PMID- 26951203
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20220801
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 36
IP  - 5
DP  - 2016 May
TI  - Safety Profile of Artemether-Lumefantrine: A Cohort Event Monitoring Study in 
      Public Health Facilities in Tanzania.
PG  - 401-11
LID - 10.1007/s40261-016-0385-z [doi]
AB  - BACKGROUND AND OBJECTIVE: Artemisinin combination therapies such as 
      artemether-lumefantrine (AL) are effective for first-line treatment of 
      uncomplicated acute Plasmodium falciparum malaria. However, the safety profile of 
      AL in large populations has not been fully assessed. The objective of this study 
      was to establish the safety of AL in public health facilities in Tanzania using 
      the Cohort Event Monitoring (CEM) method. METHODOLOGY: Patients who presented to 
      public health facilities in four regions of Tanzania who were prescribed AL were 
      enrolled in a CEM study, a prospective, observational cohort study to establish a 
      profile of adverse events (AEs) for the medicine when used in routine clinical 
      practice. Pre- and post-treatment forms were used to record baseline information 
      and new health events before and 7 days after treatment. RESULTS: A total of 8040 
      patients were enrolled in the study, of whom 6147 were included in the analysis. 
      Following treatment initiation, a total of 530 AEs were reported in 6% (383) of 
      the patients. The most frequent post-treatment AEs were in alimentary system 
      (42%), including vomiting, nausea, diarrhoea, abdominal pain and anorexia, 
      followed by AEs in the neurological system (25%). Causality assessment of the 
      events showed that 51.9% (275/530) were possibly related to AL. There was a 
      significant difference in the frequency of AEs by age-group with an increase in 
      the number of AEs as age increased (P < 0.001). There was no statistically 
      significant difference in the frequency of the events between males and females 
      (P = 0.504). The AE profile was consistent with the AEs reported in the product 
      information and in other studies; no new adverse drug reactions were identified. 
      The majority of the reported AEs were the same as the symptoms of malaria and 
      therefore indistinguishable from the underlying disease. CONCLUSIONS: The safety 
      profile of AL for treatment of malaria continues to be favourable. CEM as a 
      pharmacovigilance tool has proven to provide reliable safety data in a short 
      period.
FAU - Mssusa, Alambo K
AU  - Mssusa AK
AD  - Department of Clinical Trials Control and Pharmacovigilance, Tanzania Food and 
      Drugs Authority, P.O. Box 77150, Dar Es Salaam, Tanzania. alambopharm@yahoo.com.
FAU - Fimbo, Adam M
AU  - Fimbo AM
AD  - Directorate of Medicines and Complementary Products, Tanzania Food and Drugs 
      Authority, P.O. Box 77150, Dar Es Salaam, Tanzania.
FAU - Nkayamba, Alex F
AU  - Nkayamba AF
AD  - Department of Clinical Trials Control and Pharmacovigilance, Tanzania Food and 
      Drugs Authority, P.O. Box 77150, Dar Es Salaam, Tanzania.
FAU - Irunde, Henry F
AU  - Irunde HF
AD  - Pharmaceutical Services Unit, Ministry of Health and Social Welfare, P.O. Box 
      9083, Dar Es Salaam, Tanzania.
FAU - Sillo, Hiiti B
AU  - Sillo HB
AD  - Directorate of Medicines and Complementary Products, Tanzania Food and Drugs 
      Authority, P.O. Box 77150, Dar Es Salaam, Tanzania.
FAU - Shewiyo, Danstan H
AU  - Shewiyo DH
AD  - Directorate of Laboratory Services, Tanzania Food and Drugs Authority, P.O. Box 
      77150, Dar Es Salaam, Tanzania.
FAU - Hill, Geraldine
AU  - Hill G
AD  - Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug 
      Monitoring, Box 1051, 75140, Uppsala, Sweden.
FAU - Minzi, Omary M
AU  - Minzi OM
AD  - Unit of Pharmacology and Therapeutics, School of Pharmacy, Muhimbili University 
      of Health and Allied Sciences, P.O. Box 65013, Dar Es Salaam, Tanzania.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Antimalarials)
RN  - 0 (Artemether, Lumefantrine Drug Combination)
RN  - 0 (Artemisinins)
RN  - 0 (Drug Combinations)
RN  - 0 (Ethanolamines)
RN  - 0 (Fluorenes)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antimalarials/*administration & dosage/*adverse effects
MH  - Artemether, Lumefantrine Drug Combination
MH  - Artemisinins/*administration & dosage/*adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Cohort Studies
MH  - Drug Combinations
MH  - Drug Monitoring/*methods/trends
MH  - Drug-Related Side Effects and Adverse Reactions/diagnosis/epidemiology
MH  - Ethanolamines/*administration & dosage/*adverse effects
MH  - Female
MH  - Fluorenes/*administration & dosage/*adverse effects
MH  - Health Facilities/trends
MH  - Humans
MH  - Infant
MH  - Malaria/*drug therapy/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Prospective Studies
MH  - Tanzania/epidemiology
MH  - Vomiting/chemically induced
MH  - Young Adult
EDAT- 2016/03/10 06:00
MHDA- 2016/12/15 06:00
CRDT- 2016/03/09 06:00
PHST- 2016/03/09 06:00 [entrez]
PHST- 2016/03/10 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
AID - 10.1007/s40261-016-0385-z [pii]
AID - 10.1007/s40261-016-0385-z [doi]
PST - ppublish
SO  - Clin Drug Investig. 2016 May;36(5):401-11. doi: 10.1007/s40261-016-0385-z.