Formulary Watch |

Anticoagulant bridging: Prosthetic heart valves, labeling changes, and limiting issues of liability

With enoxaparin?s recent labeling change regarding its use in patients with prosthetic valves, clinicians may have several questions about appropriate anticoagulant selection. Specifically, what evidence prompted the labeling change, which patients are affected, what are the options and limitations for bridging patients, what?s the evidence supporting the role of low molecular weight heparins (LMWHs) in bridge therapy, and how can liability be limited should clinicians choose to use LMWH therapy? The authors of this commentary offer their insight on these issues.

Senate backs legislation easing access to generic drugs and to cheaper imports

Instead of adopting a Medicare pharmacy benefit plan in July, the Senate approved legislation designed to make pharmaceuticals less expensive for all consumers. The House and Senate, however, remain far from agreement on any final legislation involving pharmaceutical coverage and regulation, and time is running out for action before the Congressional elections this November.

Diovan (Valsartan) Novartis

ARB now indicated for heart failure

Voriconazole: A novel azole antifungal agent (PDF)

In late May, voriconazole (Vfend) received approval for the treatment of invasive aspergillosis and as salvage therapy for treatment of Scedosporium apiospermum and Fusarium infections. In addition to these infections, voriconazole has excellent invitro activity against both Candida and Aspergillus species, including good activity against fluconazole- and itraconazole-resistant species. This Focus article reviews the antifungal's pharmacology, pharmacokinetics, efficacy in clinical trials, safety, dosing, price, and place in therapy.

Understanding the costs and treatments of alcohol abuse and dependence (PDF)

Effective decision-making in benefit management requires an understanding of the economic burden of an illness - in this case, the economic burden and treatment of alcoholism. This article provides an understanding of the true costs of the disease, what has been found to be effective in its treatment, and what treatments may lessen the economic burden of the disease.

The guideline development process: One organization's experience with a guideline for stable COPD (PDF)

Finding optional ways to manage patients with chronic obstructive pulmonary disease (COPD) - the fourth leading cause of death in the US became a priority for this large mid-western collaborative of health care organizations. This this end, a guideline was developed to help clinicians identify, evaluate and manage COPD. This article provides an overview of the guideline development process and implementation approach, key guideline components, and the step-by-step pharmacologic treatment strategy.

Congress expands drug safety surveillance as part of bioterrorism bill

Just before leaving Washington for the Memorial Day recess in May, Congress approved legislation to enhance the ability of hospitals and public health agencies to respond to bioterrorist threats.

Infliximab could provide new long-term option for Crohn's disease

Patients with Crohn's disease who show an initial response to a single dose of infliximab (Remicade) are more likely to remain in remission a year later if therapy is maintained every 8 weeks, say these researchers.

Did naproxen's cardioprotective effect skew safety data on rofecoxib?

Three case-controlled studies published in the Archives of Internal Medicineshow naproxen sodium has cardioprotective effects that other NSAIDs don't.An accompanying editorial says that no evidence indicates that the COX-2inhibitor rofecoxib increases (or decreases) MI risk. It simply fell victimto being compared with the only NSAID (ie, naproxen) shown to have a cardioprotectivebenefit. (None of these new studies directly compared non-naproxen NSAIDswith COX-2 inhibitors.)

Congress expands drug safety surveillance as part of bioterrorism bill

Just before leaving Washington for the Memorial Day recess in May, Congress approved legislation to enhance the ability of hospitals and public health agencies to respond to bioterrorist threats. A key addition to the bill reauthorizes the Prescription Drug User Fee Act (PDUFA) for 5 years so that the Food and Drug Administration will continue to accelerate development and approval of new drugs.

Tegaserod meta-analysis: Global relief of IBS symptoms, no increase in abdominal surgery

Tegaserod, an investigational serotonin receptor agonist, provides global relief of the symptoms of constipation-predominant irritable bowel syndrome (IBS) with an acceptable incidence of adverse events, according to the results of meta-analysis of four phase III trials presented at Digestive Disease Week in San Francisco.

FDA Actions in Brief

FDA actions in Brief

Pipeline Preview for July

Pipeline Preview as reported July 1, 2002

Neurontin (Gabapentin) Pfizer Inc.

New Indications: First approval of oral treatment for postherpetic neuralgia

Vfend (Voriconazole) Pfizer Inc.

NME: Option for life-threatening fungal infections

Remodulin (Treprostinil sodium injection) United therapeutics corp.

NME: Approved for all symptomatic stages of pulmonary arterial hypertension

NEW WARNING: Simvastatin: Myopathy risk

New labeling for the cholesterol-loweringagent simvastatin (Zocor, Merck) highlights the risks of myopathyand rhabdomyolysis with or without acute renal failure as side effectsof the drug alone or in combination.

NEW WARNING: Clinicians alerted to Seroquel/Serzone confusion

Confusion between two drugs with sound-alike proprietary names, the antipsychotic quetiapine fumarate (Seroquel, AstraZeneca) and antidepressant nefazodone HCl (Serzone, Bristol-Meyers Squibb) has prompted AstraZeneca to send a "Dear Healthcare Professional" letter warning of the potential mix-up.

NEW WARNING: Uterine sarcoma linked with long-term tamoxifen use

Cases of uterine sarcoma in women receiving tamoxifen citrate (Nolvadex, AstraZeneca) have prompted a "Dear Health Professional" letter, black-box warnings on labeling, and publication of a letter to the editor in the New England Journal of Medicine from FDA officials.

NEW WARNING: Baclofen black box warns against abrupt discontinuation.

A black-boxwarning added to baclofen's (Lioresal Intrathecal, Med-tronic) labelingwarns against abrupt discontinuation of the drug.

LABELING UPDATE: CLASS study, updated GI, CV risk info, added to celecoxib label

Safety information from the Celecoxib Long-term Arthritis Safety Study (CLASS)on GI and cardiovascular events has been included in safety labeling forcelecoxib (Celebrex, Searle).

Liver toxicity risk low with rosiglitazone

Ever since troglitazone was pulled from the market because of hepatotoxicity,clinicians has been concerned that this may be a class effect. But a newstudy of rosiglitazone (Avandia), funded by manufacturer SmithKlineBeecham,indicates this drug is not associated with heptatotoxic effects.

Early statin use after MI may increase second-event risk for some

Previous observational studies found that starting statins early after an MI reduces the risk of second heart attacks and death. But a new, larger observational study published last month in JAMA found no such reduction with early initiation (< 7 days)-and even an increased risk of MI or death for patients whose cholesterol levels were below treatment guideline levels.

No link between hepatitis B vaccine and neurologic disorders

The evidence doesn't support a link between administration of hepatitis B (HPB) vaccine and demyelinating disorders, such as multiple sclerosis (MS) and Guillain-Barré syndrome, so no change in immunization policy is warranted, according to an Institute of Medicine (IOM) report.

Multiple studies show eplerenone to be a potent antihypertensive agent

Eplerenone, a selective aldosterone inhibitor in phase III clinical trials,is an effective agent for reducing blood pressure in a variety of patientswith hypertension, including African-Americans, said presenters at the 17thannual scientific meeting of the American Society of Hypertension in NewYork City.

No decline in GI cotherapy or healthcare costs with switch to COX-2 selective drugs

Switching from traditional nonsteroidal anti-inflammatory drugs (NSAIDs) to COX-2 selective drugs does not result in a decrease in gastrointestinal (GI) medical cotherapy. Furthermore, there is no reduction in GI healthcare costs when patients are switched from NSAIDs to selective COX-2 inhibitors, said Loren Laine, MD, at Digestive Disease Week in San Francisco.

The six-step process for conducting outcomes analyses using administrative databases (PDF)

Administrative databases are a potentially useful source of data for conducting retrospective studies. Information in such a database can be used to evaluate the effects of organizational policy changes, new programs, or pharmaceutical therapies. This month?s column reviews the six essential steps required for conducting a simple database analysis. An example involving sepsis is used to further illustrate key points.

Alefacept: A T-cell-specific immunosuppressant to treat moderate to severe plaque psoriasis (PDF)

Alefacept (Amevive) is the first immunosuppressive agent directed specifically at inhibiting the activation of, and possibly killing, T cells, which are involved in the cascade of events leading to psoriatic plaque formation and inflammation. In May, an FDA advisory committee recommended alefacept for approval as a first-line therapy against moderate to severe plaque psoriasis. The authors of this Focus article review the clinical characteristics of alefacept as well as make comparisons with other systemic drugs currently used to treat chronic psoriasis and the likely biologic competitors etanercept and infliximab.

Beyond hypertension: Evidence for use of angiotensin II receptor blockers in renal dysfunction and heart failure (PDF)

The evidence supporting a role for the angiotensin II receptor blockers (ARBs) in patients with nephropathy and/or heart failure continues to evolve. Currently, the FDA is in late-stage review of the first ARB for a heart failure indication and is reviewing another ARB for a diabetic nephropathy indication. The authors of this article present and interpret the clinical evidence for ARB use in these two disease states. Included in their discussion are the most recent recommendations on ARBs’ place in therapy according to the American Diabetes Association, the American College of Cardiology, and the American Heart Association.

Market share shift analysis identifies potential impact of atypical antipsychotic formulary addition on budget

Anoka Regional Treatment Facility, Anoka, MN-This 150-bed regional treatment facility was spending over half its annual budget on atypical antipsychotic medications. In an effort to better control rising drug class costs, a market share shift analysis of the products currently in use at the facility was conducted.