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Metamizole use among Hispanics in Miami: report of a survey conducted in a primary care setting.

Background: Metamizole (dipyrone) is a myelotoxic, nonsteroidal anti-inflammatory agent that has been banned from the US market since 1979. However, dipyrone may be purchased in some areas of the US. We conducted a survey in a primary care setting in Miami, Florida to determine the prevalence of metamizole possession and use among Hispanics living in this area.

Methods: Participants consisted of 137 Hispanic outpatients interviewed consecutively during a primary care visit in the month of February 2005.

Results: Metamizole was possessed by 28% of the surveyed population. The most common reasons for using dipyrone were pain (72%) and fever (24%). The vast majority of patients had purchased the medication in Latin America (95%), in most instances without a prescription (95%). Nineteen patients (13%) had used the medication during the previous year.

Conclusions: Metamizole is available to Latino immigrants who reside in the US, despite the FDA ban imposed in 1977.

Key Words: metamizole, agranulocytosis, Hispanic Americans.

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Metamizole is a nonsteroidal anti-inflammatory drug widely used in Latin and Central America as an antipyretic and analgesic. The drug was banned by the Federal Drug Administration in 1977 due to its association with agranulocytosis. (1) Although the drug is theoretically unavailable in the US, previous reports have indicated that Latino immigrants have metamizole in their households. (2) Moreover, most doctors in the US are not aware of the existence of this drug and its potential complications. We previously reported the case of a middle-aged Caucasian woman who presented to our facility with neutropenic fever after consuming metamizole. (3) In this paper, we report the results of a survey that was conducted in the outpatient clinic of an academic urban community hospital to establish the prevalence of metamizole possession and use among Hispanics.

Materials and Methods

Patients were eligible for the study if they identified themselves as being Hispanic or were born in Central or South America, and had an appointment to see a primary care physician at Jackson Memorial Hospital during the study period. The survey was conducted during the month of February 2005. Jackson Memorial Hospital is the main teaching hospital affiliated with the University of Miami Miller School of Medicine. The survey was conducted in English, Spanish or Portuguese by two bilingual physicians following the patient's visit with their primary care physician. The survey consisted of six questions, as outlined below:

* Have you ever used metamizole or dipyrone?

* Do you recall what the reason for using the medication was?

* Do you have metamizole or dipyrone in your household? If so, have you purchased the medication in the US?

* Was a prescription required to buy the medicine?

* Have you or anyone in your household used the medication in the past 12 months?

Since metamizole is dispensed under various brand names (Table 1), this information was read to them during the survey. Written informed consent was obtained from each individual. The protocol was approved by the local institutional review board and adhered to the principles outlined in the Declaration of Helsinki.

Results

There were 137 primary care clinic visits by Hispanic patients during the study period, all of whom agreed to participate in the survey. Baseline characteristics of the study population are depicted in Table 2. Unlike previous reports in which Mexican-Americans comprised the largest group, Cuban-Americans represented 47% of our population. Fifty patients (36%) reported having used metamizole at some time, and 19 patients (13%) used the medication during the previous year. Metamizole was available in 28% of the surveyed households. The most common reasons for using metamizole were pain (72%) and fever (24%). The vast majority of patients had purchased the medication in Latin America (95%), in most instances without a prescription (95%). Interestingly, Cuban-Americans were less likely to have used metamizole when compared with other Hispanics (odds ratio = 0.05, 95% CI = 0.01-0.16, P < 0.01). None of the patients recalled having been admitted to the hospital for a hematological condition.

Discussion

The practice by immigrant groups of bringing potentially harmful remedies back from their home countries has been well established. (4-6) Since metamizole has been banned in the US market for more than two decades, many doctors may not be aware of the existence of this drug and its potential toxicity. Agranulocytosis and aplastic anemia, however, are the leading causes of metamizole-related death. The adjusted relative risk of developing neutropenia after metamizole exposure is 25.8 [95% confidence interval (CI), 8.4 to 79.1], and the attributable incidence is 0.56 (0.4-0.8) cases per million inhabitants per year. (7) The risk appears to be greater with prolonged exposure to the drug. (8) The mortality rate associated with an episode of dipyrone-induced agranulocytosis ranges from 7 to 32%. (7-10) It has been estimated that by 2050, Hispanics will represent 25% of the US population. (11) Therefore, becoming competent in cross-cultural communication regarding complementary and alternative agents should be considered a high priority, (12) particularly in areas with a high-density of immigrants.

Metamizole is believed to cause agranulocytosis by creating a novel antigen when one of its metabolites binds to neutrophil membranes. (13) This novel antigen stimulates the production of autoantibodies that cause peripheral and bone marrow destruction of neutrophils and their precursors. Hargis et al elegantly demonstrated that neither metamizole alone nor a sensitized patient's serum is able to suppress the in vitro growth of myeloid cell precursors. However, serum from sensitized patients inhibits the proliferation of these cells when the drug is present in the media, suggesting a hapten antibody-like interaction. (13) There is no specific treatment for metamizole-induced agranulocytosis other than discontinuation of the offending agent. Colony stimulating factors have been used with mixed results. (14-15) A case of bone marrow recovery after treatment with steroids has been reported in the pediatric literature. (16)

Our results are similar to those presented by Taylor et al (4) in San Diego, California and Bonkowsky et al (2) in a pediatric population of Mexican immigrants in Salt Lake City, Utah. They both found that 35% and 20% of surveyed patients, respectively, had taken the medication or still had the medication in their households. Of great concern, in the Bonkowsky study, one quarter of the participants reported buying the medication in Salt Lake City, which is more than 700 miles from the Mexican border. This prompted local authorities to mount a radio and television campaign to discourage the use of dipyrone among Hispanics. In our study, only 5% of patients obtained the medication in the US, mostly in local markets in Latino neighborhoods. Our study did not assess the availability of metamizole in these communities.

In summary, metamizole is available to Latino immigrants who reside in the US, despite the ban imposed by the FDA in 1977. Physicians and public health authorities must remain active in discouraging its use, as well as promoting the use of safer alternatives to metamizole.

Acknowledgments

Dr. Daniel Lichtstein and Dr. John Byrnes for reviewing and correcting the manuscript.

References

1. FDA Consumer Magazine. March-April 2004 Issue. Available at: http://www.fda.gov/fdac/features/2004/204_illegal.html. Accessed January 23, 2006.

2. Bonkowsky J, Frazer K, Buchi K, et al. Metamizole use by Latino immigrants: A common and potentially harmful home remedy. Pediatrics 2002;109:e98.

3. Garcia S, Canionero M, Lopez G. Pharmacology. Pharmacotherapy 2006;26:440-442.

4. Taylor L, Abarca S, Henry B, et al. Use of Neo-melubrina, a banned antipyretic drug, in San Diego, California: a survey of patients and providers. West J Med 2001;175:159-163.

5. Barbassa J, ABC News website. Immigrants Preserve Traditional Remedies. Available at: http://abcnews.go.com/Health/wireStory?id=1451899&CMP=OTC-RSSFeeds0312. Accessed April 10, 2006.

6. Associated Press. Herbal remedies popular among immigrants. Available at: http://msnbc.msn.com/id/8486832. Accessed April 10, 2006.

7. Ibanez L, Vidal X, Ballarin E, et al Population-based drug-induced agranulocytosis. Arch Intern Med 2005;165:869-874.

8. Ibanez L, Vidal X, Ballarin E, et al. Agranulocytosis associated with dipyrone (metamizol). Eur J Clin Pharmacol 2005;60:821-829.

9. Risks of agranulocytosis and aplastic anemia. A first report of their relation to drug use with special reference to analgesics. The International Agranulocytosis and Aplastic Anemia Study. JAMA 1986;256:1749-1757.

10. Heit WF. Hematologic effects of antipyretic analgesics. Drug-induced agranulocytosis. Am J Med 1983;75:65-69.

11. U.S. Census Bureau. Projected Population of the United States, by Race and Hispanic Origin: 2000 to 2050. Available at: http://www.census.gov/ipc/www/usinterimproj/natprojtab0la.xls. Accessed January 23, 2006.

12. Juckett G. Cross-cultural medicine. Am Fam Physician 2005;72:2267-2274.

13. Hargis J, La Russa VF, Redmond J, et al. Agranulocytosis associated with "Mexican aspirin" (dipyrone): evidence for an autoimmune mechanism affecting multipotential hematopoietic progenitors. Am J Hematol 1989;31:213-215.

14. Delannoy A, Gehenot M. Colony-stimulating factor and drug-induced agranulocytosis. Ann Intern Med 1989;110:942-943.

15. Dorr VJ, Cook J. Agranulocytosis and near fatal sepsis due to 'Mexican aspirin' (dipyrone). South Med J 1996;89:612-614.

16. Yetgin S, Ozyurek E, Aslan D, et al. Metamizole-induced severe aplastic anemia and its recovery with s short-course steroid therapy. Metamizole sodium-induced severe aplastic anemia and its recovery with a short-course steroid therapy. 2004 Jun;21:343-347.

Santiago Garcia, MD, Mariana Canoniero, MD, Gilberto Lopes, MD, and Andres Omar Soriano, MD

From the Department of Medicine, University of Miami Leonard Miller School of Medicine, Miami, FL, and the Division of Medical Oncology, The University of Texas, MD Anderson Cancer Center, Houston, TX.

Reprint requests to Santiago Garcia, MD, 8395 NW 143rd Terrace, Miami Lakes, FL, 33016. Email: Agarcia7@med.miami.edu

Accepted May 3, 2006.

RELATED ARTICLE: Key Points

* Since metamizole was banned by the Federal Drug Administration in 1977, most US physicians are not aware of the existence of this drug and its potential complications.

* Metamizole can be found in up to one third of Latino households.

* One third of patients reported having used the drug in the last year.

* The mortality rate associated with an episode of metamizole-induced agranulocytosis ranges from 7 to 32%.

* Physicians and public health authorities must promote safer alternatives to metamizole.
Table 1. Generic and brand names under which metamizole is sold in Latin
America

Generic description Brand name Marketed indication

Metamizole or dipyrone Conmel (Sanofi Winthrop) Pain or fever
 as a single agent Dalmasin (Columbia)
 Fardolipin (Farcoral)
 Magnol (Atlantis)
 Neomelubrina (Hoechst
 Marion Rousel)
 Prodolina (Promeco)
 Uidol (Diba)
Metamizole or dipyrone Bipasmin Compuesto Relief of smooth
 plus pargeverine (Promeco) muscle pain and
 hydrochloride spasm
Metamizole or dipyrone Buscapina Compositum Relief of smooth
 plus hyoscine (Boehringer Ingelheim muscle pain and
 butylbromide Sons) spasm
 Busconet (Sons)
 Buspina (Farcoral)
 Colepren (Randall)
 Retodol Compositum (Rimsa)
Metamizole or dipyrone Dolnefort (Farcoral) Pain and neuritis
 plus vitamin B Dolo-Tiaminol (Silanes)

Reproduced with permission from Bonkowsky J, Frazer K, Buchi K, et al
Metamizole use by Latino immigrants: A common and potentially harmful
home remedy. Pediatrics 2002;109. Available at:
http://www.pediatrics.oeg/cgi/content/full/109/6/e98.

Table 2. Baseline characteristics of the study cohort

Age (mean [+ or -] SD) 54 ([+ or -]10)
Male gender 57%
Country of origin
 Cuba 47%
 Puerto Rico 10%
 Dominican Republic 10%
 Colombia 6%
 Others 27%
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Title Annotation:Original Article; includes statistical tables and related article "Key Points"
Author:Soriano, Andres Omar
Publication:Southern Medical Journal
Geographic Code:1USA
Date:Sep 1, 2006
Words:1859
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