Adverse Reactions to Furazolidone and Other Drugs. a Comparative Review

Adverse Reactions to Furazolidone and Other Drugs A Comparative Review

A. ALTAMIRANO & A. BONDANI Norwich Eaton S.A. de C.V., Mexico City, Mexico

Altamirano A, Bondani A. Adverse reactions to furazolidone and other drugs. A comparative review. Scand J Gastroenterol 1989, 24(suppl 169), 70-80

Furazolidone is a synthetic nitrofuran with a broad spectrum of antimicrobial action and has been widely used in the treatment of gastrointestinal infections. This article reviews the adverse reactions to furazolidone reported in the world literature. Of 10,443 adults and children who were treated with the drug, approximately 8.3% (864) experienced such reactions. Because some of these patients had more than 1 adverse reaction, 1178 reactions were reported in these studies. Nausea with vomiting, the commonest adverse reaction, was reported by 51% of the 864 patients who experienced adverse reactions. The authors compare the adverse reactions to furazolidone with those reported for other antimicrobial and antiprotozoal drugs that are frequently used to treat gastrointestinal infections.

Key words: Adverse reactions; ampicillin; furazolidone; trimethoprim-sulfamethoxazole

A. Altamirano, M.D., Medellin 273 - 1" Piso, Col. Roma Sur, C . P . 06770, Mexico D.F., Mexico

Furazolidone is a synthetic nitrofuran that is active against a broad spectrum of gram-negative and gram-positive bacteria and some protozoa, including Giardia lamblia. The bactericidal activity of furazolidone is the result of its ability to inhibit various bacterial enzymes, especially those involved in the Krebs cycle.

For more than 30 years, furazolidone has been used to treat gastrointestinal tract infections, including typhoid fever, shigellosis, salmonel- losis, cholera, bacterial gastroenteritis, and giar- diasis (1). Chamberlain (2) and Carlson et al. (3) reported that furazolidone was highly active in vitro against various enteropathogens, including Campylobacter jejuni, Enterobacter sp, Escher- ichia coli, Klebsiella pneumoniae, Shigella sp, Vibrio cholerae, V . parahaemolyticus, and Yer- sinia enterocolitica; some species of Bacteroides, Salmonella (including S. typhi), Staphylococcus, Streptococcus, and Proteus; Giardia lamblia; and some species of Trichomonas.

Rabin & Lockerby (4) reported in 1984 that many surveys of bacterial resistance patterns

showed an extremely low level of resistance to furazolidone in comparison with other antimicrobial agents and that this pattern has not changed significantly over the years. Further- more, because furazolidone does not significantly alter normal bowel flora, its use does not result in overgrowth or superinfection by other bacteria or fungi-a phenomenon that commonly occurs during or after the use of antimicrobial drugs

In 1986 Griffin & Weber (5) published a survey of the systems used to report spontaneous adverse reactions in 16 countries, including Australia, Belgium, Italy, Japan, The Netherlands, New Zealand, Norway, Sweden, the United Kingdom, and the United States. Two drugs that are widely used to treat gastrointestinal infections-trimethoprim-sulfamethoxazole (TMP-SMX) and ampicillin-appeared most consistently in national lists of the 10 drugs most often associated with adverse reactions. Some countries listed ampicillin as the most frequent cause of adverse reactions.

(1,2).

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Adverse Reactions to Furazolidone 71

This article reviews the adverse reactions to furazolidone that have been reported in the literature since 1955, when the drug was introduced. Included in the review are 191 clinical studies, case reports, letters to the editor, and anecdotal reports in which the frequencies of adverse reactions to furazolidone were quantified (6-196). Articles that did not report the frequencies of these reactions were excluded.

For the purposes of data gathering, we assumed that in the publications citing only the number of reactions, that number was synonymous with the number of patients who had the reactions. Adverse reactions cited as symptoms of the same syndrome (e.g., pulmonary reaction syndrome or peripheral neuropathy) were counted individu- ally.

When the review was completed, the frequency of a specific reaction was computed as the per- centage of the total number of patients treated who experienced the reaction. The frequencies of adverse reactions to furazolidone were then compared with those cited in the literature for other antimicrobial and antiprotozoal drugs used to treat gastrointestinal infections. Because we were aware that the frequencies of adverse reactions to furazolidone and the other drugs were, in many instances, not comparable, our primary goal was to call attention to the relative frequencies of common and uncommon adverse reactions to the drugs, not to establish accurate incidences of such reactions.

ADVERSE REACTIONS TO FURAZOLIDONE AND OTHER SELECTED DRUGS

Gastrointestinal reactions By far the commonest adverse reactions to

furazolidone were gastrointestinal in nature-for example, nausea and vomiting, nausea without vomiting, abdominal pain, and diarrhea (Table I). As shown in the table, the overall frequency of gastrointestinal reactions in the total sample was 8%. Such reactions were reported for 842 of the 864 patients who experienced adverse reactions. Some of these patients had received doses that were higher than the therapeutic doses of 5 to 7 mg/kg/day, and most of them had infectious gastrointestinal diseases in which symptoms of the disease could be difficult to distinguish from an adverse reaction. Gastrointestinal intolerance diminished if the drug was given with food.

The frequencies of gastrointestinal reactions to furazolidone found in our survey compared favorably with those reported for other drugs used to treat gastrointestinal infections. The commonest gastrointestinal adverse reactions that have been reported with chloramphenicol are nausea and vomiting, diarrhea, anorexia, and nausea without vomiting, with an overall occurrence of 10% (183,197). TMP-SMX has been associated with nausea and vomiting, anorexia, nausea without vomiting, abdominal pain, glossitis, stomatitis, and diarrhea at frequencies ranging from 3% to 26% (198-202). In two reports the frequencies of adverse reactions to ampicillin, including diarrhea, nausea, vomiting, and abdominal pain, ranged from 5% to 17%; pseudo-

Table I. Frequency of adverse gastrointestinal reactions to furazolidone (n = 10,443)'

No. of Frequency Reaction reports (%I

Among 10,443 patients treated with furazolidone Nausea and vomiting 443 4.24 who were cited in the 191 publications, 4760 Nausea 165 1.58

56 0.54 (45.6%) were children ranging in age from a few months to 15 years, and 1571 (15%) were adults. Diarrhea 35 0.34

Abdominal pain 126 1.21 Anorexia

The ages of the remaining 4112 patients (39.4%) Heartburn 13 0.12 Regurgitation 2 0.02

were experienced by 8.3% (864) of the 10,443 Steatorrhea 1 0.01 1 0.01 were not specified. Adverse reactions to the drug

patients. Some patients had more than 1 reaction; 842 8.06 the overall number of adverse reactions reported was 1178.

= number of patients treated with furs- zolidone in the literature reviewed.

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72 A. Altamirano & A. Bondani

membranous colitis was an extermely rare occurrence (203, 204). Adverse gastrointestinal reactions associated with metronidazole-nausea and vomiting, abdominal pain, nausea without vomiting, diarrhea, metallic taste in the mouth, stomatitis, and glossitis-were reported at frequencies of 7% to 20% (205,198). One study reported that quinacrine caused nausea and vomiting, abdominal pain, and nausea without vomiting at an overall frequency of 23% (206).

Neurologic reactions Among the 864 patients who experienced

adverse reactions to furazolidone, 140 experienced reactions involving the nervous system; the frequency in the total sample was 1.34%. As shown in Table 11, headache (0.72%), vertigo (0.30%), and giddiness (0.23%) were the commonest complaints in this category. Other reactions such as insomnia, psychomotor agitation, and neurotoxicity were rarely observed; together, they accounted for less than 0.1% of all adverse reactions.

Many antimicrobial and antiprotozoal agents produce neurologic reactions. At doses of 4 to 8g/day (the recommended dose for adults is 50 mg/kg/day) chloramphenicol has been associated with mental disturbances similar to those observed in hepatic encephalopathy, including lethargy, asterixis, confusion, and memory dis-

Table 11. Frequency of adverse neurological reactions to furazolidone (n = 10,443)*

No. of Frequency Reaction reports (%I

Headache 75 0.72 Vertigo 31 0.30 Giddiness 24 0.23 Insomnia 3 0.03 Acute psychosis 1 0.01 Drowsiness 1 0.01 Neurotoxicosis 1 0.01 Paresthesia 1 0.01 Peripheral neuropathy 1 0.01 Psychomotor agitation 1 0.01 Trigeminus neuralgia 1 0.01 Total 140 1.34

* n = The number of patients treated with furazolidone in the literature reviewed.

turbances (207). TMP-SMX has been associated with meningitis, headache, depression, confusion, hallucinations, paresthesias, polyneurop- athy, and other neurologic reactions at a frequency of 1.7% (202, 208). The administration of metronidazole has been related to dizziness, vertigo, headache, paresthesias, and, in rare cases, lack of coordination and ataxia (209). In two studies, quinacrine was associated with dizziness, headache, retinopathy, and toxic psychosis in adults at a frequency of 1.5% (210,211). Tetracycline has been associated with benign intracranial hypertension in children, and the sulfonamides have been associated with allergic meningitis in rare instances (212).

Aminoglycosides have been associated with ototoxicity resulting from vestibular and auditory dysfunction. Although the incidence of ototoxicity associated with gentamicin was reported to be 2% or 3% (213,214), more detailed measurements of eighth-nerve function indicated that audiologic damage may increase from 10% to 20% (215,216). Our review produced one report of deafness after the use of furazolidone (59); the patient recovered completely after the drug was withdrawn.

Systemic reactions The systemic reactions to furazolidone reported

in the literature we reviewed are summarized in Table 111. Fifty-nine of the 864 patients experienced such reactions. The frequency in the total sample was 0.56%.

Among a range of reactions that included fever, ischialgia-like pain, angioneurotic edema, and impaired vision, fever was the one most commonly observed (35 patients complained of fever, for an overall frequency of 0.34%). Fever can occur as an isolated manifestation of drug allergy. Other drugs cited in the literature as causing fever were sulfonamides and ampicillin (217,218). In 1985 the Swedish Board of Health and Welfare Committee on Side Effects of Pharmaceutical Preparations reported that among 1234 patients who experienced adverse reactions to TMP- SMX, 264 (21.3%) developed fevers (208). No reports of systemic anaphylaxis associated

with furazolidone were found in the literature we

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Adverse Reactions to Furarolidone 73

Table 111. Frequency of adverse systemic reactions to furazolidone (n = 10,443)*

No. of Frequency Reaction reports ("/.I

Fever Malaise Ischialgia-like pain Arthralgia Backache Itching Serum sickness Blurring of vision Burning feeling in body Deafness Hypertonia Impairment of vision Angioneurotic edema Total

35 7 3 2 2 2 2 1 1 1 1 1 1

59

0.34 0.07 0.03 0.02 0.02 0.02 0.02 0.01 0.01 0.01 0.01 0.01 0.01 0.56


reviewed. Cephalosporins and penicillins, including ampicillin, can cause anaphylaxis, and because they are used extensively, they are responsible for an incidence of reactions believed to be between 0.01% and 0.04% (219). Approximately 0.002% of patients treated with these agents die of anaphylaxis (220). Sulfonamides and tetracycline have also been associated with this adverse reaction (219). Although usually associated with par- enteral administration of a drug, systemic anaphylaxis also can occur after oral administration.

Serum sickness-a systemic allergic reaction characterized by urticaria, angioedema, arthral- gias with articular edema, fever, lymphadeno- pathy, and sometimes nephritis-is mediated by IgG antibodies and usually appears a week or more after treatment with the causative agent has been discontinued (219). We found only two reports of serum sickness after the use of furazolidone (184). The authors speculated that both cases were related to tartrazine (yellow dye number 5 ) , formerly contained in tablets of the drug. Currently, furazolidone tablets manufactured in the United States and in Latin America (under licensing of Norwich Eaton Pharmaceuticals, Inc.) do not contain tartrazine. Both patients were treated with corticosteroids, and neither patient had residual lesions. Serum sickness

also has been observed during or after treatment with sulfonamides, tetracycline, and ampicillin (217,218).

Dermatologic reactions Dermatologic reactions are among the most

frequent adverse reactions associated with the administration of drugs. Of these, exanthemas (maculopapular, morbilliform, and erythematous eruptions) are the commonest. However, their frequency varies. One study reported that 2% to 3% of patients treated with any drug developed such reactions (221); another reported that such reactions occurred in 46% of 464 patients (222). Because patients often receive several drugs simultaneously, it can be difficult to attribute a dermatologic reaction to a particular drug.

Adverse dermatologic reactions to furazolidone were observed in 56 of the 864 patients who experienced adverse reactions-a frequency of 0.54% in the total sample (Table IV). Skin eruptions (40 reports) were commonest, followed by pruritus (13 reports) and erythema multiforme (3 reports).

In other studies the following frequencies were reported for other drugs: TMP-SMX, 5.9% (221,223); ampicillin, 5.2% (221,223); amox- icillin, 5.1% (224); gentamicin, 4.5% (224); sulfonamides, 1.7% (221); chloramphenicol, 0.6% (221,223); and tetracycline, 0.4% (224). Metro- nidazole has also been associated with such reactions, but the frequency has not been determined (212). One study found that quinacrine was associated with yellow discoloration of the skin at a frequency of 4% to 5% (210); two reports stated that the drug was associated with exfoliative der-

Table IV. Frequency of adverse dermatologic reactions to furazolidone (n = 10,443).


~~~~~~ ~~~ ~

Skin eruptions 40 0.38 Pruritus 13 0.12 Erythema multiforme 3 0.03 Total 56 0.54


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74 A . Altamirano & A . Bondani

matitis, but the frequency was not reported

In the literature we reviewed, no cases of Ste- vens-Johnson syndrome (major erythema multiforme) were reported for furazolidone. This syndrome has been associated with the use of sulfonamides, ampicillin, chloramphenicol, tetracycline, and metronidazole (160,217,225), but the frequency has not been determined. Fura- zolidone also was not associated with toxic epi- dermal necrolysis or exfoliative dermatitis, reactions that have been associated with tetracycline, sulfonamides, TMP-SMX, ampicillin, neomycin, and quinacrine (160,217,218).

As was mentioned earlier, the literature contained three reports of erythema multiforme (160) related to furazolidone. This reaction has also been associated with ampicillin, chloramphenicol, sulfonamides, tetracycline, and TMP-SMX and with many other drugs that were not included in the review (225), but the frequencies have not been determined.

(210,212).

Hematologic reactions In our review we found 38 reports of hema-

tologic abnormalities associated with furazolidone--0.36% of the total sample (Table V). As Table V shows, leukopenia and changes in hemoblobin were the two commonest reactions. Most of the reactions listed were transient and without clinical significance. No reports of bone marrow aplasia (aplastic anemia) were recorded.

Of all the drugs that may be responsible for

Table V. Frequency of adverse hematologic reactions to furazolidone ( n = 10,443)*


Changes in hemoglobin 9 0.09 Eosinophilia 6 0.06 Hemolytic anemia 4 0.04 Anemia 1 0.01 Leukocytosis 1 0.01 Purpura 1 0.01 Total 38 0.36

Leukopenia 16 0.15


aplastic anemia, chloramphenicol is the most frequently reported one (226); indeed, the most important adverse reactions to chloramphenicol involve the bone marrow. The incidence of aplastic anemia is low (1 in 21,000 to 1 in 36,000 courses of therapy) (226), but the fatality rate can be as high as 70% (227). Other hematologic adverse reactions that have been associated with chloramphenicol are hypoplastic anemia, bone marrow inhibition, thrombocytopenia, and agranulo- cytosis (228).

One in 50,000 courses of treatment with quinacrine has been associated with aplastic anemia. The risk of developing this condition after exposure to quinacrine is reportedly 10 times greater than it is without exposure (228). Other blood dyscrasias associated with quinacrine are hemolytic anemia and thrombocytopenia (225).

The hematologic reactions reported for TMP- SMX include various types of anemia (e.g., aplastic, hemolytic, and macrocytic), coagulation dis- orders, granulocytopenia, sulfhemoglobinemia, eosinophilia, thrombocytopenia, and leukopenia (202,229,230). In one study the overall incidence of hematologic reactions to TMP-SMX was 15% (208). Adverse reactions to the sulfonamides are similar to those observed with TMP-SMX (229).

Although no serious hematologic reactions have been recorded concerning metronidazole, significant neutropenia has been reported. Neu- trophil levels return to normal, however, when the course of treatment is completed (209). Tetra- cyclines have been associated with leukopenia, hemolytic anemia, pancytopenia, and, in a few cases, thrombocytopenia (225).

In our review we found four reports of hemolytic anemia associated with furazolidone in patients deficient in glucose-6-phosphate dehydrogenase (69,127,134,153); the incidence of this reaction was 0.04%. Patients deficient in this enzyme who were treated with furazolidone did not always develop hemolytic anemia (or hepatic abnormalities) (170,231, 232).

Cardiovascular, pulmonary, and orallpharyngeal reactions

Cardiovascular adverse reactions were reported for 12 of the 864 patients who reacted

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Table VI. Frequencies of adverse cardiovascular, pulmonary, and oral/pharyngeal reactions to furazolidone (n = 10,443)*

No. of Frequency Reaction reports (%)

Oral/pharyngeal reactions to furazolidone were reported in eight patients, or fewer than 0.08% of the total sample (Table VI). Four of the patients complained of dry mouth or a coated or white, fuzzy tongue.

Cardiovascular Heart palpitations 4 0.04 Postural hypotension 4 0.04 Facial flushing 2 0.02 Tachycardia 2 0.02 Total 12 0.11

Pulmonary Asthma 6 0.06 Acute pulmonary reaction 5 0.05 Total 11 0.11

Oral/pharyngeal Coated or white,

fuzzy tongue 2 0.02 Dry mouth 2 0.02 Bitter taste in mouth 1 0.01 Cheiloses 1 0.01 Hyperemia, plus edema

of the tongue 1 0.01 Laryngitis 1 0.01 Total 8 0.08


adversely to furazolidone-an incidence of 0.11% in the total sample (Table VI). Four of these patients experienced postural hypotension, and four had heart palpitations. The clinical significance of all 12 cardiovascular reactions was nil. Sulfonamides and chlortetracycline, however, can cause myocardial damage as a result of hyper- sensitivity reactions (225).

As shown in Table VI, 11 patients had adverse pulmonary reactions to furazolidone, an overall incidence of 0.11%. Six of these patients has asthma-like symptoms (195). The others had acute pulmonary reactions; these reactions were characterized by dyspnea, pleuritic chest pain, and diffuse pulmonary infiltrates (160,173,175). The sulfonamides have been linked to pulmonary infiltration with eosinophilia (233); gentamicin has been linked to respiratory muscle paralysis (233,234); TMP-SMX to pulmonary hyper- sensitivity and lung fibrosis (208); and tetracycline to asthma (225).

Hepatic and renal reactions Hepatic adverse reactions associated with fura-

zolidone were reported in six patients, repre- senting 0.06% of the total sample (Table VII). Five of the patients developed jaundice, and one experienced hepatic dysfunction. We found no reports of hepatomegaly or necrosis associated with furazolidone.

Under certain circumstances many drugs used to treat gastrointestinal infections can damage the liver. Occasionally, hepatotoxic drugs may cause hepatic manifestations, including jaundice, hepatomegaly, and necrosis. Among the antimicrobial and antiprotozoal drugs reported to cause hepatic reactions were chloramphenicol, tetracycline, the sulfonamides, and TMP-SMX (217,225,235).

Renal adverse reactions also were reported in six patients taking furazolidone (frequency, 0.06%) (Table VII). Five reports cited deterior- ation of analyses of the urine (168); the remaining report cited oliguria/nephritis (162), which gradu- ally improved without residual damage. Kidney damage is a serious hazard of medication for gastrointestinal infections. Tetracycline and sulfonamides also have been associated with neph- rotoxicity (217). Although TMP-SMX is not considered to be particularly nephrotoxic, it can cause mild increases in serum creatinine (236), and in patients with underlying renal disease the drug can cause marked increases in serum creatinine and urea nitrogen, suggesting neph- rotoxicity (237).

Other adverse reactions Dkulfuran-like reaction to alcohol. It is known

that patients who consume alcohol while taking furazolidone can develop a disulfuran-like reaction characterized by flushing, a slight fever, dyspnea, and, in some instances, a sense of constriction in the chest (1,238). The symptoms disappear within 24 h after ingestion of alcohol ceases. Disulfuran-like reactions have also been

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Table VII. Frequencies of hepatic and renal adverse reactions to furazolidone (n = 10,443).

Reaction No. of Frequency reports (%I

Hepatic Jaundice 5 0.05

Total 6 0.06 Hepatic dysfunction 1 0.01

Renal Abnormalities of urine 5 0.05

Total 6 0.06 Oliguria or nephritis 1 0.01


reported in connection with chloramphenicol, quinacrine, and metronidazole (239,240).

Hypertensive episodes. Because furazolidone is a monoamine oxidase (MAO) inhibitor in humans, it theoretically can precipitate a hypertensive crisis if large doses of the drug are com- bined with certain other M A 0 inhibitors or with foods containing tyramine (241,242). If furazolidone is to be administered in larger-than- recommended doses or for longer than 5 days, patients should be informed about the possibility of adverse reactions caused by MAO-inhibitor drugs and certain foods.

Alteration of normal flora. According to the articles we reviewed (12,190,243), furazolidone does not alter normal flora. In contrast, ampicillin, chloramphenicol, gentamicin, metronidazole, neomycin, the sulfonamides, tetracycline, and TMP-SMX have been associated with superinfections secondary to their effect on normal flora (204,244-246). Although the effects of antimicrobial and antiprotozoal drugs on the intes- tinal flora are not precisely characterized as adverse reactions, these effects are of great importance because they can predispose the microorganisms to develop resistance to antimicrobials and to superinfection by resistant bacteria or fungi. Vaginal, oral, pharyngeal, and even systemic infections caused by opportunistic organisms may follow the use of broad-spectrum antimicrobials, mainly in individuals who already have some predisposing condition.

Mortality No deaths associated with adverse reactions

to furazolidone were reported in the literature reviewed. This contrasted with reports about other antimicrobial agents. For example, the Committee on Safety of Medicines in Great Brit- ain (247) stated that TMP-SMX was associated with death in 85 patients, primarily after the development of blood dyscrasias (50 reports) and skin reactions (14 reports). Analysis of these reports showed that the death rate increased markedly with age. Ampicillin has been associated with death in 22 patients. Seven of the 22 reports involved colitis or pseudomembranous colitis, and 4 involved skin reactions; the others cited anaphylactic reactions, blood dyscrasias, and superinfections (245,247).

Chloramphenicol has been associated with deaths caused by aplastic anemia. The fatality rate is higher when bone marrow aplasia is com- plete and those who recover have a high incidence of acute leukemia (226,244). Several authors (227,244) reported that neonates exposed to high doses of chloramphenicol may develop a severe reaction called 'gray syndrome', which results in the death of about 40% of affected patients. The aminoglycosides, including gentamicin, have been associated with death resulting from renal insufficiency and superinfections (244,245). Deaths secondary to sulfonamide- induced skin eruptions (225) and to hepatic damage caused by tetracyclines (248) have also been reported.

IMPLICATIONS

As this review demonstrates, most of the adverse reactions to furazolidone described in the 191 publications were mild, and only in rare cases did they necessitate discontinuation of treatment. Because most of the frequencies reported for other antimicrobials and antiprotozoal agents that are often used to treat gastrointestinal infections were obtained from published sources other than the 191 dealing with furazolidone, it is difficult to make direct comparisons. However, we believe that the frequencies listed for the other drugs

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are representative of the rates at which adverse reactions occur.

The expanding body of literature on adverse drug reactions in recent years provides evidence that, in many cases, physicians d o not sufficiently weigh the risks inherent in administering a drug against the benefits of its use, A more thorough understanding of the risks associated with various drugs should serve as a deterrent to the pre- scription of powerful agents for minor conditions.

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Adverse Reactions to Furazolidone and Other Drugs. a Comparative Review

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