Formulary Watch |

Safety labeling updates & new warnings

A discussion of FDA-requested boxed warnings and medication labeling changes

Rate of anticoagulant-associated intracerebral hemorrhage quintuples

The rate of anticoagulant-associated intracerebral hemorrhage has increased dramatically since 1988, according to an observational study published in the journal Neurology. Researchers identified all patients hospitalized with first-ever intracerebral hemorrhage (ICH) in the 5-county Greater Cincinnati, Ohio/Northern Kentucky area during 3 unique time periods.

FDA actions in brief

A discussion of new FDA-approved indications and formulations of drugs

First-time generic approvals

A discussion of generic drugs recently approved by FDA

Pipeline preview

A discussion of drugs under consideration/review for FDA approval

Adalimumab

Recombinant monoclonal antibody approved for reducing the signs and symptoms and inducing and maintaining clinical remission of moderately-to-severely active Crohn's disease

Eculizumab

Recombinant monoclonal antibody approved for the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis

Lapatinib

4-anilinoquinazoline kinase inhibitor approved in combination with capecitabine for the treatment of advanced or metastatic breast cancer

Aliskiren

Oral renin inhibitor approved as monotherapy or in combination with other antihypertensive agents for the treatment of hypertension

Breast Cancer Patient Support Services

If your patients are considering hormonal treatment they can also register to receive materials that explain in detail the risk for breast cancer recurrence and how hormonal treatment works. This information will help your patients during your discussions about treatment options.

Breast Cancer Slide Atlas Now Available

The Breast Cancer Atlas brings you dozens of clinical, radiographic and histologic images that will transform your presentations and lectures. Each image is accompanied by expert information and perspectives on topical issues, written and reviewed by distinguished editors. With this tool you can select images for your use in presentations, save them in a personal folder, and receive the PowerPoint? file containing your selected images via e-mail.

Cancer Support Services: Hotline and Web Site

The AstraZeneca Cancer Support Network (AZ CSN) provides comprehensive, up-to-date medical and reimbursement information for AstraZeneca oncology products. The AZ CSN is available is available to patients and health care professionals.

Anastrozole after 2 years of tamoxifen demonstrates survival benefit

Postmenopausal women with hormone-sensitive early-stage breast cancer who have received at least 2 years of adjuvant treatment with tamoxifen can benefit in overall survival from a switch to anastrozole, according to the results of a meta-analysis published in the journal Lancet.

Drug Watch: Agents in late-stage development for the treatment of genitourinary disorders (March 2007) (PDF)

A review of agents in late-stage development for the treatment of genitourinary disorders (March 2007).

FDA proposes changes to ensure drug safety

The Institute of Medicine (IOM) issued a report in September 2006 urging FDA to make major changes to better balance the agency's assessment of the risks and benefits of new drugs. FDA commissioner Andrew von Eschenbach, MD, has responded with a report that details the agency's plans to improve procedures for detecting and assessing drug safety problems. "The Future of Drug Safety" describes proposals for developing safety "report cards" on new drugs to better inform prescribers and patients about new safety concerns and to more quickly detect drug safety signals.

RFID goes to work to help prevent errors, tampering

Due to pressure from regulators, the pharmaceutical industry is working to implement Radio Frequency Identification (RFID) technology in pharmacies, hospitals, and healthcare facilities to help prevent medication errors. This technology is also being used in a variety of ways to help meet FDA drug pedigree requirements.

Pramipexole: A nonergot-derived dopamine agonist for the treatment of restless legs syndrome

Drugs that act to increase dopamine activity are the mainstay of pharmacologic treatment for restless legs syndrome (RLS), a sensomotor disorder that usually manifests as an urge to move the legs, with or without other uncomfortable sensations.

A review of antithrombotic therapies in acute coronary syndrome: Should unfractionated heparin be replaced?

Cardiovascular disease afflicts more than 71.3 million people in the United States and accounts for more deaths annually than any other cause. The estimated direct and indirect costs associated with cardiovascular disease in 2006 ($403 billion) were more than double the costs associated with cancer ($190 billion), which is the second-leading cause of death in the United States.

Study sheds light on the 'Lazarus phenomenon'

Intra-arterial administration of thrombolytic therapy (mainly tissue-plasminogen activator [t-PA]) has demonstrated significant and immediate clinical improvement, dubbed the "Lazarus phenomenon," in about one-fourth of patients with acute ischemic stroke. Factors associated with the Lazarus phenomenon are a shorter time to treatment, a high reperfusion score, and formation of good pial collaterals.

Former FDA commissioners share ideas on strengthening the agency

A panel of former FDA commissioners convened recently to exchange ideas on improvements to the agency, tackling issues ranging from restructuring FDA funding to enhancing the agency's legal authority to ensure drug safety.

VTE prophylaxis with enoxaparin demonstrated to be superior to unfractionated heparin in acute stroke patients

Enoxaparin is superior to unfractionated heparin (UFH) for prevention of venous thromboembolism (VTE) in acute ischemic stroke patients with partial paralysis, according to David G. Sherman, MD, lead investigator of a trial known as PREVAIL (Prevention of VTE After Acute Ischemic Stroke with LMWH Enoxaparin).

State regulations help increase rate of t-PA treatment for acute ischemic stroke

Measures in Florida and Massachusetts that require paramedics to transport qualifying patients to certified stroke centers helped to increase the number of patients who received tissue plasminogen activator (t-PA) for the treatment of ischemic stroke in both states.

Community hospitals safely deliver t-PA for acute ischemic stroke

Emergency physician-directed treatment of patients with acute stroke using tissue plasminogen activator (t-PA) is as safe as treatment directed by an acute stroke team, according to the results of a retrospective study presented at the American Heart Association's (AHA's) International Stroke Conference 2007 in San Francisco, Calif.

Women may not achieve same cardiovascular benefits from statins as men

A meta-analysis published in the journal Current Medical Research and Opinion suggests that women may not achieve the same cardiovascular (CV) benefits from statins as men.

Meta-analysis suggests oral phenylephrine may be ineffective for nasal congestion as measured by nasal airway resistance

In a systematic review and meta-analysis published in the Annals of Pharmacotherapy, oral phenylephrine was demonstrated to be ineffective for the treatment of nasal congestion as measured by nasal airway resistance (NAR).

Posaconazole demonstrates efficacy for prophylaxis of fungal infections in certain patients

Two randomized, controlled trials published in the New England Journal of Medicine (NEJM) demonstrate that posaconazole may be considered a first-line option for prophylaxis of fungal infections in patients with severe graft versus host disease (GVHD) after allogeneic hematopoietic stem-cell transplantation as well as in immunosuppressed patients undergoing chemotherapy for acute myelogenous leukemia or the myelodysplastic syndrome.

Patients with severe COPD may benefit from the addition of an inhaled corticosteroid

In a randomized, double-blind, parallel-group trial published in the American Journal of Respiratory and Critical Care Medicine, the combination of fluticasone and salmeterol (SAL) statistically significantly reduced the number of chronic obstructive pulmonary disease (COPD) exacerbations by 35% compared with SAL alone.

Meta-analyses addressing antihypertensive drugs and incident diabetes bring answers and questions

Two studies published in the journals Lancet (Elliott et al) and the Archives of Internal Medicine (Barzilay et al) help to answer questions about the effect some antihypertensive agents can have on the development of diabetes mellitus, but these studies have also raised some new concerns about cardiovascular disease.

ADOPT weighs risks, benefits of 3 commonly used oral drugs to treat type 2 diabetes

In a multi-center, randomized, double-blind, controlled trial, use of rosiglitazone in patients with type 2 diabetes was found to delay the progression to monotherapy failure (fasting plasma glucose >180 mg/dL) more effectively than using metformin or glyburide.

Bivalirudin provides equal efficacy, lower risk of bleeding compared with current standard of care for ACS

In a large, multi-center, randomized, open-label, prospective trial named the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial, monotherapy with the anti-thrombotic agent bivalirudin, when administered to patients experiencing an acute coronary syndrome (ACS) (eg, unstable angina or myocardial infarction without ST-segment elevation), was demonstrated to be as efficacious as the current standard-of-care therapy but with nearly a 50% lower risk of bleeding. The results of the trial were published in the New England Journal of Medicine (NEJM).