onset of action (~15 min) that is being considered for approval for the treatment of type 1 and type 2 diabetes mellitus. Technosphere insulin has shown efficacy in decreasing the level of glycosylated hemoglobin in a dose-dependent manner.

Pediatric over-the-counter liquids found to have variable and inconsistent dosing directions and measuring devices

Top-selling pediatric OTC analgesic, cough and cold, allergy, and gastrointestinal liquid medications in the United States are plagued with highly variable and inconsistent dosing directions and measuring devices, according to a study published ahead-of-print on the Journal of the American Medical Association's website.

Etanercept use associated with significant increases in height, weight, BMI in children with arthritis

Researchers from the Cincinnati Children's Hospital Medical Center have demonstrated that the tumor necrosis factor-alpha inhibitor etanercept is associated with significant increases in height, weight, and body mass index in children with juvenile idiopathic arthritis, according to a study recently published in Arthritis & Rheumatism.

Oncology benefit management undergoing an evolution

Oncology treatment and benefits are changing. Buy-and-bill, the traditional methodology that had physicians buy chemotherapeutic products, treat in the office, and bill the payer, is going the way of surgery by barbers. But no one is quite sure what will replace the one-time standard of payment.

Pfizer voluntarily withdraws sitaxsentan from the market worldwide and halts ongoing clinical trials

Based on "a review of emerging safety information from clinical trials and postmarketing reports," Pfizer announced it would be voluntarily withdrawing sitaxsentan (Thelin), the manufacturer's pulmonary artery hypertension (PAH) treatment from the market worldwide.

Congress, regulators face reform challenges, funding issues in the year ahead

The political tensions wrought by last November's mid-term elections will play out in a number of situations affecting health plans and pharmaceutical companies this year.

Switching statins leads to lower therapy persistence

Patients who switch statins have lower persistence to therapy compared to those who don't switch, found Gary J. Tereso, PharmD, director of pharmacy services at Health New England, Springfield, Mass.

Denosumab superior to zoledronic acid in delaying skeletal-related side effects in breast cancer patients

A newly approved drug, denosumab (Xgeva, Amgen), delays skeletal-related side effects for 5 months longer compared to zoledronic acid (Zometa and Reclast, Novartis) in patients with breast cancer and bone metastases, according to phase 3 trial results presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas.

Formulary Digital Edition January 2011

Plaque psoriasis: A review of recent guidelines and pharmacologic therapies; Technosphere insulin: An inhaled mealtime insulin for the treatment of type 1 and type 2 diabetes mellitus; Agents in late-stage development for the treatment of osteoporosis and related bone disease

No safety issues observed with combination treatment for recurrent herpes simplex labialis

Treatment of recurrent herpes simplex labialis with combination 5% acyclovir and 1% hydrocortisone cream is safe in adolescents. In a study of a 5-day treatment course, no safety concerns were identified, said Anders Strand, MD, PhD, at the 45th midyear meeting of the American Society of Health Systems Pharmacists, in Anaheim, Calif.

Patients rarely remain on varenicline in effort to quit smoking

Few patients who are prescribed varenicline to assist in smoking cessation remain on the therapy, according to retrospective data presented during the 45th midyear meeting of the American Society of Health Systems Pharmacists, in Anaheim, Calif.