Formulary Watch |

Drug products recalled for possible penicillin cross-contamination

Aidapak Services has issued a voluntary recall of a large number of repackaged drug products after learning of the potential cross contamination of non-penicillin with penicillin drug products repackaged in the same facility.

FDA reviews safety of drospirenone for increased DVT, PE risk

FDA is assessing new information indicating an association between birth control pills containing the progestin hormone drospirenone and an increased risk of deep vein thrombosis and pulmonary embolus.

For severe gouty arthritis, ACZ885 provides better pain relief and reduces risk of new attacks

An investigational, fully human monoclonal antibody called ACZ885 (canakinumab) provided better pain relief in treating severe gouty arthritis, and it reduced the risk of new attacks by up to 68% compared with an injectable steroid (triamcinolone acetonide), according to results of 2 phase 3 trials announced by Novartis, the drug?s manufacturer.

Lomitapide still looks promising at 56 weeks

A 56-week phase 3 data for orphan drug lomitapide are consistent with 26-week data, showing that the drug significantly reduced low density lipoprotein cholesterol levels in patients with homozygous familial hypercholesterolemia, according to the drug?s manufacturer Aegerion Pharmaceuticals.

Lacosamide demonstrates potential cost savings as add-on seizure therapy

Lacosamide (Vimpat, UCB) appears both cost- and utility-effective as an add-on therapy for adults with uncontrolled partial-onset seizure, according to a pharmacoeconomics analysis that was recently presented at the International Society for Pharmacoeconomics Research.

Higher calcium intake may not lower risk of fracture or osteoporosis

Dietary calcium intake above 750 mg does not provide added benefit against risk of fractures or osteoporosis, according to the results of a large prospective longitudinal cohort study reported in the May 24 issue of the British Medical Journal.

IACs linked to increased risk of acute urinary retention in men with COPD

Use of short- and long-acting inhaled anticholinergic medications in men with chronic obstructive pulmonary disease is associated with an increased risk of acute urinary retention, according to the results of a study published in the May 23 issue of Archives of Internal Medicine.

REMS now available for Avandia; access to drug restricted

FDA announced May 18 to the public new restrictions to the prescribing, dispensing, and use of rosiglitazone-containing medications (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline [GSK]) as part of a Risk Evaluation and Mitigation Strategy.

Trilipix to stay on market, but FDA panel recommends new study

An FDA advisory panel recommended fenofibric acid (Trilipix, Abbott) still be marketed for use but voted unanimously that Abbott be required to conduct a new study to determine whether a Trilipix-statin combination reduces heart attacks.

Study finds unexpectedly high risk of hypertension for young adults

Nearly 20% of young adults in the United States may have high blood pressure, according to an analysis of the NIH-funded National Longitudinal Study of Adolescent Health (Add Health) published online May 23 in Epidemiology.

FDA approves Solesta for fecal incontinence in adult patients

FDA has approved a sterile, injectable gel (Solesta, Oceana Therapetucis) as a treatment for fecal (bowel) incontinence in adult patients who have not responded to conservative therapy such as dietary control.

Fixed-dose combination ARB plus CLD significantly lowers blood pressure

An investigational fixed-dose therapy showed promising results in lowering blood pressure compared with study comparators, according to the results of three phase 3 studies presented at the 26th annual American Society of Hypertension (ASH) Scientific Meeting and Exposition in New York.

Abiraterone acetate may improve survival for patients with metastatic advanced prostate cancer

Patients with metastatic castration-resistant prostate cancer treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo, according to a phase 3 study published in the May 26 issue of the New England Journal of Medicine.

FDA approves Dificid for treatment of Clostridium difficile-associated diarrhea

FDA approved fidaxomicin (Dificid, Optimer Pharmaceuticals) tablets for the treatment of Clostridium difficile-associated diarrhea.

Antihyperglycemic agents useful as third agent, but class preference unclear

There is no clear difference in benefit between drug classes when adding an antihyperglycemic as a third agent to the treatment of patients with type 2 diabetes who are already receiving metformin and a sulfonylurea, according to a meta-analysis published in the May 17 issue of Annals of Internal Medicine.

Formulary Digital Edition June 2011

Multiple sclerosis: A paradigm change with oral agents?; Focus On Telaprevir: A novel, protease inhibitor for the treatment of hepatitis C virus

Expect comparative effectiveness research to play a more notable role in payer policies, programs

Comparative effectiveness research will take a more prominent role in payer policies and programs, as the Patient-Centered Outcomes Research Institute will increase CER and CER will be used by Medicare and managed care organizations in development of clinical policies and programs, according to a recent audio conference.

Policy-makers move to curb drug abuse, diversion and disruptions to ensure quality supply

The proper use of prescription drugs is central to a number of important regulatory and public policies issues now in the spotlight.

Ranibizumab and bevacizumab show equivalent effects on visual acuity in patients with neovascular AMD

Two of the most commonly used treatments for neovascular age-related macular degeneration, ranibizumab, approved by FDA in 2006, and the other commonly used 'off-label', bevacizumab, resulted in similar improvements in visual acuity, according to results of a new trial.

Topiramate reclassified as Category D due to potential link to oral clefts in newborns

FDA announced that it was reclassifying topiramate from a Pregnancy Category C to a Pregnancy Category D drug.

Academy of Managed Care Pharmacy: Cancer, diabetes, cardiovascular agents fill pipeline

The pipeline continues to decline from 4 to 5 years ago where smaller molecules led the way, according to a current state of the pharmaceutical pipeline presentation at the Academy of Managed Care Pharmacy's 23rd Annual Meeting and Showcase in Minneapolis.

Telaprevir: A novel, protease inhibitor for the treatment of hepatitis C virus

Chronic hepatitis C virus affects more than 170 million people worldwide and is the most common chronic blood-borne infection in the United States. Telaprevir is a member of a new class of specifically targeted antiviral therapies for HCV.

Gabapentin enacarbil extended-release tablets (Horizant): Treatment for moderate-to-severe restless legs syndrome

New molecular entity: Gabapentin enacarbil extended-release tablets was approved by FDA as treatment for moderate-to-severe restless legs syndrome in adults.

Multiple sclerosis: A paradigm change with oral agents?

Multiple sclerosis is the most common disabling neurologic disease afflicting young adults in the United States. Since the majority of MS patients have normal or near-normal life expectancy, the clinical and economic burden is substantial, with disability typically worsening over time. Disease-modifying therapies have been shown to decrease and postpone long-term disability by lowering the relapse rate, extending the remission phase, and reducing the accumulation of new magnetic resonance imaging lesions and related neurologic deficits.

Academy of Managed Care Pharmacy: Specialty drug approvals trend upward; biobetters gain momentum

Within the next 5 years, approximately $100 billion will be lost on previous blockbuster brands that will lose patent protection.

FDA Pipeline Preview, June 2011 (BioMimetic Therapeutics, Pfizer, D-Pharm, Bayer HealthCare Pharmaceuticals, Mithridion, Cytonet)

Recent FDA action (through May 2011) related to Augment Bone Graft, crizotinib, DP-b99 development program, regorafenib, MCD-386CR, liver cell infusion of donated human liver cells

Belimumab intravenous injection (Benlysta): IV injection for the treatment of adult patients with active autoantibody-positive systemic lupus erythematosus already receiving standard therapy

New biologic: Belimumab intravenous injection is a B-lymphocyte stimulator-specific inhibitor approved by FDA to treat systemic lupus erythematosus.

First-time generic approval June 2011

Generic drugs approved by FDA (through May 2011): bromfenac ophthalmic solution 0.09%, sodium ferric gluconate complex in sucrose injection, nitrofurantoin oral suspension

FDA Actions in Brief June 2011 (Incivek, Victrelis, Edurant, Sutent, Argatroban injection, Afinitor, Tradjenta, Fusilev)

Recent FDA Approvals (through May 2011) related to Incivek, Victrelis, Edurant, Sutent, Argatroban injection, Afinitor, Tradjenta, Fusilev

Specialty drug approvals trend upward; biobetters gain momentum

Within the next 5 years approximately $100 billion will be lost on previous blockbuster brands that will lose (or lost) patent protection. For manufacturers to enhance their return on investment, they are refocusing on researching and marketing specialty drugs, according to a specialty pharmaceuticals pipeline update at the Academy of Managed Care Pharmacy?s 23rd Annual Meeting and Showcase, Minneapolis.