Search

Introduction: Multidrug therapy for leprosy is currently done with dapsone, clofazimine and rifampicin. Dapsone is known to cause hemolytic anemia (HA) and this adverse event during MDT seems to be more frequent than reported. The aim of this report is to discuss and grade HA due to dapsone during MDT treatment for leprosy., Methods: This is a retrospective study of 194 leprosy patients from a Leprosy Control Programme Unit in Vit6ria-ES, Brazil., Results: HA was observed in 48 (24.7%) patients and occurred within the first 3 months in 51% of these. Mean hematocrit levels fell from 38.5 to 31.5 and hemoglobin from 12.8 to 10.3., Conclusion: Dapsone used in the MDT regime for leprosy decreases the hematocrit and hemoglobin levels due to a low grade hemolysis, which can result in significant anemia.

Objective: To assess the adverse effects of multi drug therapy (MDT) in leprosy patients., Methods: A prospective and descriptive study carried out in Department of Dermatology, Government Medical College, Jagdalpur. The adverse effects were recorded on the personal record of every individual patient, filled during the course of treatment., Results: 176 patient's records were analysed, looking for adverse effects. Among the 176 patients, 79 had adverse effects due to one or more components of MDT, 73 had adverse effects due to dapsone, eight due to rifampicin and 16 due to clofazimine. Mean (+/- SD) duration for the development of adverse effects from the start of therapy was 1.99 (+/- 0.69) months for dapsone, 36 (+/- 0.68) months for rifampicin and 7.13 (+/- 0.79) months for clofazimine. There was a significant (P < 0.05) correlation between adverse effects and low Body Mass Index (BMI). The suspected drug was stopped and an alternative regime started in nine patients; six had dapsone stopped, two had rifampicin stopped and one had clofazimine stopped., Conclusion: Adverse effects attributed to MDT are comparable to previous studies and we found that ADR due to Dapsone was very high but most of the ADR were managed by supportive treatment without replacing the suspected drug.

Introduction: Dapsone Hypersensitivity Syndrome (DHS) occurs in approximately 2% of leprosy patients in Nepal. DHS and other adverse effects of dapsone lead to withdrawal of the drug., Methods: We reviewed the notes of patients who had dapsone withdrawn from their multi-drug therapy (MDT) following an adverse reaction to the drug between 1990 and 2007., Results: 105 patients were identified from the database and 67 had a documented completion of a modified course of MDT. The majority were treated with rifampicin and clofazimine. All 36 individuals who were slit-skin smear positive had a satisfactory fall in their mean bacterial index. There were no cases of relapse., Conclusions: Rifampicin and clofazimine appear to be satisfactory treatment for both paucibacillary and multibacillary patients who have to have dapsone stopped because of severe adverse effects.

Introduction: The WHO MDT for leprosy treatment was officially introduced in Brazil in 1991 and comprises three drugs: dapsone, rifampicin and clofazimine. There are few good studies on the frequency of side-effects attributable to MDT in Brazil., Methods: A retrospective and descriptive study carried out in a LCP in Vitória, State of Espirito Santo, Brazil. A specific and detailed protocol about side-effects was prepared and filled in from the patient records., Results: One hundred ninety four patients' records were analysed looking for side-effects attributable to MDT. Side-effects were attributed to at least one MDT component in 88 (45%) patients and 85 had side-effects due to dapsone, 24 due to rifampicin and 18 due to clofazimine. 185 episodes were identified. The suspected drug was stopped in 47 out of 88 episodes (24% patients); 46 had dapsone stopped, 5 had rifampicin stopped and no-one had clofazimine stopped., Conclusion: Side-effects attributed to MDT is more frequent than previously described, resulting in interruption of treatment in many patients.

We report a case with abdominal complications of clofazimine treatment which included blackish discolouration of the lymph nodes, omentum and peritoneum. A 44-year-old female with lepromatous leprosy and a history of adverse reaction to clofazimine 2 years previously, presented with rectosigmoid junction adenocarcinoma. Laparotomy revealed an inoperable tumour with pigmentation of the bowel, serosa and peritoneum. A second operation had o be performed for transverse loop colostomy and a mesenteric lymph node biopsy sent for frozen section showed typical clofazimine crystals. Despite widespread use for many years in the treatment of leprosy, this drug is not known to be carcinogenic and this case provides no evidence for an association or link between its use and the patient's cancer. Apart from its use in leprosy, clofazimine may be used in the treatment of disseminated Mycobacterium avium-intracellulare infection, Buruli ulcer due to M. ulcerans and occasionally in other mycobacterial infections. An awareness of the rare side-effect described above may help in the clinical assessment and management of such cases, including the avoidance of unnecessary laparotomy.

Clofazimine is an important and effective constituent of multi drug therapy for leprosy. A study has been conducted to determine the distribution of clofazimine in maternal milk so that the safety of breast-feeding during maternal ingestion of the drug can be ascertained. Eight female leprosy patients (LL/BL) on clofazimine, 50 mg daily or 100 mg on alternate days for 1-18 months, (mean 5.0 +/- 1.81 months; median 3.25 months) and in the early lactating phase were studied. Blood samples and milk specimens were collected 4-6 hr after the last daily dose. Clofazimine was assayed in the milk and plasma samples by HPTLC. Mean plasma and milk clofazimine levels were 0.9 +/- 0.03 micrograms/ml and 1.33 +/- 0.09 micrograms/ml respectively. The ratio of milk to plasma drug concentration ranged from 1.0 to 1.7 with a mean of 1.48 +/- 0.08. The amount of drug ingested by the infants was 0.199 +/- 0.013 mg/kg/day which represented 22.1 +/- 1.9% of the maternal dose.

Methaemoglobinaemia and haemolytic anaemia were the principal side-effects observed in 30 leprosy patients undergoing long-term treatment with dapsone as a single drug or as part of multidrug therapy. Hepatic, pancreatic and renal evaluations showed no relevant clinical changes. Since N-acetylation is a major metabolic pathway for dapsone, slow acetylation phenotype may be a risk factor for the development of these reactions. To confirm this hypothesis we correlated acetylator phenotype and the haematological and biochemical effects induced by dapsone. No excess proportion of slow acetylators was found. We conclude that slow acetylators are not at greater risk of developing haematological side-effects of dapsone than fast acetylators.

A 66-year-old Indian male who had been treated for recurrent erythema nodosum leprosum with 300 mg of clofazimine per day for 11 months presented to hospital with a 4 week history of severe gastrointestinal upset. Soon after admission he developed several short runs of ventricular tachycardia with a morphology suggestive of torsade de pointe. The patient had a slightly low magnesium level which was corrected within 2 days; however, his rhythm disturbance persisted for 5 days despite management with intravenous lidocaine. His gastrointestinal symptoms abated 2 weeks after clofazimine was discontinued. Subsequent investigations showed that the patient had a keratopathy and myelin-type figures in his polymorphonuclear white cells similar to that seen with the cardiotoxic drugs chloroquine and amiodarone. It is postulated that clofazimine alone or in conjunction with electrolyte disturbance was responsible for the patient's cardiac arrythmia.

A total of 49 patients with paucibacillary leprosy (PB) who completed multidrug therapy (MDT) between 1985 and 1990 were analysed retrospectively for efficacy and complications; 20 (40.8%) patients had borderline-tuberculoid (BT), 13 (26.5%) had tuberculoid (TT), 1 (2.1%) had indeterminate (I) and 15 (30.0%) had pure neural (N) leprosy; 26 patients (76.5% of 34 non-neural leprosy) were skin biopsied for histological cure before MDT was stopped. Of these 26 patients, 19 had histological clearance at 6 months while the remaining 7 cleared beyond 1 year (18-36 months). The remaining 8 non-neural patients who refused rebiopsy had MDT for 6-8 months and the MDT was stopped when there was clinical clearance. Of the 15 neural (N) leprosy patients, 11 were given MDT for 6 months while the rest had 12-18 months of treatment; 1 patient with neural leprosy, who was treated for 6 months, relapsed with BT leprosy 18 months post-treatment. There were few complications among the 49 patients-4 (8.2%) patients developed reaction to dapsone, 1 (2.0%) had the dapsone syndrome, 2 (4.1%) had haemolytic anaemia and 1 (2.0%) had dapsone hepatitis; 7 (14.3%) patients had type I reaction.