Drug Formulary Review articles from February 2005

Drug Formulary Review archives from February 2005

VHA consultants strive to improve pharmacy position in member hospitals: managing high-cost, high-risk drugs always will be a challenge.
February 1, 2005... A national health cooperative is using a team of in-house consultants to help increase the efficiency of pharmacy departments in member hospitals. The program has resulted in a typical 10-to-1 return on investment (3-to-1 guaranteed) for...

Pharmacists urged to ask patients about CAM use: more turning to alternative therapies due to cost.
February 1, 2005... Health trend researchers are urging pharmacists more than ever to ask patients about possible use of complementary and alternative medicine (CAM). Not only are cost concerns driving more lower-income, uninsured patients to try alternative...

Aromatase inhibitor shows promise in reducing breast cancer recurrence: physicians are divided on its use.
February 1, 2005... New research shows that aromatase inhibitor anastrozole (Arimidex) may be more effective than tamoxifen in preventing recurrence of breast cancer. These results from the breast cancer trial "Arimidex, Tamoxifen, Alone, or in Combination...

FDA recommends limiting COX-2 inhibitors use: an advisory committee should meet this month.
February 1, 2005... The questions continue about the safety of COX-2 selective nonsteroidal anti-inflammatory drugs (NSAIDs). First Merck withdrew rofecoxib (Vioxx) from the market in late September 2004 because of increased risk of heart attack and stroke....

FDA: gefitinib (Iressa) does not prolong survival.(Brief Article)
February 1, 2005... The FDA issued a statement last December urging patients who take gefitinib (Iressa) to consult their physicians, since gefitinib failed to show in a clinical trial an overall survival advantage in treating patients with lung cancer. The...

The FDA adds warnings to bevacizumab (Avastin) label.(Brief Article)
February 1, 2005... The FDA and Genentech have notified health care professionals about revisions to the label of bevacizumab (Avastin). Bevacizumab, used in combination with intravenous 5-fluorouracil-based chemotherapy, is indicated for first-line treatment of...

Computer entry cases medication errors.
February 1, 2005... The United States Pharmacopeia (USP) in Rockville, MD, has reported that nearly 20% of hospital and health system medication errors reported to USP's MEDMARX[SM] program in 2003 involved computerization or automation. However, facilities that...

Americans still confident about prescription drugs.(Brief Article)
February 1, 2005... Most Americans say they're confident about the safety of prescription drugs sold in the United States, according to an Associated Press (AP) poll. The poll was taken after questions were raised about celecoxib (Celebrex) and more than two...

Pegaptanib sodium injection (Macugen) by Eyetech Pharmaceuticals and Pfizer.(New FDA Approvals)(Brief Article)
February 1, 2005... The FDA has approved pegaptanib sodium injection (Macugen), a new therapy to slow vision loss in people with neovascular (wet) age-related macular degeneration (AMD). Pegaptanib is a selective vascular endothelial growth factor antagonist....

Palifermin (Kepivance) by Amgen.(New FDA Approvals)(Brief Article)
February 1, 2005... The FDA has approved palifermin (Kepivance), a new intravenous biologic product, to help reduce the chance that certain cancer patients (those with blood cancers undergoing chemotherapy and radiation in preparation for bone marrow transplants)...

Pregabalin capsules (Lyrica) by Pfizer.(New FDA Approvals)(Brief Article)
February 1, 2005... The FDA has approved pregabalin capsules (Lyrica) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN). Pregabalin is the first FDA-approved treatment for both of these...

Clofarabine (Clolar) by Genzyme Corp.(New FDA Approvals)
February 1, 2005... The FDA has approved clofarabine (Clolar) for the treatment of children with refractory or relapsed acute lymphoblastic leukemia (ALL). Clofarabine is the first new leukemia treatment approved specifically for children in more than a decade....

Duloxetine (Cymbalta) formulary evaluation: Part 2: clinical trial summary, treatment of peripheral neuropathy, conclusion/recommendation.
February 1, 2005... Clinical trial summary Duloxetine has been studied in several randomized, placebo-controlled clinical trials. The following three trials determine duloxetine to be efficacious in the treatment of major depressive disorder (MDD) in adults....

Multiple myeloma.(In The Pipeline)(Brief Article)
February 1, 2005... Kosan Biosciences has announced that the FDA has granted the company's anticancer compound 17-allylamino-17-demethoxy-geldanamycin (17-AAG), an analog of the polyketide geldanamycin, orphan drug status for the treatment of multiple myeloma.

Hepatitis C virus genotype 1.(In The Pipeline)(Brief Article)
February 1, 2005... Schering-Plough is initiating two large international clinical trials to evaluate the use of peginterferon alfa-2b (PegIntron) and ribavirin (Rebetol) combination therapy in patients chronically infected with hepatitis C virus genotype 1 who...

Acute myelogenous leukemia.(In The Pipeline)(Brief Article)
February 1, 2005... Vion Pharmaceuticals has been granted orphan drug designation from the FDA for VNP40101M (Cloretazine) for the treatment of acute myelogenous leukemia.

Chronic myelogenous leukemia.(In The Pipeline)(Brief Article)
February 1, 2005... Kosan Biosciences has announced that the FDA has granted its anticancer compound 17-allylamino-17-demethoxy-geldanamycin, or 17-AAG, orphan drug status for the treatment of chronic myelogenous leukemia.

Renal cell carcinoma.(In The Pipeline)(Brief Article)
February 1, 2005... Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals have announced that sorafenib (BAY 43-9006) has been granted orphan drug status by the FDA for the treatment of renal cell carcinoma.

Nosomial pneumonia.(In The Pipeline)(Brief Article)
February 1, 2005... Peninsula Pharmaceuticals has announced that the FDA has granted fast-track designation for doripenem (S-4661) for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia.

Mild-to-moderate congestive heart failure.(In The Pipeline)(Brief Article)
February 1, 2005... Neurocrine Biosciences has initiated a Phase I clinical trial with its proprietary compound, urocortin 2, to evaluate the safety, pharmacokinetics, and pharmacodynamics of urocortin 2 in healthy volunteers and also expects to initiate a Phase...

Hybridon has begun patient enrollment of a Phase II trial of HYB2055.(In The Pipeline)(Brief Article)
February 1, 2005... Hybridon has begun patient enrollment of a Phase II trial of HYB2055 (IMOxine) in renal cell carcinoma.

Paroxysmal nocturnal hemoglobinuria.(In The Pipeline)(Brief Article)
February 1, 2005... Alexion Pharmaceuticals has initiated the treatment phase in the Phase III TRIUMPH trial, evaluating the investigational drug eculizu-mab in patients with paroxysmal nocturnal hemoglobinuria.

Hepatitis C virus infection.(In The Pipeline)(Brief Article)
February 1, 2005... Vertex Pharmaceuticals has initiated a Phase Ib clinical trial for VX-950, an investigational oral protease inhibitor for the treatment of hepatitis C virus infection.

HIV-infected individuals.(In The Pipeline)(Brief Article)
February 1, 2005... Pharmasset has initiated a Phase II clinical study to assess the safety, tolerability, and antiviral effect of substituting Racivir (RCV) for lamivudine, 3TC (Epivir) in treatment-experienced HIV-infected individuals.

IgA nephropathy and delayed kidney failure.(In The Pipeline)(Brief Article)
February 1, 2005... CuraGen Corp. has announced that the FDA has granted orphan drug designation to CR002, a fully human monoclonal antibody, as a potential treatment to slow the progression of IgA nephropathy and delayed kidney failure in patients affected by the...

Peripheral arterial disease.(In The Pipeline)(Brief Article)
February 1, 2005... Vasogen has reached full enrollment in its 500-patient Phase III SIMPADICO trial of immune modulation therapy (Celacade) for the treatment of peripheral arterial disease.

Hormone refractory prostate cancer.(In The Pipeline)(Brief Article)
February 1, 2005... Lorus Therapeutics has initiated a clinical trial of its antisense drug, GTI-2040, in combination with docetaxel and prednisone in hormone refractory prostate cancer.

Treatment of glioma.(In The Pipeline)(Brief Article)
February 1, 2005... YM BioSciences and its majority-owned subsidiary CIMYM have announced that the Office of Orphan Products Development of the FDA has granted orphan drug designation to their EGF receptor monoclonal antibody, TheraCIM hR3, for the treatment of...

Chronic hepatitis C.(In The Pipeline)
February 1, 2005... Human Genome Sciences has begun dosing patients in a Phase II clinical trial of albumin-interferon alpha (Albuferon) in combination with ribavirin to evaluate the safety, tolerability, and efficacy of albumin-interferon alpha in patients with...

Phenylketonuria.(In The Pipeline)(Brief Article)
February 1, 2005... BioMarin Pharmaceutical expects to initiate a six-week, multicenter, international, double-blind, placebo-controlled Phase III clinical trial of sapropterin hydrochloride (Phenoptin) in phenylketonuria in the first quarter of 2005.

CE questions.
February 1, 2005... Pharmacists participate in this continuing education program by reading the article, using the provided references for further research, and studying the CE questions. Participants should select what they believe to be the correct answers. ...

News Briefs.
February 1, 2005... FDA: Gefitinib (Iressa) does not prolong survival The FDA issued a statement last December urging patients who take gefitinib (Iressa) to consult their physicians, since gefitinib failed to show in a clinical trial an overall survival...

In the Pipleline.
February 1, 2005... * Kosan Biosciences has announced that the FDA has granted the company's anticancer compound 17-allylamino-17-demethoxy-geldanamycin (17-AAG), an analog of the polyketide geldanamycin, orphan drug status for the treatment of multiple myeloma....