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.
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Once-daily oral formulation of anti-inflammatory agent approved for the induction of remission in patients with active, mild-to-moderate ulcerative colitis
Sterile, lyophilized powder concentrate of antihemophilic factor and von Willebrand factor complex for surgical and/or invasive procedures in patients with von Willebrand disease
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.
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).
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.
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.
Researchers at the Infectious Disease Laboratory at Columbia University Mailman School of Public Health and the World Health Organization (WHO) Global Laboratory Network have developed a new diagnostic tool called the "GreeneChip," a glass slide that can rapidly and accurately identify multiple pathogens from different biologic samples (eg, tissue, blood, urine).
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.
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).
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.
Adverse events associated with the use of atypical antipsychotic medications in the management of psychosis, aggression, and agitation in patients with Alzheimer's disease (AD) may outweigh any benefit the treatments provide, according to a double-blind, placebo-controlled study published in the New England Journal of Medicine (NEJM).
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.
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%.
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.
The duration of dual antiplatelet therapy (aspirin plus clopidogrel) following drug-eluting stent (DES) implantation has been a source of much recent debate. FDA currently recommends either 3 or 6 months of clopidogrel therapy following DES implantation, depending on the type of stent used.
In a large, nested case-control study published in the Journal of the American Medical Association (JAMA), proton pump inhibitor (PPI) use was demonstrated to be associated with a 44% to 165% increase in the risk of hip fracture in patients aged >50 years.
Concern over possible valvulopathy with the use of certain ergot-derived dopamine agonists is further supported by 2 studies published in The New England Journal of Medicine (NEJM) regarding the incidence of cardiac-valve regurgitation in patients taking these types of drugs, which are FDA-approved to treat Parkinson disease and hyperprolactinemia and sometimes used off-label to treat restless legs syndrome.
An estradiol transdermal gel (Elestrin [formerly Bio-E-Gel], Bradley/BioSante) was approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
Methscopolamine tablets, 2.5 mg (equiv to Pamine tablets)
Approvable designations; Nonapprovable designation; Fast-track designation; Priority review; Orphan drug designations
Intramuscular injectable formulation of atypical antipsychotic approved for the treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed
Incretin mimetic approved as adjunctive therapy in type 2 diabetes mellitus not adequately controlled by a thiazolidinedione
Antibiotic approved for the prophylaxis of surgical site infection following elective colorectal surgery
A review of agents in late-stage development for the treatment of hepatitis (February 2007)
