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Moxifloxacin associated with faster clinical recovery than levofloxacin in CAP treatment

A prospective, double-blind, randomized, controlled trial comparing the effectiveness of levofloxacin and moxifloxacin in treating community-acquired pneumonia (CAP) among 394 hospitalized elderly patients (aged 65 years and older) demonstrated that moxifloxacin resulted in faster recovery than levofloxacin.

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Advisory committee prompts FDA to consider black box warning for ADHD drugs

FDA officials are reviewing an unexpected recommendation from the agency's Drug Safety and Risk Management Advisory Committee to add black box warnings to attention deficit/hyperactivity disorder (ADHD) stimulant medications. In addition to advising the agency about clinical trial designs that could better assess cardiovascular risks associated with ADHD therapies, members of the advisory committee called for immediate action to caution prescribers and patients about potential adverse events associated with these drugs. Concerns about increased risk of myocardial infarction, stroke, and sudden death have emerged with increased prescribing of stimulant ADHD drugs for adults and children?an estimated 4 million patients use these mediations, including more than 1 million adults.

Aprotinin may increase risk in cardiac surgery; FDA issues alert

The serine protease inhibitor aprotinin (Trasylol, Bayer) may increase the risk of renal failure, myocardial infarction, heart failure, stroke, and encephalopathy among patients undergoing coronary artery bypass graft (CABG) surgery, according to an observational study in the New England Journal of Medicine (NEJM).

FDA actions in brief

Hepatitis B immune globulin (HepaGam B, Cangene) was approved for the treatment of acute exposure to blood containing the hepatitis B surface antigen (HbsAg), perinatal exposure of infants born to mothers who are positive for HbsAg, sexual exposure to individuals who are HbsAg-positive, and household exposure to individuals with acute HBV infection.

Amitiza

By increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby increasing the passage of stool and alleviating symptoms associated with constipation. Lubiprostone was approved on January 31, 2006, for the treatment of chronic idiopathic constipation (CIC) in adults.

Ranexa

The anti-anginal and anti-ischemic properties of ranolazine are not dependent on reductions in heart rate or blood pressure. Ranolazine was approved on January 27, 2006, for the treatment of chronic angina. Because ranolazine prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other anti-anginal drugs.

Medicare encourages more drug effectiveness information

The Medicare Prescription Drug Plan, which began January 1, 2006, makes the federal government the largest purchaser of pharmaceuticals in the United States, and probably in the world. It is projected that the Centers for Medicare and Medicaid Services (CMS) will spend more than $1 trillion on medications over the next decade, a volume that will influence the pharmaceutical market more broadly and generate new initiatives to encourage utilization of more cost-effective treatments.

A growth hormone conversion program and patient outcomes at a not-for-profit HMO

Although experience tells us that formulary conversion programs are commonplace, they are discussed fairly infrequently in the literature. A recent MEDLINE search did not identify any conversion programs similar to a human growth hormone (HGH) program implemented at HIP Health Plan of New York (HIP-NY).

Influence of a UTI empiric treatment pathway on physician prescribing in an academic medical center

In an attempt to improve patient outcomes and control costs, a guide to empiric antimicrobial therapy, including a urinary tract infection (UTI) algorithm, was distributed to hospital physicians at an academic medical center. A retrospective study was conducted to assess the impact of the guide on physician prescribing of empiric antimicrobial therapy for UTIs. Prior to the implementation of the guide, 45% (n=55) of patients with UTIs were treated consistently with the algorithm. Although not statistically significant, consistency increased to 51% (n=45) after implementation of the guide. The initial publication of a guide to empiric antimicrobial therapy did not significantly influence physician prescribing patterns regarding UTIs. Educational sessions at the time of implementation along with reinforcement of the guidelines may further impact prescribing habits and influence algorithm compliance.

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Approvable designations, Fast-track designations

FDA actions in brief

FDA approved ranolazine extended-release tablets (Ranexa, CV Therapeutics) on January 31, 2006, for the treatment of chronic angina. A more thorough review of the agent will appear in the FDA Drug Approvals section of Formulary's March issue.

Exubera

New inhalable insulin formulation approved

Sutent

Kinase inhibitor approved for GIST and advanced renal cell carcinoma

Economic analysis of a medication assistance program for ambulatory care patients at an urban teaching clinic

Objective: Pharmacy-managed medication assistance programs (MAP) have the potential to recoup losses incurred by the pharmacy department, but whether this offsets the personnel cost of the program has not been well-established. The purpose of this study was to conduct a cost-benefit analysis of the pharmacy-managed MAP at an urban teaching clinic at Hartford Hospital in Hartford, Conn.

FDA actions in brief

Oxcarbazepine (Trileptal, Novartis) was approved as adjunctive therapy to treat partial seizures in children aged 2 years or older with epilepsy.

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Methylphenidate transdermal patch (Daytrana, Shire/Noven) to treat attention-deficit/hyperactivity disorder (ADHD)