Formulary Watch |

Rosuvastatin associated with significant stroke risk reduction in patients with high hsCRP

Apparently healthy people with normal cholesterol levels but elevated levels of high-sensitivity C-reactive protein (hsCRP) demonstrated a significant relative reduction in stroke risk if treated with rosuvastatin rather than placebo in the Justification for Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, according to data presented at the International Stroke Conference 2009.

Few hospitals give t-PA to patients with ischemic stroke who are covered by Medicare

Two-thirds of US hospitals do not administer tissue plasminogen activator (t-PA) to patients who have a stroke and are covered by Medicare, according to the results of a national study conducted between 2005 and 2007, which were presented at the International Stroke Conference 2009.

Transdermal medication patches may lead to burns during MRI scans

FDA has issued a public health advisory regarding a risk of burns during magnetic resonance imaging (MRI) scans in patients wearing transdermal medication patches that contain aluminum or other metals in the backing of the patches. The patches can overheat during the scan, leading to skin burns in the area of the patch.

Boxed warning about tardive dyskinesia added to metoclopramide label

FDA has stated that manufacturers of metoclopramide must add a boxed warning to their drug labels regarding the risk of tardive dyskinesia with long-term or high-dose use of this agent.

Elesclomol trials suspended because of safety concerns

Synta Pharmaceuticals and GlaxoSmithKline have announced that they are suspending a phase 3 trial of elesclomol in chemotherapy-naïve patients with stage IV metastatic melanoma because of safety concerns.

Debate over follow-on biologic legislation continues

At the 2009 annual meeting of the Generic Pharmaceutical Association (GPhA) in February, House Energy and Commerce Committee Chairman Henry Waxman told attendees that a workable scientific, regulatory, and legal pathway for follow-on biologics (also referred to as biogenerics or biosimilar pharmaceuticals) would lead to more affordable medications for Americans.

Intraventricular delivery of t-PA improves outcomes in intraventricular hemorrhage

Catheter delivery of tissue plasminogen activator (t-PA) improves survival and functional outcomes at 6 months in patients with intraventricular hemorrhage (IVH), according to the final results from a phase 2b study known as Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR IVH).

Bevasiranib trial for wet-AMD discontinued

OPKO Health announced that it is terminating a phase 3 trial of bevasiranib for the treatment of wet age-related macular degeneration (wet-AMD).

Maribavir trial for CMV prophylaxis discontinued

ViroPharma has announced that it is discontinuing a phase 3 trial of maribavir for prophylaxis against cytomegalovirus (CMV) disease in patients undergoing a liver transplant.

Supreme Court rules against Wyeth in Wyeth v Levine

In a decision handed down March 4, 2009, the U.S. Supreme Court ruled in favor of Levine in the court case Wyeth v Levine, upholding the ruling of the Vermont Supreme Court. This decision may set a precedent for rejecting the argument of pre-emption, a tenet holding that FDA regulations connected with drug approvals and medication safety supersede state laws.

Sebelius nominated for secretary of HHS

In a news conference on March 2, President Obama nominated Kansas Governor Kathleen Sebelius to the post of secretary of Health and Human Services (HHS). He also nominated Nancy Ann DeParle to the post of director of the White House Office for Health Reform.

Formulary Digital Edition March 2009

Review of common sexually transmitted diseases; Focus on ustekinumab; Drug Watch: Agents in late-stage development for the treatment of pulmonary diseases

Labeling updates and warnings through March 2009 for zonisamide and efalizumab

Labeling updates and warnings through March 2009 for zonisamide and efalizumab

Anti-TNF-alpha monoclonal antibodies associated with increased risk of herpes zoster

In a study published in the Journal of the American Medical Association, investigators demonstrated an association between treatment with the anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies (mAbs) adalimumab and infliximab and risk of herpes zoster events in patients with rheumatoid arthritis (RA).

Higher continuity of statin use associated with decreased all-cause mortality

In a retrospective cohort study published in the Archives of Internal Medicine, higher continuity of statin treatment was associated with a lower risk of all-cause mortality among patients with or without coronary heart disease (CHD).

Healthcare reformers seek greater transparency in drug prices, marketing, and research

A prominent theme in health-reform efforts is the need for more transparent information about healthcare cost and quality upon which providers and patients can base their treatment decisions. Many federal agencies and state governments are expanding their requirements for pharmaceutical companies to report payments made to researchers and physicians, and for health plans to give beneficiaries more information on drug costs and coverage.

A review of common sexually transmitted diseases

Although there have been significant advances in prevention, diagnosis, treatment, and education, the occurrence of sexually transmitted diseases (STDs) continues to increase. This article focuses on the diagnosis and treatment of the most common STDs.

First-time generic drug approvals, March 2009

Generic drugs approved by FDA (through March 2009) including sumatriptan tablets, divalproex extended-release tablets, and risperidone oral solution

FDA actions in brief, March 2009 (Gelnique, RiaSTAP, Kapidex)

Recent FDA approvals (through March 2009) related to Gelnique, RiaSTAP, and Kapidex

FDA Pipeline preview, March 2009 (cetuximab, prasugrel, risperidone, iclaprim, lasofoxifene, ecallantide, laquinimod, C1 inhibitor, SGN-35, omacetaxine)

Recent FDA action (through March 2009) related to cetuximab, prasugrel, risperidone, iclaprim, lasofoxifene, ecallantide, laquinimod, C1 inhibitor, SGN-35, and omacetaxine

Ustekinumab: A human monoclonal antibody for the treatment of plaque psoriasis

Ustekinumab is a novel investigational human monoclonal antibody (mAb) that is pending approval for the treatment of plaque psoriasis. Subcutaneous administration of ustekinumab has demonstrated efficacy in both phase 2 and 3 trials.

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.