Formulary Watch |

Focus On: Exubera An Orally inhaled insulin

Safety Labeling updates and new warnings

The labeling for darbepoetin alfa (Aranesp, Amgen) and epoetin alfa (Epogen, Amgen and Procrit, Ortho Biotech) was revised to include information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with the agents. This has been reported predominantly in patients with chronic renal failure receiving these products by subcutaneous administration.

Contraindicated metformin fares well in heart failure patients with diabetes

In an observational study of patients with type 2 diabetes being treated for heart failure, researchers found that metformin—whether used alone in vulnerable patients or in combination—is associated with lower mortality, less morbidity, and fewer hospitalizations compared with sulfonylurea monotherapy. The study, conducted in Canada, was published in Diabetes Care.

Effexor HR

This dual-acting antidepressant is believed to exert its effect through the inhibition of neuronal serotonin and norepinephrine reuptake. Venlafaxine was approved on November 18, 2005, for the treatment of panic disorder, with or without agoraphobia, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).

FDA actions in brief

The injectable antibiotic ertapenem (Invanz, Merck) was approved by FDA to treat moderate-to-severe complicated foot infections due to indicated pathogens in patients who have diabetes without osteomyelitis

Pipeline Preview

Thalidomide (Thalomid, Celgene) as a treatment for multiple myeloma

Tarceva

The epidermal growth factor receptor (EGFR) is expressed on the surface of normal cells and cancer cells, and erlotinib inhibits the intracellular phosphorylation of tyrosine kinase associated with EGFR.

Drug Watch: Agents in late-stage development for the treatment of asthma (November 2005) (PDF)

Review of agents in late-stage development for the treatment of asthma (November 2005).

Rapid Response Team to focus on countering potential threat of pandemic flu in the United States

In response to the emerging threat of pandemic (avian) influenza, FDA has announced the formation of a Rapid Response Team to ensure that antiviral drugs are available to citizens in the United States if they are needed. While avian flu has not emerged in this country, the team will help ensure an adequate supply of treatments, such as oseltamivir (Tamiflu, Roche) and other anti-influenza drugs, for stockpiling in the event there is an outbreak in the United States.

Prescription drug label information goes electronic

In an effort to meet the administration's goal of expanded electronic government, FDA is requiring drug manufacturers to submit prescription drug label information to the agency in a new electronic format. This electronic format will allow healthcare providers and consumers to more easily access the product information found in package inserts for all approved medications in the United States.

Uncertainty continues at FDA while the agency addresses drug safety; Medicare drug benefit rolls out

The future leadership of FDA remains highly uncertain following the unexpected resignation of commissioner Lester M. Crawford, DVM, PhD, in September. Andrew C. von Eschenbach, MD, director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), was named acting FDA commissioner, but conflict arose initially because Dr von Eschenbach wanted to retain a leadership role at NCI while also taking the helm of FDA. Although he handed over day-to-day leadership of NCI to a deputy, that move failed to fully appease critics concerned about conflicts of interest in advocating for speedy access to new cancer treatments while overseeing the safety and effectiveness of those therapies. Department of Health & Human Services (HHS) secretary Michael Leavitt has indicated that Dr von Eschenbach is not likely to get the top job at FDA on a permanent basis.

Statins may reduce prostate cancer risk

Men who have used 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors to reduce their cholesterol levels may be at less risk of developing prostate cancer, according to a case-control study published in the American Journal of Epidemiology.

From the ANA Annual Meeting: Eszopiclone demonstrates long-term safety and efficacy in 6-month study

Results from a 6-month, phase 3b/4 study of eszopiclone (Lunesta, Sepracor) in adult patients with chronic insomnia demonstrated that nightly use of eszopiclone 3 mg resulted in statistically significant improvements (P<.0001) compared with placebo in patient-reported measures of sleep latency (onset of sleep), sleep maintenance, total sleep time, and sleep quality. These results were announced in late September at the American Neurological Association (ANA) Annual Meeting in San Diego, Calif.

From the NAMS Annual Meeting: Eszopiclone offers multiple benefits in menopausal-associated insomnia

Eszopiclone (Lunesta, Sepracor), a novel, non-benzodiazepine sleep aid, shows significant value in the treatment of insomnia associated with menopause, said Claudio N. Soares, MD, PhD, at the North American Menopause Society's 16th annual meeting in San Diego, Calif.

From the NAMS Annual Meeting: Transdermal estradiol gel significantly decreases postmenopausal hot flashes

Results from a phase 3 clinical study demonstrate that a novel transdermal estradiol gel (Bio-E-Gel, BioSante) represents a major improvement in low-dose estrogen therapy, significantly reducing the frequency and severity of hot flashes in menopausal women in a dose-dependent manner at all 3 doses studied, with the low dose being identified as the lowest effective approach, stated James A. Simon, MD, at the North American Menopause Society's 16th annual meeting in San Diego.

From the ECNP Congress: Head-to-head study confirms atypical antipsychotic efficacy equivalence

Quetiapine (Seroquel, AstraZeneca), olanzapine (Zyprexa, Lilly), and risperidone (Risperdal, Janssen) are equally effective in patients experiencing first episode psychosis, according to data presented in late October during the Breaking News session at the European College of Neuropsychopharmacology (ECNP) Congress.

From the ESC Congress 2005: Drug-eluting stent is cost-effective only in high-risk subsets

In a "real-world" setting, drug-eluting stents are clinically superior to bare metal stents, but their use is currently cost-effective only in high-risk subsets of patients, according to results from BASKET (Basel Stent Kosten Effektivit?ts Trial).

From the ESC Congress 2005: Enoxaparin causes less bleeding than unfractionated heparin in PCI

A single IV bolus of enoxaparin (Lovenox, Aventis) is just as effective as and associated with less bleeding than unfractionated heparin in patients undergoing elective PCI, said Gilles Montalescot, MD. Dr Montalescot was lead investigator of STEEPLE (Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients), the results of which were announced during the the ESC Congress 2005 in Stockholm, Sweden.

USP to revise Medicare Prescription Drug Benefit Model Guidelines

USP has been awarded a cooperative agreement with the Centers for Medicare and Medicaid Services (CMS) to revise the Part D Prescription Drug Benefit Model Guidelines.

Hurricane Katrina prompts development of national electronic health records system

While Hurricane Katrina has disrupted healthcare for millions of people, one beneficial outcome may be more public and private efforts to develop a national electronic health records (EHR) system.

Levalbuterol no more efficacious than racemic albuterol in treatment of pediatric asthma

Children suffering from acute exacerbation of asthma can expect levalbuterol (Xopenex, Sepracor) (LEV) to produce results that are no better-yet are more costly-than racemic albuterol (RAC), according to a study published in Pediatric Emergency Care.

ACEIs, ARBs decrease new-onset type 2 diabetes in patients with hypertension, CAD, and HF

ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) possess a similar and significant ability to reduce the development of new-onset type 2 diabetes among patients with hypertension, coronary artery disease, and heart failure, according to a meta-analysis study published in Diabetes Care.

FDA Names new director of the Office of Drug Safety

In other drug safety news, FDA has announced the selection of Gerald J. Dal Pan, MD, MHS, as director, Office of Drug Safety in the Center for Drug Evaluation and Research (CDER). Dr Dal Pan, selected from a strong field of candidates as part of a nationwide search, will lead the agency's post-marketing drug safety program.

Health plans help FDA monitor drug safety through national databasestudies

Program will allow rapid access to population-based data sources tohelp ensure public safety

AMCP Special Report: AMCP calls for changes that would strengthen FDA oversight of DTC advertising

Judith Cahill, executive director of the Academy of Managed Care Pharmacy (AMCP), gave testimony in early November during FDA's public hearing on direct-to-consumer advertising (DTC) of pharmaceutical products.

AMCP Special Report: Development of highly innovative drugs continues to decline

Evaluation of newly released medications for potential formulary inclusion should focus on clinical benefit over product price or rebate. Dossiers are invaluable to the evaluation process, but it's important to note that dossiers obtained from pharmaceutical manufacturers are often incomplete, according to presenters at AMCP's 2005 Educational Conference last month in Nashville, Tenn.

AMCP Special Report: Adopting technologies based on cost-effectiveness ratios requires value judgment

Incremental cost-effectiveness ratios produced by pharmacoeconomic modeling are the gold standard for evaluating drug alternatives, but the result of such an analysis often requires a value judgment on the part of the managed care organization (MCO), Daniel C. Malone, PhD, RPh, said at the Academy of Managed Care Pharmacy's (AMCP's) 2005 Educational Conference last month in Nashville, Tenn.

Atrasentan: A novel selective endothelin-A receptor antagonist

Accumulating data have demonstrated that the endothelin axis plays a role in the progression of many malignancies. Endothelin-1, which is produced by prostate cancer cells, can stimulate new bone formation. It can also act synergistically with a number of growth factors promoting cancer cells growth and proliferation. Over-expression of endothelin-1 and diminished capacity for its clearance have been seen in prostate cancer cell lines. The highest concentration of endothelin-1 is found in patients with hormone refractory metastatic disease. Atrasentan (Xinlay, Abbott) is a member of a new class of drugs called the selective endothelin-A receptor antagonists (SERAs). The safety and efficacy of atrasentan in hormone refractory prostate cancer (HRPC) have been evaluated in several clinical trials. Atrasentan demonstrated some efficacy in delaying the progression of disease and improving patients' quality of life while having an acceptable safety profile. An NDA for atrasentan was submitted in December 2004 for..

FDA Advisory Committee update

FDA's Psychopharmacologic Drugs Advisory Committee voted unanimously on October 25 that long-term efficacy studies for antidepressants should not be required prior to approval.

Safety Labeling updates and new warnings

The manufacturer of ato-moxetine (Strattera, Lilly) was directed by FDA to revise the prescribing information for the drug to include a black box warning and additional statements that alert healthcare providers of an increased risk of suicidal thinking in children and adolescents being treated with this medication.