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Vaccine safety controversies and the future of vaccination programs.

In the years following the hepatitis B vaccination/multiple sclerosis controversy, a number of new issues regarding vaccine safety have been raised, in some cases leading to more debate and confusion. Against this background, an international group of experts was convened to review the current points of view concerning the use of thimerosal as a preservative and its potential risks; the suggested link between thimerosal-containing vaccines and acute lymphoblastic leukemia; the alleged association between aluminum-containing vaccines/macrophagic myofasciitis and general systemic complaints; a p…

Tissue safety in view of CJD and variant CJD.

Epidemiological studies on human transmissible spongiform encephalopathies (Creutzfeldt-Jakob Disease, CJD) have shown that the agent could be transmitted by highly infectious tissues like brain, spinal cord or retina and medicinal products derived from these tissues (i.e. human growth hormone, dura mater). A few cases of transmission of CJD by neurosurgical instruments have been reported. The transmission of the agent of variant CJD, which is suspected to be transmitted by BSE-contaminated food, by blood transfusion implies that in contrast to the agent of classical CJD this agent can also be

Oxcarbazepine: Efficacy, safety, and tolerability in the treatment of mania.

A twelve-week study examined the efficacy, safety, and tolerability of oxcarbazepine in the treatment of mania. Twenty male subjects, all of whom were stable on valproic acid, qualified for the study. The conversion from valproic acid to oxcarbazepine was completed over a three-week period. Scores from the BPRS, CGI and SAJEE-GI were collected and analyzed. The results of the study supported the efficacy, safety, and tolerability of oxcarbazepine for the treatment of mania. Another potential advantage of oxcarbazepine is a metabolic pathway that may reduce drug interactions. Qnt] Psych Can Pra…

Safety of growth hormone replacement therapy in adults.

Growth hormone (GH) is a powerful metabolic hormone that regulates fuel homeostasis through its protein anabolic and lipolytic actions. The introduction of recombinant human GH has expanded the narrow indication of treating children with severe GH deficiency (GHD) to include a broader target population of children with growth retardation and short stature and adults with hypopituitarism and severe GHD. Furthermore, because children continue to receive GH replacement therapy into adult life, the duration of treatment exposure has increased and the safety of long-term GH treatment has become inc…

Tolerability and safety of HIV protease inhibitors in adults.

Antiretroviral drugs are associated with both short-term and long-term adverse events. Like other HIV drugs, protease inhibitors (PIs) may a … ion of PIs as a class should be reconsidered and that it is probably not appropriate to extrapolate safety data obtained from individuals treated with first-generation agents in the era of potent combination antiretroviral therapy to those treated with recently developed PIs. Because PIs remain a critical component of successful antiretroviral therapy, e …

Relative safety and efficacy of finasteride for treatment of hirsutism.

OBJECTIVE: To evaluate the relative safety and efficacy of finasteride for treatment of hirsutism related to hyperandrogenism in women. DATA SOURCES: Literature retrieval was accessed through MEDLINE (1966-March 2003) using the terms finasteride and hirsutism. Additional information was obtained from the drug manufacturer. DATA SYNTHESIS: Finasteride has been evaluated for treatment of hirsutism in multiple observational and randomized trials. Finasteride lowered hirsutism scores by 30-60% in most trials, as well as decreasing average hair diameter. In comparative trials, finasteride demonst…

Efficacy and safety of ivermectin and thiabendazole in the treatment of strongyloidiasis.

Treatment of strongyloidiasis has been traditionally based on thiabendazole, despite its frequent gastrointestinal side effects and failure to achieve eradication of the parasite from faeces in approximately 30% of cases. Ivermectin has been shown to be more effective for treating chronic uncomplicated strongyloidiasis. The efficacy and tolerability of these drugs in a series of patients treated from 1999 to 2002 at the Oliva Health Centre, Valencia, Spain, are reported. A total of 88 patients diagnosed of strongyloidiasis were treated using the following regimens: thiabendazole 25 mg/kg/12 h

The safety and tolerability of donepezil in patients with Alzheimer's disease.

Cholinesterase (ChE) inhibitors, which prevent the hydrolysis of acetylcholine, have been approved for the symptomatic treatment of Alzheime … nt use and an extensive publication database demonstrate that donepezil has a good tolerability and safety profile.

Safety and effectiveness of large-volume enema solutions.

The effectiveness and side effects of three types of enema solutions were compared in healthy subjects. Using a repeated-measures, double-blind design, the three different enemas (soapsuds, tap water, and polyethylene glycol-electrolyte solution) were given at 1-week intervals to 24 healthy volunteers. Soapsuds and tap water enemas produced significantly greater returns than polyethylene glycol electrolyte solution (PEG-ES) and were also more uncomfortable. Rectal biopsies showed surface epithelium loss after soapsuds and tap water but not after PEG-ES enemas. Before recommending changes in nu

Antipyretic efficacy and safety of ibuprofen and acetaminophen in children.

OBJECTIVE: To evaluate the antipyretic effects and safety of ibuprofen compared with acetaminophen in febrile children. DATA SOURCES: Searches of MEDLINE (1966-November 2003) and EMBASE (1988-November 2003) were conducted using the terms ibuprofen and acetaminophen. Bibliographies of selected articles were reviewed. DATA SYNTHESIS: Ibuprofen was significantly more effective than acetaminophen in reducing fever after a single dose. Ibuprofen was found to be more effective after 6 hours, but not after a longer period of time. Studies with multiple doses have also failed to show that one drug i…

Gastrointestinal safety of paracetamol: is there any cause for concern?

Paracetamol is classically considered as a very safe analgesic/antipyretic compound and, more specifically, as being virtually devoid of any gastrointestinal (GI) ulcerogenic potential. Accordingly, it is widely stated that paracetamol is particularly suitable for patients at high risk of developing GI ulcers or bleeds. This view has been challenged by recent epidemiological studies using computerised prescription data, which indicated that paracetamol exhibits dose-dependent GI toxicity. However, the results of these studies are most likely incorrect for reasons of inherent biases and confoun

Safety and efficacy of growth hormone therapy in childhood.

Growth hormone (GH) has been used for more than 40 years. GH improves height velocity in many conditions associated with impaired growth and corrects metabolic deficits attributable to GH deficiency (GHD). Many studies and surveillance programs exist to collect efficacy and safety data. GH has been demonstrated to have a relatively wide safety margin. Reported side effects, including pseudotumor cerebri, edema, slipped capital femoral epiphysis (SCFE), worsening of scoliosis, gynecomastia, and hyperglycemia require careful monitoring. Currently, there are no data suggesting that GH therapy inc…

Safety of a new oral contraceptive containing drospirenone.

New chemical entities must undergo rigorous, and preferably independent, safety and efficacy assessments before entry into the market. This is also true for oral contraceptives (OCs) given their extensive usage by healthy women and the safety concerns highlighted by the so-called 'third generation pill scare' in Europe a decade ago. This scare heightened patient and physician awareness of the increased risk of thromboembolic complications (mainly venous thromboembolism [VTE]) associated with OC use. Yasmin (ethinylestradiol 30 microg/drospirenone 3 mg [EE/DRSP]) is a novel OC that was demonstr…

Measles, mumps and rubella--safety of the combined vaccine.

Despite the fact that scientific evidence shows no support for a link between the combined measles, mumps and rubella vaccine (MMR) and autism or bowel problems, many parents remain worried. This article discusses the reasons for the introduction of MMR and outlines the debate about its safety and the problems associated with using single vaccines.

Текущая безопасность кровопотока в США.

Как и другие развитые страны, Соединенные Штаты уделяют большое внимание безопасности крови. Благодаря тщательному отбору доноров и использованию передовых тестов, включая анализ нуклеиновой кислоты (NAT), риск передачи вируса иммунодефицита человека и вируса гепатита С был сокращен до примерно 1 к 1,5 миллионам пожертвований. NAT для вируса гепатита В не был введен, но, тем не менее, риск невелик. В последнее время особое внимание уделяется новым инфекциям. NAT для вируса Западного Нила была внедрена в течение 6-8 месяцев с момента признания необходимости предотвращения переливания этого неда

Совпадение в аннотации оригинала
In common with other developed countries, the United States has placed a great deal of emphasis on blood safety. As a result of careful donor selection and the use of advanced tests, including nucleic acid testing (NAT), the risk of transmission of human immunodeficiency virus and hepatitis C virus has been reduced to about 1 in 1.5 million donations. NAT fo…

Safety in road crossing of children with cerebral palsy.

AIM: Children with cerebral palsy (CP) are regularly confronted with physical constraints during locomotion. Because abnormalities in motor control are often related to perceptual deficits, the aim of this study was to find out whether children with CP were able to walk across a road as safely as their non-handicapped peers. METHOD: Ten children with CP and 10 non-handicapped children aged 4-14 y were asked to cross a simulated road if they felt the situation was safe. RESULTS: With respect to safety and accuracy of crossings, the behaviour of children with CP was comparable with that of non…

[Effectiveness and safety of adenosine in the therapy and diagnosis of arrhythmias].

Adenosine is a drug with unique clinical and electrophysiological properties. Despite this, its use in Slovakia is rare. The decisive reason, besides its price, is the physicians fear of potential adverse effects and their limited knowledge regarding its clinical use. This study was aimed at analysis of the contribution of adenosine to the treatment and diagnostics of arrhythmias and evaluation of its safety. We studied the effect of adenosine in 62 patients. Adenosine terminated paroxysmal supraventricular tachycardia (PSVT) in 16 of 44 patients (36.4%) and in another 21 patients (47.7%) we r…

The antiparasitic moxidectin: safety, tolerability, and pharmacokinetics in humans.

A study in healthy male volunteers was completed to evaluate the safety, tolerability, and pharmacokinetics of a single oral dose of the antiparasitic moxidectin (MOX). This drug is registered worldwide as a veterinary antiparasitic agent for use in companion and farm animals. This is the first study of MOX in humans. All subjects were between the ages of 18 and 45 years, with normal cardiac, hematologic, hepatic, and renal function. Doses of MOX studied were 3, 9, 18, and 36 mg in cohorts of 6 subjects each (5:1, MOX:placebo). At the 9-mg and 36-mg doses, two separate cohorts were completed, …

Barriers to sun safety in a Canadian outpatient population.

BACKGROUND: It has long been recognized that compliance with recommended sun safety practices is suboptimal, yet few investigations have explored the barriers that people face in practicing good sun safety. In this context, barriers can exist at the following three levels: knowledge of sun safety, acquisition of sun safety information, and implementation of specific sun protective measures. OBJECTIVE: The investigation reported herein sought to elucidate barriers to sun safety that individuals face. Ultimately, this study aimed to qualify the possible barriers that lead to a misalignment of c…

The efficacy and safety of olanzapine for the treatment of geriatric psychosis.

Elderly psychiatric patients often present with psychotic symptoms that need antipsychotic treatment. Olanzapine is one of the atypical antipsychotics with efficacy for psychotic symptoms and a safer side-effect profile than typical antipsychotics. This study was conducted to assess the efficacy and safety of olanzapine for treatment of geriatric psychosis. The sample population comprised 94 acute-ward patients who were 65 years of age or older. Clinical assessment was conducted at baseline and also at 4 weeks after commencement of olanzapine treatment, with use of the Brief Psychiatric Rating…