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Population-Based Drug-Induced Agranulocytosis

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Population-Based Drug-Induced Agranulocytosis ORIGINAL INVESTIGATION Population-Based Drug-Induced Agranulocytosis Luisa Ibáñez, MD; Xavier Vidal, MD; Elena Ballarín, RN; Joan-Ramon Laporte, MD Background: Since the publication of a major interna- late (OR, 77.84 [95% CI, 4.50-1346.20]), antithyroid tional case-control study on the risk of agranulocytosis drugs (OR, 52.75 [95% CI, 5.82-478.03]), dipyrone (met- associated with the use of medicines in the 1980s, many amizole sodium and metamizole magnesium) (OR, 25.76 new drugs have been introduced in therapeutics. [95% CI, 8.39-179.12]), and spironolactone (OR, 19.97 [95% CI, 2.27-175.89]). Other drugs associated with a Methods: Seventeen units of hematology contribute to significant risk were pyrithyldione, cinepazide, aprin- the case-control surveillance of agranulocytosis and aplas- dine hydrochloride, carbamazepine, sulfonamides, phe- tic anemia in Barcelona, Spain. After a follow-up of 78.73 nytoin and phenytoin sodium, ␤-lactam antibiotics, eryth- million person-years, 177 community cases of agranu- romycin stearate and erythromycin ethylsuccinate, and locytosis were compared with 586 sex-, age, and hospital- diclofenac sodium. Individual attributable incidences for matched control subjects with regard to previous use of all these drugs, which collectively accounted for 68.6% medicines. of cases, were less than 1:1 million per year. Results: The annual incidence of community-acquired Conclusions: Agranulocytosis is rare but serious. A few agranulocytosis was 3.46:1 million, and it increased with drugs account for two thirds of the cases. Our results also age. The fatality rate was 7.0%, and the mortality rate was provide reassurance regarding the risk associated with a 0.24:1 million. The drug most strongly associated with number of newly marketed drugs. a risk of agranulocytosis was ticlopidine hydrochloride with an odds ratio (OR) of 103.23 (95% confidence in- terval [CI], 12.73-837.44), followed by calcium dobesi- Arch Intern Med. 2005;165:869-874 GRANULOCYTOSIS IS A SERI- ence from clinical trials, anecdotal re- ous condition, with an es- ports, and series of cases have suggested timated incidence of 1.6:1 that certain drugs, namely, antithyroid million to 7.0:1 million in- drugs,13 ticlopidine hydrochloride,14,15 spi- habitants per year.1,2 Case ronolactone,16 and clozapine,17,18 are po- Afatality is around 10%,3,4 but this may de- tential causes. pend to a large extent on the availability The metropolitan area of Barcelona, of prompt antibiotic treatment. Almost all Spain, was one of the regions participat- classes of medicines have been impli- ing in the 1980-1986 IAAAS. Since the cated in agranulocytosis. Although it has completion of the international study, data been suggested that more than two thirds collection and analysis continued in our Author Affiliation: Fundació 4 Institut Català de Farmacologia, of cases are attributable to medicines, the region, with the same methods. We pre- World Health Organization evaluation of the etiologic role of these is sent the results of the case-control epide- Collaborating Centre for challenging, because the disease is rare and miological surveillance of agranulocyto- Research and Training in the prevalence of use of the medicines of sis during 22 years in a population of 4 Pharmacoepidemiology interest is generally low. Since the Inter- million inhabitants. (Drs Ibáñez, Vidal, and Laporte national Agranulocytosis and Aplastic Ane- and Ms Ballarín), and mia Study (IAAAS) was carried out in the METHODS Department of Pharmacology, 1980s,2,5 patterns of pharmaceutical con- Therapeutics, and Toxicology, sumption have changed, and many of the Universitat Autònoma de medicines marketed in the past 20 years In 1980, a population-based case-control Barcelona (Drs Ibáñez, Vidal, scheme for the surveillance of agranulocyto- and Laporte), Clinical have reached a significant prevalence of sis and aplastic anemia was established in the Pharmacology Service, Hospital use. In the past 2 decades, several epide- metropolitan area of Barcelona, with 17 par- Universitari Vall d’Hebron, miological studies have confirmed some ticipating hospital hematology units. The Barcelona, Spain. previous findings4,6-9 or have uncovered scheme covered a population of 3.3 to 4.1 mil- Financial Disclosure: None. drugs with a potential risk.10-12 Experi- lion inhabitants (described in detail in http: (REPRINTED) ARCH INTERN MED/ VOL 165, APR 25, 2005 WWW.ARCHINTERNMED.COM 869 ©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/01/2021 //www.icf.uab.es/farmavigila/protocols/agranulodrugs.htm). This spironolactone, antithyroid drugs, phenytoin, carbamazepine, sul- network was part of the IAAAS, which was carried out in sev- fonamides (including the combination of trimethoprim and sul- eral European regions from 1980 to 1986. Data presented in famethoxazole, and sulfasalazine), β-lactam antibiotics, erythro- this report correspond to the period from July 1, 1980, to June mycin (stearate and ethylsuccinate), and a group of drugs with 30, 2001. The methods have been described in detail else- relatively low levels of consumption that are known to cause where.2,5,19 agranulocytosis (ie, aprindine [hydrochloride], cinepazide, clo- With the aim of identifying all cases of agranulocytosis oc- pidogrel, clozapine, calcium carbimide [cyanamide], gold salts, curring in the study population, our center maintains regular mianserin [hydrochloride], and pyrithyldione). The pharmaco- contact with all hospitals in the area, through weekly or bi- logical terms included in the model were chosen because they weekly telephone calls to a designated contact person in the were well-established potential causes of agranulocytosis, or hematology laboratory. Potential cases were patients with a because they showed a higher prevalence of use among the cases granulocyte count of less than 500/mm3 or a total white blood compared with the controls. cell count series of less than 3000/µL in 2 consecutive counts, The primary analysis was performed with a conditional mul- with a hemoglobin level of at least 10 g/dL and a platelet count tiple logistic regression model. However, with the aim of in- of at least 100 ϫ103/µL. A bone marrow aspirate or a biopsy creasing statistical power for estimation of the risk associated sample was generally required, but it was not mandatory if all with drugs having a low prevalence of use, a second analysis other diagnostic criteria were met and if the neutrophil count was done with all the cases for which information on drug ex- was within the reference range within 30 days. Primary exclu- posures was available, and all the controls of both agranulo- sion criteria were applied to patients receiving chemotherapy cytosis and aplastic anemia, with an unconditional model that for cancer, radiation therapy, or immunosuppressive drugs; those included sex, age, and interviewer as additional terms. Drug with hypersplenism, lupus erythematosus, leukemia, lym- exposures were considered in different ways. The main analy- phoma, megaloblastic anemia, or AIDS; asymptomatic cases dis- sis refers to any exposure during the week before the index day; covered coincidentally by complete blood cell counts per- this definition of exposure was decided after taking into ac- formed for other reasons (eg, routine preoperative blood cell count that for most of the cases of agranulocytosis, the time count); and those younger than 2 years (among whom a sig- elapsed from injury of the bone marrow or of peripheral neu- nificant proportion of cases of neutropenia are of viral origin). trophils to the appearance of the initial symptoms of infection Secondary exclusion criteria were applied to patients who could is usually less than 7 days. The following 2 additional confir- not be interviewed during the first 28 days of hospital stay (to matory analyses were performed: one, with the aim of explor- avoid memory bias); those with psychiatric conditions, blind- ing possible information bias (regarding each drug that was used ness, or deafness (because the interview would not be reli- at least 3 days in the preceding week), and the other, to evalu- able); and those living in a nursing home (because they rarely ate protopathic bias (regarding each drug that was used be- know the names of the drugs they take). Because of the diffi- tween 9 and 3 days before the index day) (described in detail culty of establishing acceptable criteria for the selection of ad- at http://www.icf.uab.es/farmavigila/protocols/agranulodrugs equate controls for in-hospital cases of agranulocytosis with- .htm). out incurring selection bias, in-hospital cases were excluded For drugs showing ORs significantly higher than 1, popu- from the case-control analysis. lation-attributable risks were calculated from the OR, with the ϫ Initially, for each case of agranulocytosis or aplastic ane- formula AR=[Pce (OR–1)]/OR, where AR is the attributable mia, we selected no more than 4 controls matched by sex, age, risk and Pce is the proportion of exposed cases. We calculated and hospital in the 3 months after admission of the correspond- 95% confidence intervals (CIs) as described by Greenland.20 ing case, among those of a list of admission diagnoses judged We calculated the overall population-attributable risk by com- independent of the reasons for use of most of the drugs, such bining all exposures to individual drugs that showed a signifi- as non–alcohol-related trauma, asymptomatic conditions need- cant association as a single term. ing surgical treatment, or acute infection. For estimation of incidence, the source population was older The protocol was approved by the ethics committee of the than 2 years. Incidence rates were calculated by age and sex, coordinating hospital. After obtaining informed consent, cases and the attributable incidence (number of cases per million and and controls were interviewed by trained personnel, with a struc- per year) was calculated by multiplying the attributable risk tured questionnaire, during their hospital stay.
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