Abstract:
:In August 2015, the US Food and Drug Administration (FDA) made the controversial decision to approve flibanserin (Addyi®) for women experiencing hypoactive sexual desire disorder. A number of factors contributed to disagreements regarding the FDA's decision, including the product's two prior failed FDA reviews, the unmet need of women with this disorder, extensive advocacy and politicization surrounding the product's relevance to women and sexual health, the potential for widespread off-label use, and the product's tenuous risk/benefit profile. Despite that, attention now shifts to maximizing the safe use of the product, including the optimal means to avoid numerous drug-drug interactions as well as the concomitant use of alcohol, both of which potentiate the risks of dizziness, hypotension, and syncope. Although the FDA has implemented a comprehensive Risk Evaluation and Mitigation Strategies program to maximize the product's safe use, patients, clinicians, and regulators must exhibit heightened vigilance early in the product's post-market life.
journal_name
Drug Safjournal_title
Drug safetyauthors
Baksh SN,Gellad WF,Alexander GCdoi
10.1007/s40264-015-0389-2subject
Has Abstractpub_date
2016-05-01 00:00:00pages
375-80issue
5eissn
0114-5916issn
1179-1942pii
10.1007/s40264-015-0389-2journal_volume
39pub_type
杂志文章相关文献
DRUG SAFETY文献大全abstract::Paraquat is a bipyridyl compound with no known chronic toxicity or teratogenicity. It is poorly absorbed when inhaled, but causes severe illness when ingested orally, death usually occurring within 2 days of ingestion of 50 mg/kg. At lower doses death may be delayed for several weeks. The toxic compound accumulates in...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199005040-00002
更新日期:1990-07-01 00:00:00
abstract::Menorrhagia affects the lives of many women. The assessment of menstrual flow is highly subjective and gauging the severity of the condition by objective assessment of menstrual blood loss is impractical. In treating menorrhagia, the primary aim should be to improve quality of life. Women are willing to undergo quite ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200427020-00001
更新日期:2004-01-01 00:00:00
abstract::Cirrhosis encompasses a range of pathophysiological changes that may alter drug disposition. Drugs that are dependent primarily on the liver for their systemic clearance are more likely to be subject to reduced elimination and subsequent accumulation. Drug accumulation may lead to excessive plasma drug concentrations ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199717010-00004
更新日期:1997-07-01 00:00:00
abstract::The development of antiretroviral therapy (ART) has dramatically increased the lifespan of HIV patients but treatment is complicated by numerous adverse effects and toxicities. ART complications include neuropsychiatric, metabolic, gastrointestinal, cardiac, and numerous other toxicities, and clinicians often have to ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-016-0440-y
更新日期:2016-10-01 00:00:00
abstract:BACKGROUND:Newly approved drugs, in comparison with older drugs, are more often prescribed to patients who have not responded satisfactorily to established related drugs or as first-line therapy to patients with a high baseline risk for adverse outcomes (i.e. channelling). However, these patients are less likely to ben...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200831020-00004
更新日期:2008-01-01 00:00:00
abstract::Complex interactions exist amongst the various components of the neuroendocrine system in order to maintain homeostasis, energy balance and reproductive function. These components include the hypothalamus-pituitary- adrenal and -gonadal axes, the renin-angiotensin-aldosterone system, the sympathetic nervous system and...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200730030-00005
更新日期:2007-01-01 00:00:00
abstract::The aim of this review is to analyse and summarise the literature data about the incidence of weight gain in patients exposed to atypical antipsychotics during long-term (>or=1 year) treatment regimens. Despite the clinical relevance of the topic, the vast majority of reviewed studies showed methodological limitations...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200629040-00002
更新日期:2006-01-01 00:00:00
abstract::Several anticancer drugs have been associated with cardiac toxicity, especially the anthracyclines and trastuzumab. The pathogenesis of anthracycline-associated toxicity has been well described, whereas the mechanism of trastuzumab-associated toxicity is unknown. Although routine cardiac imaging studies (e.g. echocard...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200225050-00001
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND:The tumour necrosis factor-alpha inhibitor infliximab is incorporated in the treatment guidelines for patients with inflammatory bowel disease (IBD). However, concerns about serious adverse events such as infections, malignancies and death do exist. OBJECTIVE:To evaluate the occurrence of serious events of ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/0002018-200831120-00009
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Rosuvastatin is a lipid-lowering drug, the newest of a class of drugs called HMG-CoA reductase inhibitors, or 'statins', launched in the UK in March 2003. Our objective was to monitor the post-marketing safety of this drug, prescribed in primary care in England, using prescription-event monitor...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200730020-00005
更新日期:2007-01-01 00:00:00
abstract:INTRODUCTION:Controversy exists about an association between angiotensin-converting-enzyme inhibitors (ACEIs), angiotensin-receptor blockers (ARBs), and thiazides (TZs) and the risk of malignant melanoma (MM), and non-melanoma skin cancer-basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). OBJECTIVE:The aim ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0487-9
更新日期:2017-03-01 00:00:00
abstract::The development of in vitro models is advancing rapidly, with the application of cell culture methods as an alternative to animals in toxicological screening; non-cellular systems are also being used. Any screening test, whether for detecting irritants, carcinogens or teratogens should be well validated against known ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199000051-00006
更新日期:1990-01-01 00:00:00
abstract:BACKGROUND:Clozapine is an antipsychotic medication associated with a lower suicide rate compared with other antipsychotic agents. Clozapine is used specifically in patients for whom previous therapy was inadequate or not tolerated, and is the only antipsychotic agent associated with the development of myocarditis. OB...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200730010-00005
更新日期:2007-01-01 00:00:00
abstract::Benzodiazepine drugs have been shown to suppress respiratory function in patients with chronic obstructive pulmonary disease (COPD). We designed a placebo-controlled crossover study to compare the effects of a new benzodiazepine, estazolam ('ProSom'), with those of flurazepam ('Dalmane') on cardiopulmonary function in...
journal_title:Drug safety
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.2165/00002018-199207020-00006
更新日期:1992-03-01 00:00:00
abstract::Probiotics have seen widespread use for a variety of gastrointestinal problems, especially in two common disorders: irritable bowel syndrome and inflammatory bowel disease. Since a wide variety of probiotic preparations has been used, and despite a large number of studies performed, a great deal of heterogeneity exist...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-015-0349-x
更新日期:2016-04-01 00:00:00
abstract:INTRODUCTION:Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme....
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0502-1
更新日期:2017-05-01 00:00:00
abstract::Bisphosphonates are the primary pharmacological agents used for the management of osteoporosis and hypercalcaemia of malignant bone disease. The efficacy of these agents in these two conditions has been demonstrated in many well designed trials published over the past 2 decades. The variety of bisphosphonates currentl...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200629120-00005
更新日期:2006-01-01 00:00:00
abstract::Randomised clinical trials offer a unique opportunity for capturing safety information under a controlled setting that minimises biases in the comparison of different therapeutic options. Nevertheless, empirical evidence across diverse medical fields suggests that the reporting of safety information in clinical trials...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200225020-00002
更新日期:2002-01-01 00:00:00
abstract::Pharmacotherapy in pregnant women is often necessary to treat chronic or relapsing depression or anxiety disorders. Studies that have evaluated the safety of selective serotonin reuptake inhibitors (SSRIs) in early pregnancy have not shown an enhanced risk of major congenital malformations and these results may have c...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200528070-00002
更新日期:2005-07-01 00:00:00
abstract::The US FDA has issued safety alerts and required manufacturers of leukotriene-modifying agents (LTMAs), including montelukast, zafirlukast and zileuton, to include suicide and neuropsychiatric events as a precaution in the drug label. This paper reviews the existing evidence on the potential association between the LT...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/11587260-000000000-00000
更新日期:2011-07-01 00:00:00
abstract::The most frequently reported symptoms in heart failure are fatigue and dyspnoea, which limit exercise tolerance. However, several surveys reveal other changes in physical and psychological well-being which affect the patient's perception of 'quality of life'. The introduction of new treatments for heart failure has st...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199106040-00002
更新日期:1991-07-01 00:00:00
abstract:BACKGROUND:Spontaneous reporting of adverse drug reactions (ADRs) is fundamental to drug safety surveillance (pharmacovigilance); however, substantial under-reporting exists and is the main limitation of the system. Several factors could favour under-reporting. OBJECTIVE:The aim of this pilot study was to assess the e...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11319170-000000000-00000
更新日期:2010-05-01 00:00:00
abstract::Adverse drug effects are manifold and heterogenous. Many situations may hamper the signalling (i.e. the detection of early warning signs) of adverse effects and new signals often differ from previous experiences. Signals have qualitative and quantitative aspects. Different categories of adverse effects need different ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199716060-00002
更新日期:1997-06-01 00:00:00
abstract::Recent evidence from animal studies has raised the possibility that immunisation by vaccines can influence the pathogenesis of type I (insulin-dependent) diabetes mellitus. In non-obese diabetic mice and biobreeding rats, complete Freund's adjuvant and bacillus Calmette-Guérin (BCG) vaccine have successfully been used...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199920030-00001
更新日期:1999-03-01 00:00:00
abstract::The clinician prescribing beta-blockers for his or her patients is faced with an often difficult situation. There are many beta-blockers, each with its own pharmacological profile. Patients are often taking multiple medications, thus increasing the risk of both anticipated and unexpected drug interactions. Reports of ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199513060-00005
更新日期:1995-12-01 00:00:00
abstract::Iodinated contrast media (CM) are an integral part of modern diagnostic medicine. Although these agents are considered to be relatively safe, adverse effects in the form of allergy-like reactions occur in a significant number of exposed patients. These reactions may be divided into immediate and delayed responses. Imm...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200629020-00003
更新日期:2006-01-01 00:00:00
abstract::Adoptive T cell therapy (ACT) is a safe and effective personalized cancer immunotherapy that can comprise naturally occurring ex vivo expanded cells (e.g., tumor-infiltrating lymphocytes [TIL]) or T cells genetically engineered to confer antigen specificity (T-cell receptor [TCR] or chimeric antigen receptor [CAR] eng...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-018-0779-3
更新日期:2019-02-01 00:00:00
abstract::The prevalence and incidence of adverse drug interactions involving nonsteroidal anti-inflammatory drugs (NSAIDs) remains unknown. To identify those proposed drug interactions of greatest clinical significance, it is appropriate to focus on interactions between commonly used and/or commonly coprescribed drugs, interac...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199308020-00002
更新日期:1993-02-01 00:00:00
abstract::Safe and effective treatment of major depression, one of the most common comorbid conditions in individuals infected with HIV, significantly lowers morbidity and mortality from HIV disease. However, optimal treatment of both conditions is complicated by interactions between the disease processes as well as the pharmac...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200528090-00002
更新日期:2005-01-01 00:00:00
abstract::The biologics have revolutionized the treatment of rheumatoid arthritis (RA). However, there are still patients that are difficult to control and a cure is still not achievable. Tofacitinib, a Janus kinase (JAK) inhibitor is an orally available, new-in-class, disease-modifying anti-rheumatic drug with similar efficacy...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-016-0430-0
更新日期:2016-09-01 00:00:00