Patient safety hypersensitivity

The opioids generally have a high level of safety when used in therapeutic dosages. However, there are several notable exceptions. Morphine and other opioids are contraindicated in patients with hypersensitivity reactions to the opioids. In addition, morphine should not be used in patients with acute bronchial asthma and should... 

This drug is contraindicated in patients with known hypersensitivity to die drug and during die first trimester of pregnancy (Category B). This drug is used cautiously in patients widi blood dyscrasias, seizure disorders, and hepatic dysfunction. Safety in children (odier dian orally for amebiasis) lias not been established. 

FIGURE 69-3. Treatment algorithm3 for acute bacterial rhinosinusitis in patients with mild disease without recent antibiotic exposure.31 aAntibiotics are listed in order of predicted efficacy based on predicted clinical and bacteriologic efficacy rates, clinical studies, safety, and tolerability. Doses can be found in Table 69-4. 6Cephalosporins should be considered for patients with non-type I hypersensitivity to penicillins they are more likely to be effective than the alternative agents. cHigh doses (90 mg/kg per day) are recommended for most children, especially those with day-care contacts or frequent infections. 

Blood counts and liver function studies should be monitored during long-term therapy. The drug should not be given to patients with known hypersensitivity to other benzimidazole drugs or to those with cirrhosis. The safety of albendazole in pregnancy and in children younger than 2 years of age has not been established. 

Plasma levels of doxepin similar to those achieved during oral therapy may be obtained with topical application the usual drug interactions associated with tricyclic antidepressants may occur. Therefore, monoamine oxidase inhibitors must be discontinued at least 2 weeks prior to the initiation of doxepin cream. Topical application of the cream should be performed four times daily for up to 8 days of therapy. The safety and efficacy of chronic dosing has not been established. Adverse local effects include marked burning and stinging of the treatment site which may necessitate discontinuation of the cream in some patients. Allergic contact dermatitis appears to be frequent, and patients should be monitored for symptoms of hypersensitivity. 

Warnings Safety and efficacy of ciprofloxacin has not been established in children, adolescents, pregnant women, and lactating women Convulsions have been reported in patients receiving ciprofloxacin Serious and fatal reactions have been reported after the co-administration of ciprofloxacin and theophylline Serious hypersensitivity reactions have occurred Pseudomembranous colitis has been reported... 

Re-administration might be an issue for abciximab, due to its inherent immunogenicity. Human antichimeric antibody is detectable in about 5% to 6% patients receiving abciximab therapy, but no antibodies have been observed in response to the small molecules. In practice, re-administration registry of 500 patients showed similar safety and efficacy for repeat administration when compared with first time administration (80). No reports of hypersensitivity or anaphylactic reactions were reported with abciximab re-administration. Thus, these agents can be safely re-administered with careful monitoring of platelet counts, especially with abciximab therapy. 

SAFETY PROFILE A human poison by an unspecified route. Poison experimentally by ingestion, subcutaneous, intramuscular, intravenous, and intraperitoneal routes. Human systemic effects by ingestion nausea, dyspnea, coma, blood pressure elevation, flaccid paralysis without anesthesia, muscle weakness. Normally administered by injection. Poisoning can occur as a result of a mistake in dosage or due to hypersensitivity of the patient within 5 to 25 minutes after administration. Death usually results from respiratory paralysis. Experimental reproductive effects. Combustible when exposed to heat or flame. When heated to decomposition it emits toxic fumes of NOx. See also CARBAMATES. 

Positive human anti-chimeric antibodies have been detected in 6% of patients (generally in low titers) but were not associated with hypersensitivity or allergic reactions. Preliminary data indicate that abciximab can be safety readministered, although a greater incidence of thrombocytopenia after administration has been reported with a lesser efficacy of platelet transfusion (12). 

The efficacy and safety of abacavir (NRTI) and efavirenz (NNRTI) plus background therapy have been retrospectively evaluated in 50 patients, who had previously been treated with HAART (3). There was some immunological benefit, albeit limited, in most of the patients. Adverse effects were not mentioned in detail, but the dropout rate during the first 4 weeks of treatment was high, owing to skin rashes and hypersensitivity reactions. 

The safety and efficacy of a fixed combination of pyrimethamine 25 mg + sulfadoxine 500 mg, supplemented with folinic acid 15 mg, both twice a week, as primary prophylaxis of Pneumocystis pneumonia and Toxoplasma encephalitis has been evaluated in 106 patients infected with HIV in a single-arm, open, prospective study (17). There were allergic reactions in 18 patients and permanent withdrawal was required in seven. One patient who took continued prophylaxis despite progressive hypersensitivity reactions developed a serious adverse reaction (Stevens-Johnson syndrome). 

Despite a good overall safety profile, anti-TNF antibodies can induce a number of adverse effects, including autoimmunity and infections. A trial in the treatment of Crohn s disease noted infusion reactions, transient increased of anti-dsDNA antibodies, and serum sickness-like delayed hypersensitivity with retreatment. Induction of human-antichimeric-antibodies was suggested as the cause of some of the infusion reactions [90]. A prospective study in 35 patients with Crohn s disease showed induction of ANA and anti-dsDNA autoantibodies in 53% and 35% of infliximab-treated patients [91]. A single patient showed clinical features consistent with drug-induced lupus, including the presence of ANA and anti-dsDNA autoantibodies, which quickly resolved after discontinuation of infliximab. Reports on renal adverse effects of anti-TNF antibodies are very rare. Saint Marcoux described the occurrence of crescentic GN in as few as 2 patients out of a cohort of 39 patients, treated with an anti-TNF antibody for rheumatoid arthritis [92]. A case report by Chin et al. [93] described the case of a 29-year-old Australia-born Vietnamese who presented with nephrotic syndrome. A renal biopsy showed membranous nephropathy. Symptoms attenuated after discontinuation of infliximab therapy. 

Caumes E, Guermonprez G, Lecomte C, et al. Efficacy and safety of desensitization with sulfamethoxazole and trimethoprim in 48 previously hypersensitive patients infected with human immunodeficiency virus. Arch Dermatol 1997 133 465 69. 

Oxyphenbutazone, a NSAID (300 to 600 mg/day in divided doses), is indicated in pain and inflammation of arthritis and ankylosing spondylitis. Oxyphenbutazone, a metabolite of phenylbutazone, has analgesic, antipyretic, antiinflammatory, and uricosuric properties. Oxyphenbutazone is absorbed orally, is bound to plasma proteins to the extent of 98%, has a half-life of 50 to 100 hours, is metabolized in the liver, and is excreted by the kidneys. Oxyphenbutazone is contraindicated in patients with known hypersensitivity to phenylbutazone in patients in whom aspirin or other NSAIDs induce symptoms of asthma, urticaria, or rhinitis in patients under age 14 because safety has not been established and in patients... 

The cutaneous reaction caused by allopurinol is predominantly a pruritic, erythematous, or maculopapular eruption, but occasionally the lesion is urticarial or purpuric. Rarely, toxic epidermal necrolysis or Stevens-Johnson syndrome occurs, which can be fatal. The risk for Stevens-Johnson syndrome is limited primarily to the first 2 months of treatment. Because the rash may precede severe hypersensitivity reactions, patients who develop a rash should discontinue allopurinol. If indicated, desensitization to allopurinol can be carried out starting at 10—25 fjbg/day, with the drug diluted in oral suspension and doubled every 3—14 days until the desired dose is reached. This is successjul in approjdmately half of patients. Oxypurinol is available for compassionate use in the U.S. for patients intolerant of allopurinol. The safety of oxypurinol in patients with severe allopurinol hypersensitivity is unknown it is not recommended in this setting. 

Manfredi R, Calza L (2007) Safety issues about nevirapine administration in HIV-infected pregnant women. J Acquit Immune Defic Syndr 45 365-368 Maniar JK, Shah SR, Verma R, Kamath R, Gupte P, Maniar A (2006) Nevirapine-induced fulminant hepatitis. J Assoc Physicians India 54 957-961 Martin AM, Nolan D, James I, Cameron P, Keller J, Moore C, Phillips E, Christiansen FT, Mallal S (2005) Predisposition to nevirapine hypersensitivity associated with HLA-DRB 1 0101 and abrogated by low CD4 T-cell counts. AIDS 19 97-99 Mary Ann Liebert, Inc. (2001) Antiviral briefs. AIDS Patient Care and STDs 15 103-104 Masson MJ, Uetrecht JP (2004) Tolerance induced by low dose d-penicillamine in the Brown Norway rat model of drug-induced autoimmunity is immune-mediated. CRT 17 82-94... 

Bavbek S, Dursun AB, Dursun E, Eryilmaz A, MisirUgil Z. Safety of meloxicam in aspirin-hypersensitive patients with asdraia and/or nasal polyps. IntArch Allergy Immunol (2007) 142, 64-9. 

If in doubt from the history of the patient, the only way to determine hypersensitivity is through provocation tests. A challenge test battery with several controls is used (Table 3). We prefer to have patients in the hospital for their own safety and so that they can be followed closely during the 2-week test period. The time in the hospital may prove less than the loss of working days from the urticaria itself. 

Caimmi S, Gal6ra C, Bousquet-Rouanet L, Arnoux B, Demoly P, Bousquet PJ. Safety of cefuroxime as an alternative in patients with a proven hypersensitivity to penicillins a DAHD cohort survey. Int Arch Allergy Immunol 2010 153(1) 53-60. 

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