Post-approval safety issues with innovative drugs: a European cohort study.

abstract：:Lipodystrophy complications, including lipoatrophy (pathological fat loss) and metabolic complications, have emerged as important long-term toxicities associated with antiretroviral therapy in the current era. The wealth of data that has accumulated over the past 6 years has now clarified the contribution of specific ...

journal_title：Drug safety

authors： Nolan D

更新日期：2005-01-01 00:00:00

abstract：BACKGROUND:Rituximab is a monoclonal antibody approved for treating CD20-positive B-cell non-Hodgkin's lymphoma and rheumatoid arthritis but is used off-label for treating many autoimmune disorders, including multiple sclerosis (MS). Similarly to other monoclonal antibodies, the incidence of infusion-related reactions ...

journal_title：Drug safety

authors： Brown BA,Torabi M

更新日期：2011-02-01 00:00:00

abstract：BACKGROUND:Over-the-counter analgesics (OTCAs), principally paracetamol (acetaminophen)-containing compounds and NSAIDs, are commonly used medications. Guidelines for the use of these agents in patients with chronic liver disease (CLD) are not available, despite the possibility that such patients may be more susceptibl...

journal_title：Drug safety

authors： Rossi S,Assis DN,Awsare M,Brunner M,Skole K,Rai J,Andrel J,Herrine SK,Reddy RK,Navarro VJ

更新日期：2008-01-01 00:00:00

abstract：:The risk of coronary events with non-steroidal anti-inflammatory drugs has been the subject of much debate since the original trial of rofecoxib raised the issue. Since then, over almost 20 years, such risks have been shown in clinical trials of long-term high-dose users, and in observational studies comparing users w...

journal_title：Drug safety

authors： Moore N

更新日期：2020-04-01 00:00:00

abstract：INTRODUCTION:Adverse event (AE) under-reporting has been a recurrent issue raised during health authorities Good Clinical Practices (GCP) inspections and audits. Moreover, safety under-reporting poses a risk to patient safety and data integrity. The current clinical Quality Assurance (QA) practices used to detect AE un...

journal_title：Drug safety

authors： Ménard T,Barmaz Y,Koneswarakantha B,Bowling R,Popko L

更新日期：2019-09-01 00:00:00

abstract：BACKGROUND:Acute liver failure is idiopathic and drug-related in, respectively, around 50 and 15 % of children. Population-based, epidemiologic data about the pattern of disease manifestation and incidence of less severe acute liver injury, either idiopathic or potentially drug-attributed are limited in children and ad...

journal_title：Drug safety

authors： Ferrajolo C,Verhamme KM,Trifirò G,'t Jong GW,Giaquinto C,Picelli G,Oteri A,de Bie S,Valkhoff VE,Schuemie MJ,Mazzaglia G,Cricelli C,Rossi F,Capuano A,Sturkenboom MC

更新日期：2013-10-01 00:00:00

abstract：BACKGROUND:Current pharmacosurveillance methods do not provide timely information on drug safety and effectiveness. Real-time surveillance using electronic prescribing systems could address this problem; however, the data collected using these systems has not been validated. We investigated the accuracy of using orders...

journal_title：Drug safety

authors： Eguale T,Tamblyn R,Winslade N,Buckeridge D

更新日期：2008-01-01 00:00:00

abstract：:Data on the efficacy and tolerability of antiretrovirals in children are limited as, in contrast to adult studies, large paediatric cohort studies are lacking. Thus, data pertaining to adults are often extrapolated to children despite the acknowledgement that children are not little adults. This review summarises info...

journal_title：Drug safety

authors： Lemberg DA,Palasanthiran P,Goode M,Ziegler JB

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

authors： Nordeng H,Spigset O

更新日期：2005-07-01 00:00:00

abstract：:Betahistine is a structural analogue of histamine that is prescribed for the treatment of vestibular disorders such as Ménière's disease and the symptomatic treatment of vertigo. It is estimated from sales information that >130 million patients have been exposed to the drug since its registration in 1968. In this revi...

journal_title：Drug safety

authors： Jeck-Thole S,Wagner W

更新日期：2006-01-01 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

authors： Hiltunen M,Lönnrot M,Hyöty H

更新日期：1999-03-01 00:00:00

abstract：:Impulse control disorders (ICDs) are a well-known adverse effect of dopamine agonists (DAAs). This critical review aims to summarize data on the prevalence and factors associated with the development of an ICD simultaneous to DAA use. A search of two electronic databases was completed from inception to July 2017. The ...

journal_title：Drug safety

authors： Grall-Bronnec M,Victorri-Vigneau C,Donnio Y,Leboucher J,Rousselet M,Thiabaud E,Zreika N,Derkinderen P,Challet-Bouju G

更新日期：2018-01-01 00:00:00

abstract：:Intranasal corticosteroids and intranasal antihistamines are efficacious topical therapies in the treatment of allergic rhinitis. This review addresses their relative roles in the management of this disease, focusing on their safety and tolerability profiles. The intranasal route of administration delivers drug direct...

journal_title：Drug safety

authors： Salib RJ,Howarth PH

更新日期：2003-01-01 00:00:00

abstract：INTRODUCTION:Non-steroidal anti-inflammatory drugs are associated with a dose and duration-dependent coronary risk. There is little information concerning analgesic-dose ibuprofen, among the most widely used drugs worldwide. OBJECTIVE:Our objective was to measure the risks of acute coronary syndrome (ACS) after dispen...

journal_title：Drug safety

authors： Duong M,Abouelfath A,Lassalle R,Droz C,Blin P,Moore N

更新日期：2018-11-01 00:00:00

abstract：:A spectrum of adverse drug reactions that are caused by the combined action of drugs and viruses has been described: ampicillin rash in acute infectious mononucleosis; Reye's syndrome; hypersensitivity reactions to sulphonamides in patients with HIV infection; drug-induced agranulocytosis; paracetamol (acetaminophen) ...

journal_title：Drug safety

authors： Levy M

更新日期：1997-01-01 00:00:00

abstract：:A number of affluent countries are moving to eliminate thiomersal (thimerosal), an ethylmercury preservative, from vaccines as a precautionary measure because of concerns about the potential adverse effects of mercury in infants. The WHO advocates continued use of thiomersal-containing vaccines in developing countries...

journal_title：Drug safety

authors： Bigham M,Copes R

更新日期：2005-01-01 00:00:00

abstract：:Women who discover they are pregnant after exposure to a drug and pregnant women who have a condition that requires continued treatment during pregnancy are told to balance the benefits and risks of the exposure to justify continuation of treatment, discontinuation of treatment or, possibly, pregnancy termination. How...

journal_title：Drug safety

authors： Shields KE,Wiholm BE,Hostelley LS,Striano LF,Arena SR,Sharrar RG

更新日期：2004-01-01 00:00:00

abstract：BACKGROUND:Atypical antipsychotics have been associated with metabolic abnormalities including impaired glucose metabolism, exacerbation of existing diabetes mellitus and new-onset type 2 diabetes. Not all atypical antipsychotic agents appear to have the same propensity to cause these complications. OBJECTIVE:To asses...

journal_title：Drug safety

authors： Ramaswamy K,Kozma CM,Nasrallah H

更新日期：2007-01-01 00:00:00

abstract：:There are 2 isoenzymes of cyclo-oxygenase (COX). There is a constitutive enzyme COX-1 which has a wide tissue distribution. In addition there is an inducible enzyme COX-2 which has a restricted tissue distribution. The inducible enzyme COX-2 is responsible for the generation of prostaglandins at sites of tissue inflam...

journal_title：Drug safety

authors： Richardson C,Emery P

更新日期：1996-10-01 00:00:00

abstract：BACKGROUND:Following reports of sudden death in patients taking medication to treat attention-deficit hyperactivity disorder (ADHD), this study aimed to identify cases of death in patients prescribed stimulants and atomoxetine and to determine any association between these and sudden death. METHOD:The UK General Pract...

journal_title：Drug safety

authors： McCarthy S,Cranswick N,Potts L,Taylor E,Wong IC

更新日期：2009-01-01 00:00:00

abstract：BACKGROUND:Case reports have related the use of HMG-CoA reductase inhibitors ('statins') to Parkinson's disease (PD). Paradoxically, however, statins may have potentially beneficial effects on neurodegenerative diseases due to their anti-inflammatory properties. OBJECTIVE:To explore the risk of the development of PD i...

journal_title：Drug safety

authors： Becker C,Jick SS,Meier CR

更新日期：2008-01-01 00:00:00

abstract：:Epidural analgesia for caesarean section is increasingly used and is gradually replacing general anaesthesia. Hypotension is one of the main risks: preloading of the maternal circulation is used to prevent maternal hypotension and its consequences. For this, various colloid and crystalloid solutions are used. We repor...

journal_title：Drug safety

authors： Barbier P,Jonville AP,Autret E,Coureau C

更新日期：1992-01-01 00:00:00

abstract：INTRODUCTION:Detecting signals of safety concerns associated with complementary medicines (CMs) relies on spontaneous reports submitted by health professionals and patients/consumers. Community pharmacists are well placed to identify and report suspected adverse drug reactions (ADRs) associated with CMs, but pharmacist...

journal_title：Drug safety

authors： Barnes J,Butler R

更新日期：2020-11-01 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

authors： Schumock GT,Lee TA,Joo MJ,Valuck RJ,Stayner LT,Gibbons RD

更新日期：2011-07-01 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

authors： Wolf B,Zimmermann S,Arber C,Irving M,Trueb L,Coukos G

更新日期：2019-02-01 00:00:00

abstract：:Thrombocytopenia has been reported as an adverse reaction of numerous drugs. Vancomycin is often overlooked as a culprit but has been associated with several cases of thrombocytopenia that were not well described in the literature. A literature search was conducted to find reports of thrombocytopenia induced by vancom...

journal_title：Drug safety

authors： Mohammadi M,Jahangard-Rafsanjani Z,Sarayani A,Hadjibabaei M,Taghizadeh-Ghehi M

更新日期：2017-01-01 00:00:00

abstract：:All national guidelines for the management of hypertension recommend angiotensin receptor blockers (ARBs) as an initial or add-on antihypertensive therapy. The eight available ARBs have variable clinical efficacy when used for control of hypertension. Additive blood pressure-lowering effects have been demonstrated whe...

journal_title：Drug safety

authors： Abraham HM,White CM,White WB

更新日期：2015-01-01 00:00:00

abstract：:Pelargonium (Pelargonium sidoides DC and P. reniforme Curtis) is reported to have immune modulating properties and antibacterial activity, and Pelargonium extracts have been used for the treatment of respiratory tract and gastrointestinal infections. Introduced in the early 1980s in Germany, Umckaloabo (ISO Arzneimitt...

journal_title：Drug safety

authors： de Boer HJ,Hagemann U,Bate J,Meyboom RH

更新日期：2007-01-01 00:00:00

abstract：:In general, the selective estrogen receptor modulators (SERMs) currently indicated for the treatment and prevention of breast cancer, i.e. tamoxifen and toremifene, are fairly well tolerated. However, tamoxifen has been shown to induce hepatocellular carcinomas in rats, but not in humans, and can increase the risk of ...

journal_title：Drug safety

authors： Curtis MG

更新日期：2001-01-01 00:00:00

abstract：:While classifications into generations according to antimicrobial activity has helped clinicians incorporate the increasing number of cephalosporins into their pharmacological repertoire, adverse effects among the different agents fail to follow similar categories. In general, cephalosporins are fairly well tolerated ...

journal_title：Drug safety

authors： Thompson JW,Jacobs RF

更新日期：1993-08-01 00:00:00