02770nas a2200229   4500000000100000008004100001653003700042653001200079653001700091653001600108653001100124653004400135100001200179700002500191700001300216245018100229856006700410300001100477490000700488050001400495520203100509       2013                            d10aNo-observed-adverse-effect level10aleprosy10aDrug Therapy10aCombination10aBrazil10aAdverse Drug Reaction Reporting Systems1 aMaia MV1 aGraça Souza Cunha M1 aCunha CS00aAdverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil  uhttp://www.scielo.br/pdf/abd/v88n2/0365-0596-abd-88-2-0205.pdf  a205-100 v88  aMAIA 20133 aAbstract: BACKGROUND: After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and
detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control.
Hence, new alternative schemes and monitoring of adverse effects to avoid treatment abandonment are important considerations.
OBJECTIVE: Describe the side effects of a multidrug regimen containing minocycline, ofloxacin, and clofazimine in multibacillary
leprosy patients.
METHODS: We conducted a prospective, descriptive, and observational study with multibacillary patients, including cases of
intolerance to standard MDT and relapses. The study was carried out at Fundação Alfredo da Matta (Alfredo da Matta
Foundation), in Manaus, Amazonas, from April 2010 to January 2012. The patients received alternative therapy, which consisted
of daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin, and 50mg of clofazimine and a supervised
monthly dose of 300mg of clofazimine for six months, followed by eighteen months of daily doses of ofloxacin 400mg,
clofazimine 50mg, and a supervised monthly dose of clofazimine 300mg. Results: Twenty-one cases were included. Mild and
transitory side effects occurred in 33.3% of patients. Of the total episodes, 45.9% were attributed to ofloxacin and they included
abdominal pain, nausea, vomiting, headache, and insomnia; 21.6% were due to clofazimine, with 100% of patients presenting
skin pigmentation. The mean time for the development of adverse effects after beginning the therapy was 15.2 days.
CONCLUSION: All patients tolerated the drugs well, and compliance was satisfactory, with no serious events. Unlike other standard
MDT studies had shown, no treatment was stopped due to side effects. Nevertheless, patient follow-up and studies with
bigger samples are necessary to guarantee the efficacy and safety of the alternative regimen as a second-line scheme in multidrug
therapy