Formulary Watch |

FDA revises drug labels to clarify information for health professionals

FDA began 2006 by unveiling a long-anticipated final rule that significantly overhauls approved labeling for drugs and biologics. This new rule has been in the works for years, delayed by manufacturer concerns that the revisions will expose companies to more liability suits. Although the new labeling's basic framework came as no surprise, compliance will require significant investments by manufacturers to meet the new design and content requirements, which will double the length of many package inserts (PIs).

Single-day famciclovir shortens duration of genital herpes outbreaks

A single day of famciclovir started within 6 hours of a genital herpes outbreak shortens the duration of recurrent genital herpes lesions, said Fred Y. Aoki, MD, at the 45th ICAAC meeting in Washington, DC.

ICAAC 2006: Physicians warn of overuse of vancomycin in treating hospital-acquired pneumonia

Vancomycin may be overused for the treatment of hospital-acquired pneumonia, perhaps because of physicians' perceptions that patients are at high risk for methicillin-resistant Staphylococcus aureus (MRSA), according to a study by Robert H. Eng, MD, and colleagues at the Veterans Affairs New Jersey Health Care System in East Orange, NJ. The study was presented at the 45th ICAAC meeting in Washington, DC.

ICAAC 2006: Gastric acid-suppressive drugs linked to C difficile infection

The use of acid-suppressive drugs, particularly proton pump inhibitors (PPIs), was associated with an increase in the risk of community-acquired Clostridium difficile-associated disease (CDAD) in the United Kingdom, reported Sandra Dial, MD, MSc, at the 45th ICAAC meeting in Washington, DC.

Patient adherence increases then tier 1 or 2 medications are prescribed by physicians

A study analyzing pharmacy claims among patients who receive chronic medications via 3-tier prescription drug plans found that patients who were prescribed generic or preferred medications by their physicians were the most likely to adhere with their treatments.

Statin therapy benefits ACS patients with low LDL-cholesterol levels

A study of 155 patients examining the effects of statins on patients diagnosed with acute coronary syndrome (ACS) suggests that statin therapy may increase survival rates and potentially extends the results of larger, recently performed randomized trials to those with low-density lipoprotein cholesterol (LDL-C) levels of 80 mg/dL and below.

Abatacept demonstrates efficacy in place of TNF-alpha inhibitors

Rheumatoid arthritis patients, hindered by an inadequate response to tumor necrosis factor-alpha (TNF-alpha) inhibitors, may find some relief in the form of a drug that belongs to a new class of selective costimulation modulators.

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.

Topiramate safely decreases body mass hypertension

Topiramate safely decreases body mass, hypertension. Topiramate reduces body weight and blood pressure with generally mild-to-moderate adverse effects, according to a randomized, placebo-controlled trial involving obese subjects with hypertension.

Meta-analysis concludes statins have no effect on cancer risk

A recent meta-analysis published in the Journal of the American Medical Association (JAMA) found that statins have no effect on cancer risk. The finding is in contrast with at least 7 retrospective analyses that suggest that statins reduce the risk of developing cancer.

Colesevelam/fenofibrate combination boosts efficacy in treatment of hyperlipidemia

Colesevelam/fenofibrate combination boosts efficacy in treatment of hyperlipidemia. Fenofibrate significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients with mixed hyperlipidemia when used in combination with the specifically engineered bile acid sequestrant (SE-BAS) colesevelam, according to a study published in Current Medical Research and Opinion.

Trastuzumab improves survival, outcomes of HER2-positive breast cancer patients

Two recent studies in The New England Journal of Medicine (NEJM) focused on the breast cancer drug trastuzumab, a recombinant monoclonal antibody (Herceptin, Genentech/Roche).

Intensive control of type 1 diabetes results in fewer cardiovascular events over the long term

Tight glucose control for a mean period of 6.5 years produces long-lasting cardiovascular benefits in patients with type 1 diabetes, according to a study published in the New England Journal of Medicine (NEJM).

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.

First-time generic approvals

Isradipine capsules 2.5 and 5 mg (equiv to Dynacirc capsules)

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.

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Drug Watch: Agents in late-stage development for the treatment of Parkinson disease (March 2006) (PDF)

A review of agents in late-stage development for the treatment of Parkinson disease (March 2006).

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.

Focus On: Dalbavancin A novel long-acting lipoglycopeptide antibiotic

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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

Drug Watch: Agents in late-stage development for the treatment of ophthalmic disorders (February 2006) (PDF)

A review of agents in late-stage development for the treatment of ophthalmic disorders (January 2006)