Restricted drug distribution programs.
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Drug Industry↗
Biomedical subjects
Michael P Gabay
Publications and source records attributed to Michael P Gabay.
Galactogogues: medications that induce lactation.
Galactogogues are medications that aid in initiating and maintaining adequate milk production. Most exert their pharmacologic effects through interactions with dopamine receptors, resulting in increased prolactin levels and thereby augmenting milk supply. Metoclopramide remains the galactogogue of choice due to its documented record of efficacy and safety in women and infants. Domperidone crosses the blood brain barrier and into the breast milk to a lesser extent than metoclopramide, decreasing the risk of toxicity to both mother and infant possibly making it an attractive alternative. Traditional antipsychotics, sulpiride and chlorpromazine, have been evaluated, but adverse events limit their use. Human growth hormone, thyrotrophin-releasing hormone, and oxytocin have also been studied. Finally, a natural product, fenugreek, has been purported to be effective in anecdotal reports. Use of this agent may be warranted after considering risks versus benefits.
Adult↗
Continuous infusion of coagulation factor products.
OBJECTIVE: To review clinical information related to the use of continuous infusion factor products in patients with hemophilia. Specifically, case reports and open-label trials are summarized involving the use of factor VIII and recombinant factor VIIa for a variety of indications including surgical prophylaxis, acute bleeding, primary prevention, and management of inhibitors. In addition, issues surrounding the use of continuous infusion of factor products such as pharmacokinetic rationale, stability/sterility, and cost are reviewed. DATA SOURCES: Primary and review articles were identified through a MEDLINE search (1990-June 2001) and through secondary sources. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated, and all information deemed relevant was included in this review. DATA SYNTHESIS: Data concerning the administration of factor products are primarily detailed in open-label trials and case reports. Comparisons between intermittent bolus injections and continuous infusion of factor products are limited and primarily compare continuous infusion regimens with historical controls. The rationale behind the continuous-infusion approach is linked to the pharmacokinetics of factor products administered via this route. Pharmacokinetic data reveal that, with continuous infusion of factor products, a reduction in clearance and a maintenance of factor serum concentrations are noted. CONCLUSIONS: Administration of factor products (factor VIII and recombinant factor VIIa) via continuous infusion has produced favorable hemostatic effects compared with intermittent bolus injections. The advantages of continuous infusion include maintenance of a constant factor concentration, thereby reducing risk of bleeding from excessively low trough concentrations, and a decrease in factor consumption related to a reduction in factor clearance with constant infusion. Manufacturers recommend using reconstituted factor products either immediately or within 1-3 hours after reconstitution; however, several studies have found the products to be stable and sterile for longer periods.
Blood Coagulation Factors↗
Role of antibiotics for the prevention of cardiovascular disease.
OBJECTIVE: To evaluate the data regarding the use of antibiotic therapy for the prevention of cardiovascular events. DATA SOURCES: Pertinent literature was identified through a MEDLINE search (1966-September 2001) and through other secondary literature databases and/or bibliographies of pertinent articles. DATA SYNTHESIS: Cardiovascular disease is a common cause of morbidity and mortality among the general population, with well-defined risk factors (e.g., diabetes, hypertension, hyperlipidemia, cigarette smoking, genetic predisposition). Clinical data evaluating the association between the aforementioned risk factors and the development of atherosclerosis and subsequent cardiovascular disease are substantial; however, these risk factors may only partially explain the high prevalence of cardiovascular disease. The presence of Chlamydia pneumoniae within atherosclerotic lesions has been documented and may be an additional risk factor for the development and progression of cardiovascular disease. CONCLUSIONS: The results of primary and secondary prevention trials have shown conflicting evidence with regard to the beneficial effects of antibiotic therapy to reduce cardiovascular events. Currently, the lack of certainty in published data does not support the use of antibiotics for the prevention of cardiovascular disease. Clinicians should continue to emphasize interventions proven to reduce adverse cardiovascular events such as smoking cessation, reduction of hyperlipidemia, and control of hypertension.
Anti-Bacterial Agents↗
Association between honey consumption and infant botulism.
Infant botulism, a disease that results in a blockade of voluntary motor and autonomic functions, was first recognized in the United States in the late 1970s. Since then, more than 1000 cases in this country have been reported to the Centers for Disease Control and Prevention (CDC). Numerous studies have shown that the ingestion of honey is linked with infant botulism. In addition, honey samples across the United States have tested positive for Clostridium botulinum spores and toxins. Such substantial evidence led the CDC to recommend that honey not be given to infants younger than 12 months old. It is important that clinicians be familiar with this risk and should not recommend honey-containing products or supplements or the use of honey as a flavoring agent for infants in this age group.
Botulism↗