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Current Trends Adverse Reactions to Fansidar and Updated Recommendations for Its Use in the Prevention of Malaria

Since pyrimethamine-sulfadoxine (Fansidar) became available in the United States in 1982, it has been an integral part of the malaria prophylaxis regimen that CDC recommends for travelers at risk of exposure to chloroquine-resistant Plasmodium falciparum (CRPF). As the areas of the world with transmission of CRPF have expanded, the number of U.S. travelers using Fansidar has increased. Fansidar is usually well tolerated; however, as with other sulfonamides, severe adverse reactions associated with its use have been reported (1-5). During the past 3 months, additional cases to those reported in the literature of severe cutaneous reactions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) associated with the use of Fansidar over the past 2 years have been reported to CDC. These 10 cases (four fatal) that have occurred among U.S. travelers are currently being investigated by CDC in coordination with the U.S. Food and Drug Administration and the drug manufacturer. In addition, there is a collaborative effort under way to assess the risks associated with the use of this drug for malaria prophylaxis.

Until the risk of adverse reactions to Fansidar is more thoroughly defined, CDC recommends the following:

  1. Chloroquine remains the primary drug of choice for travelers to all malarious areas (6).

  2. When considering the use of Fansidar for chemoprophylaxis of CRPF, physicians should carefully question travelers regarding any previous history of sulfonamide intolerance. Fansidar should not be prescribed if there is any history of previous untoward reaction to sulfonamides.

  3. Travelers to CRPF regions in Asia or South America should take Fansidar in addition to chloroquine only if they stay overnight in rural areas. Travelers visiting urban areas of Asia and South America are at low risk of acquiring malaria, as are travelers to rural areas during daytime hours, because Anopheles mosquitoes bite during the evening and nighttime hours.

  4. Travelers to areas of east and central Africa where transmission of CRPF has been documented should continue to use the combination of chloroquine and Fansidar. The risk of acquiring CRPF in these areas is substantial because of the intense transmission of malaria, especially in those rural areas usually frequented by tourists.

  5. Travelers should be advised to discontinue Fansidar use immediately in the event of a possible ill effect, especially if any mucocutaneous signs or symptoms develop, such as pruritus, erythema, rash, orogenital lesions, or pharyngitis.

  6. Travelers should be informed that, regardless of the prophylactic regimen employed, it is still possible to contract malaria. Medical attention should be sought promptly in the event of a febrile illness, and the physician should be advised of the recent travel history and possibility of exposure to malaria. The above recommendations differ from earlier statements and

should be applied as the most current information available (6-8). CDC will update these interim malaria chemoprophylaxis recommendations in the near future. Additional cases of adverse reactions to Fansidar should be reported to the Malaria Branch, Division of Parasitic Diseases, Center for Infectious Diseases, CDC, telephone (404) 452-4046. Reported by Malaria Br, Div of Parasitic Diseases, Center for Infectious Diseases, Div of Quarantine, Center for Prevention Svcs, CDC.


  1. Olsen VV, Loft S, Christensen K. Serious reactions during malaria prophylaxis with pyrimethamine-sulfadoxine (Letter). Lancet 1982;II:994.

  2. Whitfield D. Presumptive fatality due to pyrimethamine-sulfadoxine (Letter). Lancet 1982;II:1272.

  3. Hornstein OP, Ruprecht KW. Fansidar-induced Stevens-Johnson syndrome (Letter). N Engl J Med 1982;307:1529-30.

  4. Ligthelm RJ, van Zwienen J, Stuiver PC, Djajadiningrat AP. Syndroom van Stevens-Johnson en granulopenie tijdens het gebruik van sulfadoxine-pyrimethamine (Fansidar). Ned Tijdschr Geneesk 1983;127:1735-7.

  5. Setia U. Fansidar-induced Stevens-Johnson syndrome and malaria prophylaxis (Letter). Pediatr Infect Dis 1983;2:173-4.

  6. CDC. Prevention of malaria in travelers 1982. MMWR 1982;31:1S-28S.

  7. CDC. Imported malaria among travelers--United States. MMWR 1984;33:388-90.

  8. CDC. Health information for international travel 1984. Atlanta, Georgia: Centers for Disease Control, 1984; HHS publication no. (CDC)84-8280;33:11-58.

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