PMID- 22315391
OWN - NLM
STAT- MEDLINE
DCOM- 20120322
LR  - 20131121
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Linking)
VI  - 205 Suppl 1
DP  - 2012 Mar
TI  - Pharmacovigilance of malaria intermittent preventive treatment in infants coupled 
      with routine immunizations in 6 African countries.
PG  - S82-90
LID - 10.1093/infdis/jir799 [doi]
AB  - BACKGROUND: Intermittent preventive treatment in infants (IPTi) is a new malaria 
      control strategy coupled with the delivery of routine immunizations recommended 
      by the World Health Organization since 2009 for countries with moderate to high 
      endemicity. To evaluate its safety profile and identify potential new adverse 
      events (AEs) following simultaneous administration of sulfadoxine-pyrimethamine 
      (SP-IPTi) with immunizations, we measured AE incidence and evaluated spontaneous 
      AE reporting. METHODS: A cohort event monitoring study was conducted on 24 000 
      infants in 2 countries after administration of SP-IPTi during routine 
      immunizations. Additional pharmacovigilance training and supervision were 
      conducted to stimulate AE passive reporting in 6 African countries. RESULTS: No 
      serious AEs were found by active follow-up, representing 95% probability that the 
      rate does not exceed 1 per 8000. No serious AEs were found by retrospective 
      review of hospital registers. The rate of moderate AEs probably linked to 
      immunization and/or SP-IPTi was 1.8 per 1000 doses (95% confidence interval, 
      1.50-2.00). Spontaneous reporting of AEs remained <1% of cases collected by 
      active follow-up. CONCLUSIONS: Simultaneous administration of SP-IPTi and 
      immunizations is a safe strategy for implementation with a low risk of serious 
      AEs to infants. Strategies toward strengthening spontaneous reporting in Africa 
      should include not only the provider but also beneficiaries or their caregivers.
FAU - de Sousa, Alexandra
AU  - de Sousa A
AD  - UNICEF New York, USA. alexandra.desousa@verizon.net
FAU - Rabarijaona, Leon Paul
AU  - Rabarijaona LP
FAU - Tenkorang, Ofori
AU  - Tenkorang O
FAU - Inkoom, Ebenezer
AU  - Inkoom E
FAU - Ravelomanantena, Hantamalala V
AU  - Ravelomanantena HV
FAU - Njarasoa, Sabrina
AU  - Njarasoa S
FAU - Whang, Jeremiah Nee
AU  - Whang JN
FAU - Ndiaye, Jean Louis
AU  - Ndiaye JL
FAU - Ndiaye, Youssoupha
AU  - Ndiaye Y
FAU - Ndiaye, Mouhamed
AU  - Ndiaye M
FAU - Sow, Doudou
AU  - Sow D
FAU - Akadiri, Guinoussa
AU  - Akadiri G
FAU - Hassan, Jacques
AU  - Hassan J
FAU - Dicko, Alassane
AU  - Dicko A
FAU - Sagara, Issaka
AU  - Sagara I
FAU - Kubalalika, Prestor
AU  - Kubalalika P
FAU - Mathanga, Don
AU  - Mathanga D
FAU - Bizuneh, Ketema
AU  - Bizuneh K
FAU - Randriasamimanana, Jean Rene
AU  - Randriasamimanana JR
FAU - Recht, Judith
AU  - Recht J
FAU - Bjelic, Ivana
AU  - Bjelic I
FAU - Dodoo, Alexander
AU  - Dodoo A
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Antimalarials)
RN  - 0 (Drug Combinations)
RN  - 0 (Malaria Vaccines)
RN  - 37338-39-9 (fanasil, pyrimethamine drug combination)
RN  - 88463U4SM5 (Sulfadoxine)
RN  - Z3614QOX8W (Pyrimethamine)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Africa
MH  - Antimalarials/*adverse effects
MH  - Drug Combinations
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Humans
MH  - *Immunization
MH  - Infant
MH  - Malaria/*prevention & control
MH  - Malaria Vaccines/*adverse effects
MH  - Male
MH  - *Pharmacovigilance
MH  - Pyrimethamine/*adverse effects
MH  - Sulfadoxine/*adverse effects
EDAT- 2012/02/15 06:00
MHDA- 2012/03/23 06:00
CRDT- 2012/02/09 06:00
PHST- 2012/02/09 06:00 [entrez]
PHST- 2012/02/15 06:00 [pubmed]
PHST- 2012/03/23 06:00 [medline]
AID - jir799 [pii]
AID - 10.1093/infdis/jir799 [doi]
PST - ppublish
SO  - J Infect Dis. 2012 Mar;205 Suppl 1:S82-90. doi: 10.1093/infdis/jir799.