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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).

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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.

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).

FDA actions in brief

FDA approved 3 mg drospirenone/20 mcg ethinyl estradiol (Yaz, Berlex) for the treatment of moderate acne vulgaris in women who desire an oral contraceptive for birth control. This agent was previously approved for oral contraception and for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder in women who desire an oral contraceptive.

Mesalamine

Once-daily oral formulation of anti-inflammatory agent approved for the induction of remission in patients with active, mild-to-moderate ulcerative colitis

Strategies for the management of insomnia: An update on pharmacologic therapies

Many Americans suffer from insomnia regularly, but clinicians often do not address this issue. A variety of factors may contribute to insomnia, including medical conditions such as gastroesophageal reflux disease, Parkinson disease, and heart failure. Medications such as amphetamines, theophylline, and beta agonists could also precipitate insomnia.

Tolterodine ER plus tamsulosin demonstrates benefit in men with lower urinary tract symptoms, overactive bladder

Combination therapy with an antimuscarinic agent (tolterodine extended release [ER]) and alpha1-receptor antagonist (tamsulosin) provided symptomatic benefit in men with moderate-to-severe lower urinary tract symptoms and overactive bladder, according to a large-scale, randomized, double-blind, placebo-controlled study published in the Journal of the American Medical Association (JAMA).

Strategies for the management of insomnia: An update on pharmacologic therapies

Many Americans suffer from insomnia regularly, but clinicians often do not address this issue. A variety of factors may contribute to insomnia, including medical conditions such as gastroesophageal reflux disease, Parkinson disease, and heart failure. Medications such as amphetamines, theophylline, and beta agonists could also precipitate insomnia.

FDA releases proposals for PDUFA IV; federal report addresses cost of drug development

A public forum scheduled this month will help to solidify proposals FDA unveiled in January for reauthorization of the Prescription Drug User Fee Act (PDUFA). Once public comment from the February 16 meeting is received and incorporated into the finalized proposal, negotiations between the agency and the federal government over the fourth incarnation of this important funding mechanism will be key in determining FDA's fiduciary future.

A critical look at prescription drug direct-to-consumer advertising

Direct-to-consumer advertising (DTCA) of prescription drugs has been a source of debate since its US approval by FDA in 1997. A primary source of debate among experts is the methods advertisers use to attempt to influence the consumer and the consumer's subsequent reaction. Despite the controversy, authors of a recent content analysis of televised DTCA say there has been no systematic analysis of DTCA's influence on consumers to date.

AGA issues consensus statement on the use of NSAIDs

The American Gastroenterological Association (AGA) has issued a consensus statement on the safe and efficacious use of nonsteroidal anti-inflammatory drugs (NSAIDs), including nonselective, nonsteroidal anti-inflammatory drugs (nsNSAIDs), cyclooxygenase-2 enzyme inhibitors (coxibs), and aspirin (ASA).

Sleep disturbance associated with SSRI use in older women

A cross-sectional study of selective serotonin reuptake inhibitor (SSRI) use by community-dwelling older women aged ≥71 years with or without depression demonstrated that SSRI use in that population was strongly associated with sleep disturbance. The study, which relied on data collected from 4 centers throughout the United States, was recently published in the Journal of the American Geriatrics Society.

Rifaximin considered as possible treatment for IBS

Rifaximin has demonstrated global improvement of the symptoms of irritable bowel syndrome (IBS) in patients for ≤10 weeks after the discontinuation of therapy. Rifaximin is a nonabsorbed (≤0.4%), broad-spectrum antibiotic that was approved by FDA in 2004 for travelers' diarrhea.

Aspirin may reduce the risk of newly diagnosed adult-onset asthma

A post-hoc analysis of the large, randomized, double-blind, placebo-controlled Physicians' Health Study found that the use of low-dose aspirin (ASA) on alternating days reduced the risk of adult-onset asthma by a statistically significant 22%.

FIT versus FLEX: Weighing the benefits of extending bisphosphonate therapy beyond 5 years

A randomized, double-blind, placebo-controlled trial published in the Journal of the American Medical Association (JAMA) found that women who discontinued alendronate after 5 years demonstrated a moderate decline in bone mineral density (BMD) and a gradual increase in serum markers of bone turnover compared with women who continued taking alendronate for an additional 5 years, but mean levels among patients who discontinued therapy remained at or above baseline levels measured 10 years earlier. In addition, no greater fracture risk other than for clinically detected vertebral fractures was seen in the discontinuation group compared with patients who continued alendronate for 10 years.