Expert opinion on drug safety
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Expert Opin Drug Saf · Jan 2006
ReviewCoagulopathy and the role of recombinant human activated protein C in sepsis and following polytrauma.
Recombinant human activated protein C (rhAPC) also known as drotrecogin alfa (activated) has known antithrombotic, anti-inflammatory, and profibrinolytic properties in severe sepsis. Treatment with rhAPC (Xigris) has been shown to reduce mortality in patients with severe sepsis. The lack of any trials of rhAPC in trauma patients means that a definitive recommendation regarding its use in the polytraumatised patient, in whom severe head trauma or other contraindications for the use of rhAPC have been excluded remains controversial at present. This article describes the current evidence of its efficacy and safety in severe sepsis with relation to surgery and trauma.
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Allergy to beta-lactam antibiotics is the most frequent cause of drug-induced immunological reactions, although the prevalence is not exactly known. IgE- and T-cell-dependent responses are the main mechanisms involved, although other immunological mechanisms can also participate, especially in haematological abnormalities, such as immune haemolytic anaemia or thrombocytopoenia. ⋯ Benzylpenicillin is no longer the beta-lactams most frequently prescribed and other chemical structures, with new or modified haptens, have progressively replaced it. This is relevant for the diagnostic evaluation and management of beta-lactam hypersensitivity.
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Expert Opin Drug Saf · Jan 2006
ReviewWhen science is not enough - a risk/benefit profile of thiomersal-containing vaccines.
Without a preservative, such as thiomersal (known as thimerosal in the US), multi-dose liquid presentations of vaccine are vulnerable to bacteriological contamination that can result in death or serious illness of the recipient. Concerns about levels of mercury exposure from thiomersal-containing vaccines were first raised in the US during 1999 in the context of Hepatitis B vaccine for newborns. Since then, a large body of evidence from animal and epidemiological studies has accumulated on the safety of thiomersal. ⋯ There is a real danger that this controversy may result in the loss to the world of thiomersal as a preservative, simply from popular pressure. In reality, it would be impossible to cease overnight using thiomersal and maintain the supply of vital vaccines. This paper reviews and summarises the data available from published studies on mercury toxicity, and thiomersal in vaccines in particular, that overwhelmingly indicate continued use of thiomersal is safe in those countries where it is most needed.