Formulary Watch |

Public Citizen requests bans on Arava, Meridia

From Consumer Advocy Groups:Public Citizen urges ban on Arava. . . According to Public Citizen, 130 cases of severe liver toxicity-including 56 hospitalizations and 12 deaths-have been reported to the FDA since the 1998 introduction of rheumatoid arthritis agent leflunomide (Arava). This equates to six times the number of cases of fatal liver toxicity seen with methotrexate, although 5.5 times more prescriptions for methotrexate were filled over the 3-year comparative period. Public Citizen also says that leflunomide has been associated with 12 cases of Stevens-Johnson syndrome (compared with none reported with methotrexate) and more reports of lymphoma and hypertension.

Milrinone for acute exacerbations of CHF: Routine use not recommended

Ratherthan shortening the hospital stay and improving clinical outcomes, a 48-hour infusion of milrinone was associated with increased early treatment failure-particularly due to the development of arrhythmias and hypotension-in patients hospitalized with acute exacerbations of chronic heart failure (CHF).

FDA Actions in Brief

as reported May 1, 2002

Longer is better for thromboembolism prophylaxis after cancer surgery

Enoxaparin (Lovenox) is typically used during hospitalization after orthopedic or abdominal surgery. Recent studies of its use after orthopedic surgery have shown that extending administration of the low-molecular-weight heparin after hospital discharge significantly reduces the frequency of deep-vein thrombosis (DVT). A new study confirms this is also the case for abdominal surgery for cancer, which carries a high risk of this complication.

Popular antidepression herb doesn't stand up in clinical trial-but an SSRI doesn't either.

Neither extracts of Hypericum perforatum (St. John's Wort) nor sertraline (Zoloft) tested in patients with major depressive disorder performed better than placebo in reducing patients' scores on a standard assessment of depression severity.

No advantage to omapatrilat over enalapril in heart failure . . .

The investigational vasopeptidase inhibitor omapatrilat is as effective as enalapril in preventing major adverse cardiac outcomes in patients with moderate to severe heart failure, but failed to show superiority, said Milton Packer, MD.

ACC Pearls in Brief

LIPS: Statin reduces cardiac event risk by 22% in first PCI procedureAzithromax ineffective for reducing recurrent CV events

Thrombolytics after acute myocardial infarction (MI) may not be goodfor elderly patients.

Even when very elderly (age 80 years and older)patients have no contraindications to thrombolytic therapy, treatment withthese drugs can increase their risk of death.

Pipeline Preview for May

as reported May 1, 2002

Primary strategy in atrial fibrillation: Rate control is as acceptableas rhythm control

Drug therapy to control heart rate is at least as effective as antiarrhythmicdrug therapy in preventing adverse clinical events in patients with atrialfibrillation (AF), according to separate studies.

Cardiac events: Losartan beats beta blocker in patients with diabetes,HTN, & LVH

Therapy starting with the angiotensin receptor blocker (ARB) losartansignificantly reduced the risk of cardiovascular outcomes and new-onsetdiabetes compared with a beta blocker in older high-risk hypertensive patients,said Björn Dahlöf, MD. The improved outcomes with losartan occurredeven after adjusting for small differences in blood pressure reduction betweenthe two study drugs.

Outcomes in ACS: GP IIb/IIIa inhibitor plus LMWH superior to GPs plus unfractionated heparin

Atlanta-The low-molecular-weight heparin enoxaparin improves outcomes compared with currently recommended therapy in patients with non-ST-segment elevation acute coronary syndromes (ACS) who are being treated with a glycoprotein (GP) IIb/IIIa inhibitor, said Shaun Goodman, MD.

Lercanidipine: A long-acting dihydropyridine calcium channel blocker for treatment of hypertension

Lercanidipine is currently under FDA review for the management of hypertension. In comparative clinical trials, lercanidipine has shown antihypertensive efficacy comparable to that of slow-release nifedipine, amlodipine, nitrendipine, verapamil, captopril, and atenolol. Its side effect profile is similar or superior to these agents. This Focus article reviews those trials as well as lercanidipine?s pharmacologic properties and addresses the agent?s potential role in patients with comorbid conditions.

Part one of a two-part series: Beyond depression: Evaluation of newer indications and off-label uses for SSRIs (PDF)

Although selective serotonin reuptake inhibitors (SSRIs) are prescribed most often for depression disorders, they are increasingly being used to treat a variety of other conditions. In this article, the authors assess the evidence on anxiety disorders—generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, and social phobia. For each condition, they present the rationale for SSRI use, the degree of supportive clinical trial evidence, indication-specific dosing and safety considerations, and their recommendations for the preferred and alternative SSRIs.

Ezetimibe added to a statin results in greater LDL reduction

Adding the investigational cholesterol absorption inhibitor ezetimibe to statin therapy results in additional reductions in low-density lipoprotein (LDL) cholesterol of up to 14%.

Pharmacy pricing dominates policy agenda, but little real action has occurred so far

There is is a rising chorus in Washington and across the nation for action to control increased prescription drug expenditures.

American Psychiatric Association updates guidelines for bipolar disorder

The American Psychiatric Association has issued updated guidelines for the treatment of patients with bipolar disorder. The guidelines were last updated in 1994.

Health systems/plans share common coverage vision for Clarinex, OTC Claritin

Last month the FDA's Nonprescription Drugs Advisory Committee unanimously supported loratadine's (Claritin, Schering-Plough) switch from prescription to over-the-counter status for treatment of chronic idiopathic urticaria, moving the drug one step closer to full OTC status (see significant event timeline in sidebar).

First Time Generics

First time generics

Atopic Dermatitis: Disease Overview and the Development of Topical Immunomodulators (PDF)

Atopic dermatitis is a chronic, recurrent skin disease characterized by intense pruritis (itching) and inflammation. This supplement which was produced through an unrestricted educational grant from Fujisawa Healthcare, Inc. provides you with an overview of the disease and the development of Topic Immunomodulators. The views and opinions expressed in this supplement do not necessarily reflect the views of Formulary.

Pharmacy card programs proliferate as generics policy, user fees gain center stage

While the Bush administration persists in promoting a Medicare RxDrug Card plan, pharmaceutical companies continue to unveil their own versions.

Simple physician-prompting intervention drastically improves outcomes in CHD

Creighton University, Omaha, NE-Despite the evidence that lipid-lowering drug therapy-especially with HMG-CoA reductase inhibitors (statins)-is known to save lives and help prevent subsequent events in coronary heart disease (CHD) patients, utilization of this class of drugs is erratic.

LYMErix (Lyme disease vaccine)

Withdrawn: Vaccine discontinued due to poor sales

Zometa (Zoledronic acid for injection), Novartis

New indication: Bisphosphonate cleared for multiple myeloma, metastases of solid tumors

Zoledronic acid

New indication: Bisphosphonate cleared for multiple myeloma, metastases of solid tumors.

Zevalin (Ibritumomab tiuxetan)

New biologic: Radioimmunotherapeutic for non-Hodgkin's lymphoma

Rebif (Interferon beta-1a)

New biologic: Second interferon beta-1a product for relapsing multiple sclerosis

FDA Actions in Brief

as reported April 1, 2002

Pipeline Preview

(as reported April 1, 2002)

New ACC/AHA guidelines reshape drug therapy for acute coronary syndromes

Prompted by a flurry of new evidence, two leading cardiology groups have revised their guidelines for the management of acute coronary syndromes just 18 months after the last revision.