Formulary Watch |

FDA issues early communication about ongoing safety review of orlistat

FDA is reviewing reports of liver injury in patients treated with orlistat (prescription drug, Xenical; OTC drug, Alli) for obesity management or weight loss.

Etravirine associated with severe skin and hypersensitivity reactions

Tibotec has issued a Dear Healthcare Professionals letter regarding an increased risk of fatality caused by toxic epidermal necrolysis and hypersensitivity reactions, sometimes accompanied by hepatic failure, in patients treated with etravirine (Intelence).

Medication interventions get a boost from a powerful tool

Pharmacists can improve patient outcomes by following 3 major functions: identification of potential and actual medication-related problems (MRPs), resolution of actual MRPs, and prevention of potential MRPs. The best way to achieve these goals is through accurate documentation, and one of the chief obstacles to this is time?or rather the lack of it. Various software programs have been developed to help pharmacists reduce time spent identifying opportunities for interventions.

Perioperative fluvastatin treatment associated with improved CV outcome after noncardiac vascular surgery

In the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography III (DECREASE III) trial published in the New England Journal of Medicine, patients undergoing noncardiac vascular surgery who were treated with perioperative fluvastatin demonstrated a lower incidence of myocardial ischemia than patients treated with placebo.

Ticagrelor associated with lower rate of death from vascular causes, MI, and stroke

In the Study of Platelet Inhibition and Patient Outcomes (PLATO) published in the New England Journal of Medicine, patients with acute coronary syndrome (ACS) who were treated with ticagrelor had significant reductions in the rate of death from vascular causes, myocardial infarction (MI), or stroke and no significant increase in the rate of overall major bleeding versus patients treated with clopidogrel.

Formulary Digital Edition September 2009

P&T considerations in fashioning a knowledge base, action plan for cardiometabolic disorders and weight; Focus on golimumab; Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders

Global health concerns generate new therapies for home and abroad

Bevacizumab (Avastin): Monoclonal antibody approved for the treatment of metastatic renal cell carcinoma in combination with interferon alfa

New indication: Bevacizumab (Avastin), a monoclonal antibody, was approved on July 31, 2009, for the treatment of metastatic renal cell carcinoma in combination with interferon alfa

First-time generic drug approval, September 2009: Tacrolimus capsules

Generic drug approved by FDA (through September 2009): tacrolimus capsules

P&T considerations in fashioning a knowledge base, action plan for cardiometabolic disorders and weight

FDA actions in brief, September 2009 (Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, Kogenate FS)

Recent FDA approvals (through September 2009) related to Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, and Kogenate FS

Saxagliptin (Onglyza): DPP-4 inhibitor approved for the treatment of type 2 diabetes mellitus

New molecular entity: Saxagliptin (Onglyza), a DPP-4 inhibitor, was approved on July 31, 2009, for the treatment of type 2 diabetes mellitus

Sumatriptan (Sumavel DosePro): Needle-free injection of 5-HT1 receptor agonist approved for the acute treatment of migraine and cluster headaches

New formulation: Sumatriptan (Sumavel DosePro) formulated as a needle-free injection was approved on July 15, 2009, for the acute treatment of migraine and cluster headaches

FDA Pipeline preview, September 2009 (cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, beclomethasone 17,21-dipropionate)

Recent FDA action (through September 2009) related to cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, and beclomethasone 17,21-dipropionate

Golimumab: A human anti-TNF-alpha monoclonal antibody for the treatment of autoimmune joint diseases

Golimumab is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody that was recently approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders (September 2009) (PDF)

Agents in late-stage development for the treatment of Crohn's disease, ulcerative colitis, irritable bowel syndrome, and short bowel syndrome

Trial of sildenafil for PAH in patients with sickle cell disease terminated because of safety concerns

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has prematurely terminated a trial of sildenafil for the treatment of pulmonary arterial hypertension (PAH) in adult patients with sickle cell disease because of safety concerns.

New warnings about malignancies in pediatric patients added to labels of TNF-blockers

After completing an analysis of safety data for tumor necrosis factor (TNF)-blockers, FDA has stated that there is an increased risk of lymphoma and other cancers in pediatric patients who are treated with these agents.

Development of bifeprunox for maintenance treatment of schizophrenia discontinued

Lundbeck and Solvay have announced that they are discontinuing development of bifeprunox for the maintenance treatment of schizophrenia.

Dirucotide trials for secondary progressive MS discontinued for lack of efficacy

Lilly and BioMS Medical reported that their investigational agent dirucotide did not meet the primary end point of delaying disease progression in patients with secondary progressive multiple sclerosis (SPMS) in the phase 3 MAESTRO-01 trial.

Alpha-blocker use in men associated with decreased incidence of sexual dysfunction

A study published in Urology demonstrated that alpha-blocker use is associated with a lower risk of sexual dysfunction in men aged >40 years.

Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients

Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients

Healthcare reform to shape drug coverage, costs, and R&D

Formulary Digital Edition August 2009

Emerging risk factors and risk markers for CV disease; Focus on rivaroxaban; Drug Watch: Agents in late-stage development for the treatment of osteoarthritis and acute/chronic pain

IVIg treatment associated with a reduced risk of Alzheimer's disease

In a retrospective analysis published in the journal Neurology, investigators demonstrated that previous treatment with intravenous immunoglobulin (IVIg) was associated with a reduced risk of the development of Alzheimer's disease and related disorders (ADRD) in patients aged at least 65 years.

Emerging risk factors and risk markers for cardiovascular disease: Looking beyond NCEP ATP III

This review discusses emerging risk factors for CVD, including hs-CRP, lipoprotein(a), homocysteine, fibrinogen, homocysteine, and coronary artery calcification.

FDA actions in brief, August 2009 (Ozurdex, Cambia, Ilaris, Feraheme, Plan B One-Step, Alimta, Isentress)

Recent FDA approvals (through August 2009) related to Ozurdex, Cambia, Ilaris, Feraheme, Plan B One-Step, Alimta, and Isentress

Rivaroxaban: A direct factor Xa inhibitor for VTE prophylaxis in patients undergoing total knee or hip replacement surgery

Rivaroxaban is a highly potent direct factor Xa inhibitor that is pending FDA approval for the indication of venous thromboembolism (VTE) prophylaxis in patients undergoing total knee replacement or total hip replacement surgery.

FDA Pipeline preview, August 2009 (trazodone, casopitant, sertindole, alogliptin, bepotastine, trabectedin, velaglucerase alfa)

Recent FDA action (through August 2009) related to trazodone, casopitant, sertindole, alogliptin, bepotastine, trabectedin, and velaglucerase alfa

First-time generic drug approval, August 2009

Generic drug approved by FDA (through August 2009): ethinyl estradiol/norgestimate tablets