Blood products adverse effects

Incorporation of downstream processing steps known to inactivate a wide variety of viral types provides further assurance that the final product is unlikely to harbour active virus. Heating and irradiation are amongst the two most popular such approaches. Heating the product to between 40 and 60°C for several hours inactivates a broad range of viruses. Many biopharmaceuticals can be heated to such temperatures without being denatured themselves. Such an approach has been used extensively to inactivate blood-borne viruses in blood products. Exposure of product to controlled levels of UV radiation can also be quite effective, while having no adverse effect on the product itself. 

Two of the more interesting uses of pharmacokinetic data in risk assessment involve the neurotoxic agents lead and methylmercury (Chapter 4). In the case of lead, epidemiological studies have typically involved the development of quantitative relationships between levels of lead in the blood and adverse health effects. Other measures of lead in the body have also been used. Levels in blood are now very easy to measure, and they do carry the strong advantage that they integrate cumulative exposures from many possible sources (water, food, paint, soil, air, consumer products). Current public health targets for lead are expressed as blood concentrations, typically in pg/dL (Chapter 4). 

Myelosuppression is the most common serious adverse effect of ganciclovir treatment therefore, patients blood counts should be closely monitored. Neutropenia and anemia have been reported in 25 to 30% of patients, and thrombocytopenia has been seen in 5 to 10%. Elevated serum creatinine may occur following ganciclovir treatment, and dosage adjustment is required for patients with renal impairment. In animal studies, ganciclovir causes decreased sperm production, teratogenesis, and tumor formation. 

Other medications, which will not be discussed in the following chapters, have psychotropic actions that are considered to be side effects or adverse effects. Thus, some antihistamines (Le. products used to counteract allergic reactions) induce fatigue and drowsiness, and the same applies to some myorelaxants. Older antihypertensives (Le. agents reducing blood pressure) such as alpha-methyldopa (Aldomet ) or clonidine (Catapres 1) can cause fatigue and depression. 

Human plasma has a colloid osmotic pressure of 3.6 kPa, of which 2.8 kPa is contributed by albumin. Volume-for-volume, 4.5% albumin is approximately four times more effective in expanding the plasma volume than crystalloid solutions, and the effect lasts 6-8 hours, compared to only 15-20 min with crystalloids. Although popular in the past as volume expanders, albumin solutions have fallen into disfavour. They are prepared from pooled human plasma, with all the inherent risks of pooled blood products. Albumin can cause adverse reactions, similar to other transfusion reactions, such as chills, urticaria, and vasodilatation. These may be caused by organic or inorganic substances formed during the processing... 

Barbiturates reduce hepatic blood flow and glomerular filtration rate, but these drugs produce no adverse effects on hepatic or renal function. Barbiturates can exacerbate acute intermittent porphyria by inducing the production of hepatic ct -aminolevulinic acid (ALA) synthase (see Chapter 22). On rare occasions, thiopental has precipitated porphyric crisis when used as an induction agent in susceptible patients. 

Exposure to allylamine in industries synthesizing pharmaceuticals and other commercial products is a known occurrence. Allylamines are known to cause adverse effects, especially to the liver, kidney, heart and/or blood vascular systems in experimental humans. It has been reported that exposure to methyl-, ethyl-, heptyl-, and allylamines results in severe pathologic lesions of the above-mentioned vital organs in animals and humans.72 High doses of allylamines are always associated with the induction of fatal cardiovascular injury.72,73... 

Nitroprusside [nye troe PRUSS ide] is administered intravenously, and causes prompt vasodilation, with reflex tachycardia. It is capable of reducing blood pressure in all patients, regardless of the cause of hypertension. The drug has little effect outside the vascular system, acting equally on arterial and venous smooth muscle. [Note Because nitroprusside also acts on the veins, it can reduce cardiac preload.] Nitroprusside is metabolized rapidly (t1/2 of minutes) and requires continuous infusion to maintain its hypotensive action. Sodium nitroprusside exerts few adverse effects except for those of hypotension caused by overdose. Nitroprusside metabolism results in cyanide ion production, although cyanide toxicity is rare and can be effectively treated with an infusion of sodium thiosulfate to produce thiocyanate, which is less toxic and is eliminated by the kidneys (Figure 19.14). [Note Nitroprusside is poisonous if given orally because of its hydrolysis to cyanide.]... 

Pharmacokinetic data were collected as well as pharmacodynamic measurements of platelet aggregation support (ristocetin cofactor activity) and cuticle wound blood flow. An important component of these studies was the suitability of the model. These models were chosen because of the biochemical deficiency of the particular factors and the parallel clinical syndromes. Such in vivo data can help in determining activity and dosing when such a product is first used in human trials. The Refacto molecule was also studied in rats and monkeys to determine its no observed adverse effect level, that was more than 10 times normal circulating levels. The major toxicity observed was the development of antibodies to the molecule that blocked activity and resulted in an acquired hemophilia syndrome. Similar findings were demonstrated when plasma-derived material was injected into monkeys [20]. 

HNIG may interfere with immunisations, either recent or those scheduled in the next few weeks. Before administration of HNIG, patient history should be checked for adverse reactions to other blood products and excipients. Any side-effects should be reported immediately to your doctor. Side-effects include chills, fever, malaise and rarely anaphylaxis. 

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