Formulary Watch |

Calcitriol (Vectical): Vitamin D analogue approved for the treatment of mild-to-moderate plaque psoriasis

New formulation: Calcitriol (Vectical), a Vitamin D analogue, was approved on January 23, 2009, for the treatment of mild-to-moderate plaque psoriasis

Antithrombin (recombinant) (ATryn): Recombinant human antithrombin approved for the prevention of perioperative and peripartum thromboembolic events in hereditary antithrombin-deficient patients

New biologic: Antithrombin (recombinant) (ATryn), a recombinant human antithrombin, was approved on February 6, 2009, for the prevention of perioperative and peripartum thromboembolic events in hereditary antithrombin-deficient patients

Febuxostat (Uloric): Xanthine oxidase inhibitor approved for chronic management of hyperuricemia in patients with gout

Febuxostat (Uloric): Xanthine oxidase inhibitor approved for chronic management of hyperuricemia in patients with gout

Drug Watch: Agents in late-stage development for the treatment of pulmonary diseases (March 2009) (PDF)

Agents in late-stage development for the treatment of asthma, COPD, and PAH

FDA advisory committees recommend ban on Darvon, Darvocet

At a joint meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees on January 30, 2009, advisors voted 14 to 12 that propoxyphene and propoxyphene-containing products should be removed from the market. Propoxyphene (Darvon, Xanodyne; generic propoxyphene) and propoxyphene combinations, including Darvocet (Xanodyne), are used for the treatment of mild-to-moderate acute pain.

Loop diuretics have mixed effects on fracture risk

In an analysis of fracture risk associated with loop diuretic use among postmenopausal women in the Women's Health Initiative (WHI) study, investigators demonstrated no significant association between loop diuretic use and fractures or changes in bone mineral density (BMD). With prolonged use of loop diuretics, however, the risk of fracture was modestly increased.

Breast cancer incidence reduced after discontinuation of estrogen plus progestin

Initial results of the Women's Health Initiative (WHI) study demonstrated an increased risk of breast cancer among postmenopausal women treated with estrogen plus progestin. A new long-term analysis of this study published in the New England Journal of Medicine demonstrated that breast cancer incidence decreased markedly after WHI study participants discontinued hormone therapy.

Daschle's withdrawal raises doubts about healthcare reform

Development of axitinib for pancreatic cancer discontinued

Pfizer is discontinuing a phase 3 study of axitinib for the treatment of advanced pancreatic cancer. An analysis by an independent data safety monitoring board demonstrated that there was no improvement in survival among patients treated with axitininb plus gemcitabine versus those treated with gemcitabine alone.

Prasugrel unanimously recommended for approval

On February 3, the FDA Cardiovascular and Renal Drugs Advisory Committee unanimously recommended that prasugrel (Daiichi Sankyo/Lilly) should be approved for the treatment of patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI).

Formulary Digital Edition February 2009

Review of ARV agents for the treatment of HIV infection; Focus on dronedarone; Drug Watch: Agents in late-stage development for the treatment of HIV and AIDS

Drug Watch: Agents in late-stage development for the treatment of HIV and AIDS (February 2009) (PDF)

Agents in late-stage development for the treatment of HIV and AIDS

FDA Pipeline preview, February 2009 (asenapine, certolizumab, olanzapine long-acting injection, ustekinumab, oritavancin, rotigotine, vigabatrin)

Recent FDA action (through February 2009) related to asenapine, certolizumab, olanzapine long-acting injection, ustekinumab, oritavancin, rotigotine, and vigabatrin

Preventable medication errors: Look-alike/sound-alike mix-ups

Confusing drug names, or "look-alike/sound-alike names" (LASAs), are among the most common reasons for medication errors worldwide; these errors can lead to both morbidity and mortality. Both technological innovations and better communication can help healthcare professionals track and prevent these medication mix-ups.

Healthcare reform requires a hard look at drug costs and savings

Dronedarone: An antiarrhythmic agent for the management of atrial fibrillation and atrial flutter

Dronedarone, an investigational antiarrhythmic agent being studied for the management of AF and atrial flutter, has a pharmacologic mechanism of action that is similar to that of amiodarone, but dronedarone lacks an iodine moiety, which may result in less thyroid and pulmonary toxicity. Dronedarone is currently pending FDA approval; the agent was granted priority review in August 2008.

Review of antiretroviral agents for the treatment of HIV infection

The challenge of controlling HIV in patients with resistance to antiretrovirals has contributed to accelerated research into treatments with novel antiretroviral activity.

FDA actions in brief, February 2009 (Vasovist, Lusedra, Zingo, Latisse, Gleevec, Nexterone, Zolpimist, Trilipix, Ryzolt, Epiduo, AllerNaze)

Recent FDA approvals (through Feburary 2009) related to Vasovist, Lusedra, Zingo, Latisse, Gleevec, Nexterone, Zolpimist, Trilipix, Ryzolt, Epiduo, and AllerNaze

Plerixafor (Mozobil): Hematopoietic stem cell mobilizer approved for mobilization of hematopoietic stem cells for autologous transplantation in patients with NHL and MM

New molecular entity: Plerixafor (Mozobil), a hematopoietic stem cell mobilizer, was approved on December 15, 2008, for mobilization of hematopoietic stem cells for autologous transplantation in patients with NHL and MM

Degarelix: GnRH receptor antagonist approved for the treatment of advanced prostate cancer

New molecular entity: Degarelix, a GnRH receptor antagonist, was approved on December 24, 2008, for the treatment of advanced prostate cancer

Milnacipran (Savella): Selective norepinephrine and serotonin reuptake inhibitor approved for the management of fibromyalgia

New molecular entity: Milnacipran (Savella), a selective norepinephrine and serotonin reuptake inhibitor, was approved on January 14, 2009, for the management of fibromyalgia

FDA seeks more resources and new leadership

For the last few years, FDA has struggled with a depleted workforce, obsolete information technology (IT), and, according to its advisory Science Board, a weak science base. A new administration and new FDA leadership may provide an opportunity for change.

FDA guidance on reprint practices: Dissemination of off-label information OK

In newly released guidance for industry regarding good reprint practices for the distribution of journal articles and reference publications on off-label uses of approved drugs, FDA states that distribution of such materials is acceptable if the publications meet certain criteria for objectivity.

FDA: Ezetimibe/simvastatin (Vytorin) effective in lowering LDL

After completing a review of the final clinical study report from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial, FDA stated that treatment with ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough) did not result in significant changes in carotid artery thickness compared with simvastatin (Zocor, Merck), but the combination of ezetimibe and simvastatin did lead to significantly greater decreases in low-density lipoprotein (LDL) cholesterol compared with simvastatin alone.

Antidepressants associated with improvements in fibromyalgia symptoms

A meta-analysis published in the Journal of the American Medical Association demonstrated an association between antidepressants and improvements in pain, depression, fatigue, sleep, and health-related quality of life (HRQOL) in patients with fibromyalgia syndrome (FMS).

Telepharmacy reaches out to the underserved

Not so long ago, medically underserved rural communities had only limited options, if any, when need arose for healthcare services and pharmaceutical support. That situation is finally changing, as necessity and technology converge in emerging applications of telepharmacy, the delivery of pharmaceutical care by means of telecommunications and information technologies to patients at a distance from large, usually urban tertiary healthcare centers.

In the pipeline: Drugs to watch in 2009

Several blockbuster drugs will fight to hold onto their top spots in 2009 as new products come before FDA for marketing approval, reported Brian W. Kolling, PharmD, at a recent meeting of the Academy of Managed Care Pharmacy (AMCP) in Kansas City, Mo. Key therapies to watch as they move through the pipeline include medications for cardiovascular (CV) disorders, central nervous system (CNS) disorders, respiratory disease, and diabetes.

Formulary Digital Edition January 2009

Outpatient pharmacologic management of ACS using antiplatelet therapy; Focus on sugammadex; Drug Watch: Agents in late-stage development for the treatment of depression and generalized anxiety disorder

Eltrombopag (Promacta): Thrombopoietin (TPO) receptor agonist approved for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP)

New molecular entity: Eltrombopag (Promacta), a TPO receptor agonist, was approved on November 20, 2008, for the treatment of thrombocytopenia in patients with chronic ITP.

FDA Pipeline preview, January 2009 (ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, ecallantide)

Recent FDA action (through January 2009) related to ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, and ecallantide