Gene/Protein Disease Symptom Drug Enzyme Compound
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The reported incidence of hypersensitivity reactions (HSRs) associated with oxaliplatin in patients with colorectal cancer (CRC) is approximately 12%, with 1 - 2% of patients developing grade 3 or 4 in severity. However, the recent rising incidence of HSR to oxaliplatin observed is the result of increasing clinical use. HSR to oxaliplatin may manifest as facial flushing, rash/hives, tachycardia, dyspnoea, erythema, pruritus, fever, tongue swelling, headache, chills, weakness, vomiting, burning sensations, dizziness and oedema. Anaphylactic shock is rare but serious, and must be considered in the event of hypotension. No definitive approaches to prevent and treat HSR associated with oxaliplatin are available; however, few successful strategies have been reported. Such strategies include: slowing the infusion rate, use of steroids and antagonists of type 1 and 2 histamine receptors, and desensitisation. Successful implementation of oxaliplatin desensitisation protocols based on other platinum-containing compounds have been reported, which could enable a small number of patients who experience severe HSR to further receive an effective therapy for CRC. However, reintroductions have only been reported as single case studies or small cohorts. Large-scale validation on desensitisation strategies are still missing. Recently, subcutaneous adrenaline has also been utilised as an alternative approach to manage HSR to oxaliplatin. Knowledge of this rare but real toxicity of oxaliplatin is paramount because the use of this drug continues to increase not only for the treatment of patients with stage II-IV CRC, but also other solid malignancies. In this article, the author discusses the incidence, clinical presentation, pathogenesis, risk factors and current strategies of management of HSR associated with oxaliplatin.
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PMID:Hypersensitivity reactions associated with oxaliplatin. 1690 58

Nabumetone is a nonsteroidal antiinflammatory (NSAID) prodrug that inhibits cyclooxygenase-2. It has been recommended as a safe alternative in most patients with hypersensitivity reactions to NSAIDs. Systemic reactions caused by nabumetone are not frequent. We report 2 cases of immediate systemic reactions due to nabumetone. The first case involved a 68-year-old woman who developed immediate generalized pruritus, erythema, morbilliform eruption, swollen tongue sensation, diarrhea, and hypotension after the ingestion of a single dose of nabumetone. In the second case, a 77-year-old woman developed generalized pruritus, palm erythema, colic abdominal pain, diarrhea, dizziness, tightness of the chest, dyspnea, and hypotension immediately after oral intake of nabumetone. Both patients had previously tolerated this drug. Since these episodes, they have avoided nabumetone. Skin prick tests with nabumetone (10 and 100 mg/mL) were negative. Oral challenge tests with other NSAIDs, even of the same group as nabumetone, were negative in both patients. The mechanisms responsible for the reaction were not established.
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PMID:Severe immediate reaction to nabumetone. 1769 3

Hypersensitivity reactions (HSR) to oxaliplatin in patients with colorectal cancer include facial flushing, erythema, pruritus, fever, tachycardia, dyspnea, tongue swelling, rash/hives, headache, chills, weakness, vomiting, burning sensations, dizziness, and edema. We report a patient with fever as the sole manifestation of initial HSR, review the literature and discuss the management of HSR. A 57-year-old female with T3N2M0 rectal adenocarcinoma received modified FOLFOX-6. She tolerated the first 8 cycles without any toxicities except grade 1 peripheral neuropathy and nausea. During 9th and 10th infusions, she developed fever to a maximum of 38.3 centigrade with stable hemodynamic status despite medications. During 11th infusion, she developed grade 3 HSR consisting of symptomatic bronchospasm, hypotension, nausea, vomiting, cough, and fever. On examination, she was pale, cyanotic, with a temperature of 38.8 centigrade, BP dropped to 95/43 mm Hg, pulse of 116/min and O(2) saturation of 88%-91%. She was hospitalized for management and recovered in 24 h. Fever alone is not a usual symptom of oxaliplatin HSR. It may be indicative that the patient may develop serious reactions subsequently, as did our patient who developed hypotension with the third challenge. Treatment and prevention consists of slowing the infusion rate, use of steroids and antagonists of Type 1 and 2 histamine receptor antagonists, whereas desensitization could help to provide the small number of patients who experience severe HSR with the ability to further receive an effective therapy for their colorectal cancer.
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PMID:Fever as the only manifestation of hypersensitivity reactions associated with oxaliplatin in a patient with colorectal cancer Oxaliplatin-induced hypersensitivity reaction. 1787 1

Although the reported incidence of hypersensitivity reactions (HSR) to antineoplastic agents is considered to be uncommon, it is difficult to evaluate their exact prevalence, mainly because their definition is vast and pathogenic mechanisms are vague. HSR include facial flushing, erythema, pruritus, fever, tachycardia, dyspnea, tongue swelling, rash/hives, headache, chills, weakness, vomiting, burning sensations, dizziness, and edema. Treatment and prevention consists of slowing the infusion rate, steroids, and type 1 and 2 histamine receptor antagonists. Desensitization could allow the small number of patients who experience severe HSR to receive effective therapy for their cancer. Reintroductions have only been reported as single case studies or small cohorts. Large-scale validation on desensitization strategies is still missing. With regard to oxaliplatin, knowledge of its rare but eminent toxicity is paramount, because this drug is widely used in treating colorectal cancer, the second-highest cause of cancer mortality in the United States.
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PMID:Hypersensitivity reactions to oxaliplatin and other antineoplastic agents. 1837 76

The ability of catfish to inflict extremely painful wounds with their pectoral and dorsal stings has been well known for many decades. The venom apparatus of the African catfish Clarias gariepinus (Burchell, 1822), and stinging catfish Heteropneustes fossilis (Bloch, 1794) is constituted by a single, sharp and stout sting immediately in front of the soft-rayed portion of the pectoral fins. The sting has well developed articulations, making it possible for it to become erect and locked. The toxicological centres in Poland have recorded 17 cases of envenomations caused by stinging catfish and African catfish; the injury was accompanied by intense pain, numbness of the site, dizziness, local oedema and erythema. In addition, systemic symptoms such as tachycardia, weakness and arterial hypotension were observed. The treatment of these injuries should include cleansing of the wound and surrounding area. Immersion of the wounded extremity in hot water (45 degrees C) was used for the pain control. An attempt to remove any spinal sheath or remnant must be undertaken. Antibiotic management depends on several factors: the age and immune status of the victim, the interval between injury and presentation, or the presence of a foreign body. The most serious long-term complications of sting envenomation involve infections.
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PMID:Catfish stings and the venom apparatus of the African catfish Clarias gariepinus (Burchell, 1822), and stinging catfish Heteropneustes fossilis (Bloch, 1794). 1858 96

Trichloroethane functions in cosmetics as a solvent. Although Trichloroethane has been reported to the Food and Drug Administration (FDA) to be used in cosmetic products, an industry survey found that it is not in current use in the cosmetic industry. Trichloroethane is considered a Class I ozone-depleting substance by the Environmental Protection Agency (EPA) and its use is prohibited in the United States, unless considered essential. The FDA has stated that Trichloroethane's use in cosmetics is considered nonessential. Trichloroethane is detected by gas chromatography, gas chromatography-mass spectrometry, and gas-liquid chromatography. In rats, Trichloroethane, whether inhaled or injected, is mostly expelled intact from the body through exhalation. A very small percentage is excreted in the urine. In humans, Trichloroethane is rapidly absorbed through the skin and eliminated in exhaled air and a very small percentage is excreted in urine. Inhaled Trichloroethane is eliminated in exhaled air. Acute oral LD(50) values have been reported as follows: 12.3 g/kg in male rats; 10.3 g/kg in female rats; 11.24 g/kg in female mice; 5.66 g/kg in female rabbits; and 9.47 g/kg in male guinea pigs. Acute toxicity studies using other routes of exposure, including subcutaneous injection and inhalation, produced no evidence of significant toxicity, except at very high exposure levels. Continuous inhalation exposure of rabbits to 750 mg/m(3) for 90 days did not produce any signs of toxicity. Continuous exposure of rats, guinea pigs, rabbits, and monkeys to 500 ppm Trichloroethane for 6 months did not produce any signs of toxicity. Other short-term and subchronic inhalation exposures confirmed acute and short-term exposure findings that the toxic effects of inhalation were a function of both concentration and time. Rats receiving 750 or 1500 mg/kg day(- 1) Trichloroethane in corn oil by oral gavage 5 days per week for 78 weeks had reduced body weights and early mortality. Reduced body weights, decreased survival rates, and early mortality (in females) were found in mice dosed with 3000 or 6000 mg/kg day(- 1) (over the last 58 weeks; lower doses were administered for the first 20 weeks). Mice exposed to prolonged periods of Trichloroethane in an inhalation chamber had increased motor activity at levels up to 5000 ppm. Further increase of concentration of exposure resulted in less of an increase of motor activity until motor activity began to fall below normal at 10,000 ppm. Adverse effects on motor activity in rats were seen at exposures as low as 3000 ppm for 4 h. Rabbits had slight reddening and scaling after 10 24-h applications to abdominal skin of Trichloroethane mixed with 2.4% to 3.0% dioxane, and slight to moderate erythema, slight edema, and slight exfoliation was observed when 75% Trichloroethane and 25% tetrachloroethylene were applied to rabbit ears for 11 days. Undiluted Trichloroethane applied to the clipped backs of guinea pigs produced histopathologic damage in the epidermis. A primary irritation index of 5.22 (out of 8) was reported in rabbits. Trichloroethane applied to the eyes of rabbits resulted in transient irritation and apparent pain, but no corneal damage. There was no effect on gestation, pup survival, or growth in mice given Trichloroethane in drinking water at up to 5.83 mg/ml during mating and/or gestation. Rats exhibited no or minimal effects of ingestion of Trichloroethane up to 30 ppm in drinking water during mating and/or gestation. There was no effect on gestation, pup survival, or growth in mice or rats inhaling 875 ppm Trichloroethane. However, prenatal exposure of rodents to Trichloroethane can produce developmental toxicity in the form of delayed development in the offspring. Trichloroethane has been found to be mutagenic in the Ames assay in some studies and not mutagenic in others. Trichloroethane induced transformations in Fischer rat embryo cell system at 99 mu M, was not mutagenic using the mouse lymphoma assay at up to 0.51 mu g/ml, was equivocal in that assay when tested with S9, and was also equivocal in a sister-chromatid exchange assay using Chinese hamster ovarian (CHO) cells with and without S9. Mice ingesting 80,000 ppm Trichloroethane in their drinking water had an increase in the frequency of micronucleated normochromatic erythrocytes. A peripheral blood micronucleus test in female mice was negative. Trichloroethane was not carcinogenic to rats when administered 1500 mg/kg by oral gavage 5 days/week for 78 weeks or in mice administered 6000 mg/kg. Exposure to 1500 ppm Trichloroethane vapor for 6 h/day, 5 days/week for 2 years likewise gave no indications of oncogenic effects in rats or mice. People who have been exposed to Trichloroethane have reported dizziness, lassitude, unconsciousness, respiratory depression, peripheral vascular collapse, impaired postural control, mild encephalopathy, perioral tingling, burning on the tongue and discomfort in the hands and feet. The Cosmetic Ingredient Review (CIR) Expert Panel recognizes that Trichloroethane (1,1,1-Trichloroethane) has been declared a Class I ozone-depleting substance by the EPA and its use is limited to essential products. The FDA has determined that use of Trichloroethane in aerosol cosmetic products is considered nonessential. At issue for this assessment is the safety of direct exposure to individuals as a result of exposure to cosmetic products that may contain Trichloroethane. The Expert Panel found the available data to be sufficient to support the safety of Trichloroethane as a solvent in cosmetic products.
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PMID:Final report on the safety assessment of Trichloroethane. 1910 34

Trichloroethylene-induced hypersensitivity dermatitis is one of the serious occupational health events in China, however, little is known about the clinical features and possible mechanism of this disorder. The objective of the present study was to report some typical trichloroethylene-induced dermatitis patients and investigate their occupational exposure as well as the clinical features. We sampled and tested some cleaning agents from the companies where TCE-induced skin disorder occurred, the trichloroethylene concentrations were also monitored in the workplace air. Additionally, the symptoms, signs and laboratory test results of patients were collected. TCE concentrations varied from 10.2% to 91.4% in the cleaning agent by gas chromatography-mass chromatography analysis, and TCE levels in the workplace air ranged between 18 mg/m(3) and 683 mg/m(3), at most sampled sites TCE levels were higher than China national health standard for TCE. The trichloroethylene exposure time of the patients was 5-90 days (average 38.2 d), the patients with headache, dizziness, skin itch, fever were 90.5%, 100%, 100%, and 61.9%, respectively. 85.7% patients had skin erythema, 90.5% with rashes, and 38.1% with blisters. In addition, liver enlargement occurred in 3 patients, the abnormal rate of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (T-Bil) were 90.5%, 85.7% and 76.2%, respectively. 6 out of 15 patients were with abnormal electrocardiogram, and trichloroacetic acid (TCA) elevated in 14 patients (66.7%). Taken together, the major detrimental effect of trichloroethylene was to induce hypersensitivity dermatitis and liver dysfunction, the occurrence of this disorder is likely related to the individual hypersensitivity to trichloroethylene exposure.
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PMID:Severe hypersensitivity dermatitis and liver dysfunction induced by occupational exposure to trichloroethylene. 1936 38

The stinging catfish Heteropneustes fossilis (Bloch, 1794) has become a popular aquarium fish in Poland and is available in almost every pet shop. The toxicological centers in Cracow, Gdansk and Warsaw have recorded twelve cases of envenomations caused by stinging catfish in the years 1994-2008. In most cases the injury was accompanied by oedema, erythema, intense pain, numbness of the site and dizziness. Schema of medical management was prepared using analysis of cases.
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PMID:[Stinging catfish spine envenamation]. 1978 29

BACKGROUND: Fentanyl buccal tablet (FBT; FENTORA(R), Cephalon, Inc., Frazer, PA, USA) is indicated in the US for breakthrough pain in patients with cancer who are already receiving and are tolerant to around-the-clock opioid therapy for underlying persistent cancer pain. For each individual patient, FBT should be titrated to the effective dose. OBJECTIVE: The primary objective was to characterize the pharmacokinetic parameters of FBT 400 microg administered as a single 400 microg tablet (regimen A) or as two 200 microg tablets given simultaneously (regimen B) and determine whether these are bioequivalent in healthy Japanese volunteers. Regimen C (two 200 microg tablets 30 minutes apart) was also compared as a secondary objective. METHODS: Healthy Japanese adults received regimens A, B, and C in a crossover fashion. Naltrexone was given to minimize the opioid effects of fentanyl. Serum fentanyl concentrations were determined in venous blood collected through 36 hours post dose. Regimens were declared bioequivalent with respect to bioavailability (as reflected by AUC(0-infinity), AUC(0-last), and C(max)) if the 90% confidence interval (CI) of the regimens' ratio fell within 0.80-1.25 (80%-125%). RESULTS: Twenty-nine volunteers (13 men, 16 women) were enrolled; 24 completed the study. Regimens A and B had bioequivalent systemic exposure parameters (B/A [90% CI]: AUC(0-infinity)108.4 [103.4, 113.7], AUC(0-last) 106.1 [100.7, 111.7], and C(max) 92.3 [83.2, 102.4]). Regimen C was bioequivalent to both A and B for AUCs, but only to B for C(max). Median time to C(max) was 45 minutes for regimen A and 60 minutes for regimens B and C. The most frequent AEs were dizziness, application-site erythema, headache, somnolence, nausea, and vomiting. All AEs were mild or moderate. CONCLUSIONS: Bioavailability of fentanyl after FBT 400 microg administered as a single tablet was bioequivalent to that after 2 simultaneously administered 200 microg tablets in healthy Japanese volunteers. AEs were mild or moderate.
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PMID:Relative Bioavailability of Fentanyl Following Various Dosing Regimens of Fentanyl Buccal Tablet in Healthy Japanese Volunteers. 1991 9

Ferumoxytol is an intravenous iron preparation for treatment of the anemia of chronic kidney disease (CKD). It is a carbohydrate-coated, superparamagnetic iron oxide nanoparticle. Because little free iron is present in the preparation, doses of 510 mg have been administered safely in as little as 17 seconds. Two prospective, randomized studies compared two doses of ferumoxytol 510 mg given in 5 +/- 3 days with 3 weeks of oral iron 200 mg/day (as ferrous fumarate) in anemic patients with CKD. One study enrolled 304 patients with stages 1-5 CKD (predialysis), and the other study enrolled 230 patients with stage 5D CKD (undergoing hemodialysis). In both studies, a greater increase in hemoglobin level from baseline to end of study (day 35) was noted in patients who received ferumoxytol compared with those who received oral iron (mean +/- SD 0.82 +/- 1.24 vs 0.16 +/- 1.02 g/dl in patients with stages 1-5 CKD and 1.02 +/- 1.13 vs 0.46 +/- 1.06 g/dl in patients with stage 5D CKD, p<0.001). A greater proportion of both predialysis and hemodialysis patients who received ferumoxytol had hemoglobin level increases from baseline of 1 g/dl or more compared with those who received oral iron (p<0.001). In a prospective, double-blind, crossover study of more than 700 patients with CKD stages 1-5D that compared the safety of ferumoxytol with normal saline injection, the rates of treatment-related adverse events were 5.2% and 4.5%, respectively. Serious treatment-related adverse events were seen in one patient in each treatment group. The most common adverse events with ferumoxytol occurred at the injection site (bruising, pain, swelling, erythema). Dizziness, nausea, pruritus, headache, and fatigue occurred in less than 2% of patients receiving ferumoxytol, with a similar frequency noted after administration of normal saline. In short-term studies, intravenous ferumoxytol was safely and rapidly administered, and was more effective than oral iron therapy in increasing hemoglobin levels in anemic patients with CKD. Long-term clinical trials with clinical outcomes and studies comparing ferumoxytol with other parenteral iron agents will help define the role of ferumoxytol in treating the anemia of CKD.
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PMID:Ferumoxytol: a new intravenous iron preparation for the treatment of iron deficiency anemia in patients with chronic kidney disease. 2003 Apr 75


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