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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.

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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: 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 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.

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.

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.

Pemoline removed from US market

In late October, FDA announced that pemoline will no longer be available in the United States because the risks of liver toxicity associated with the drug's use outweigh the benefits of the therapy.

Excessive reliance on class effect could negatively impact geriatric care

Too much reliance on class effect could undermine the medical care of geriatric patients, according to an article published in the Journal of the American Geriatric Society. In turn, the clinical community should work to ensure that sufficient choices remain to prescribe wisely for elderly patients, authors Mark H. Beers, MD, and Richard G. Stefanacci, DO, stated.

Acetaminophen, NSAIDs elevate hypertension risk in women

Acetaminophen at doses of more than 500 mg/d and nonsteroidal anti-inflammatory drugs (NSAIDs) at doses of more than 400 mg/d increase the risk of incident hypertension in younger and older women, according to cohort studies published in Hypertension.

FDA actions in brief

FDA extended the Prescription Drug User Fee Act action date to January 7, 2006, for lenalidomide (Revlimid, Celgene). The drug is intended to treat patients with transfusion-dependent anemia resulting from low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality.

Pipeline Preview

Muraglitazar (Pargluva, Bristol-Myers Squibb, Merck) for the treatment of type 2 diabetes.

Kaletra

This tablet formulation of lopinavir and ritonavir provides several advantages over the capsule formulation.

Humira

This recombinant IgG1 monoclonal antibody exerts its therapeutic effect through inhibition of human tumor necrosis factor (TNF).