VZCZCXRO8749
PP RUEHMA RUEHPA
DE RUEHUJA #0448/01 0721319
ZNR UUUUU ZZH
P 131319Z MAR 09
FM AMEMBASSY ABUJA
TO RUEHC/SECSTATE WASHDC PRIORITY 5508
INFO RUEHOS/AMCONSUL LAGOS PRIORITY 0967
RUEHGB/AMEMBASSY BAGHDAD 0105
RUEHZK/ECOWAS COLLECTIVE
RUEHPH/CDC ATLANTA GA
RUEAUSA/DEPT OF HHS WASHDC
RUCPDOC/DEPT OF COMMERCE WASHDC
RUEAWJA/DEPT OF JUSTICE WASHDC

UNCLAS SECTION 01 OF 03 ABUJA 000448 
 
SENSITIVE 
SIPDIS 
 
DEPARTMENT FOR OES/IHA WILUSZ AND PASS TO USTR FOR AGAMA;   PTO FOR 
HICKEY; LOC FOR USCO PPINHA 
USAID FOR GH; AFR/SD; AND AFR/WA 
BAGHDAD FOR DUNDAS MCCULLOUGH 
CDC FOR NCIRD/GID/DEEB ERBER 
DHHS/OGHA FOR ADENIYI JONES 
DHHS/CDC/COGH FOR BLOUNT 
DHHS/CDC/NCHHSTP/GAP FOR BIRX 
DHHS/CDC/NCEH FOR LEWIS 
DHHS/FDA FOR ALCOCK 
DOJ FOR MKOUAME 
USDOC FOR 3317/ITA/OA/KBURRESS AND 3130/USFC/OIO/ANESA/MCREED 
 
E.O. 12958: N/A 
TAGS: TBIO EAID KIPR ECON SOCI ETRD NI
SUBJECT:  NIGERIA:  USG-GON RAPID RESPONSE STEMS ACUTE RENAL FAILURE 
OUTBREAK 
 
SENSITIVE BUT UNCLASSIFIED - DO NOT DISTRIBUTE OUTSIDE USG. 
 
¶1. (SBU):  SUMMARY:  Following reports of an unusually high number 
of cases of acute renal failure (ARF) among Nigerian children 
between November 2008 and January 2009, the USG dispatched a team of 
experts which assisted with conducting epidemiological 
investigations, developing and launching an effective public health 
media campaign, and inspecting a local manufacturer of a 
contaminated teething mixture sold as "MY PIKIN."  USG and Nigerian 
experts concluded that the ingestion of "MY PIKIN" contaminated with 
diethylene glycol was the main cause of the outbreak.  A total of 
111 children aged six to forty eight months were diagnosed with ARF 
and eighty-four died.  Mortality and morbidity from the diethylene 
glycol poisoning is likely to be under-estimated given poor 
surveillance and reporting practices.  Nigerian government 
authorities closed the Lagos-based "MY-PIKIN" manufacturing plant in 
November 2008 and on February 12 arrested twelve individuals 
suspected to be associated with the manufacturing and distribution 
of the tainted product.  Strong cooperation and excellent ties 
between the USG and GON were instrumental in positively determining 
the ARF outbreak, identifying possible risk factors, in back tracing 
the source and distribution network of the tainted teething mixture, 
and in launching effective intervention strategies to stymie the 
outbreak.  END SUMMARY. 
 
ARF OUTBREAK 
------------ 
 
¶2. (U) In mid November 2008, the Nigerian Federal Ministry of Health 
(FMOH) received a report involving 13 pediatric cases of ARF in the 
preceding three weeks from a hospital in Lagos.  These children were 
under the age of four and initially displayed nonspecific febrile 
illness, which progressed rapidly to ARF.  In subsequent weeks the 
ministry received similar reports from Kaduna, Oyo and Osun states. 
(Note:  ARF is a sudden deterioration of renal function resulting in 
the inability to maintain fluid and electrolyte balance and is 
difficult to determine its primary cause without an epidemiological 
investigation.  It is rare in children and generally reversible, if 
discovered early.  End Note). 
 
SWIFT AND COORDINATED REACTION 
------------------------------ 
 
¶3. (U) Following reports of several ARF cases, the Nigeria National 
Agency For Food and Drug Administration (NAFDAC) conducted 
preliminary product investigation and identified the 
locally-manufactured teething product "MY PIKIN" as the contaminated 
product causing the outbreak.  On November 21, NAFDAC closed the "MY 
PIKIN" manufacturing plant, launched a product recall, and issued a 
press releases warning the public about the contaminated "MY PIKIN." 
 NAFDAC also briefed both chambers of parliament on the ARF outbreak 
and actions being taken to combat it.  In response to a request from 
the FMOH, the U.S. in-country Center for Disease Control and 
Prevention (CDC) facilitated a preliminary hospital record review 
and conducted site visits of pediatric ARF cases in Kaduna, Lagos, 
Oyo and Osun states.  The review was conducted by residents of the 
U.S.-funded Field Epidemiology and Laboratory Training Program 
(FELTP).  (Note:  the FELTP trains young and upcoming Nigerian 
epidemiologists to conduct field investigations of disease outbreaks 
and toxic contaminations.  End Note). 
 
¶4. (U) The FELTP preliminary record review provided an estimate of 
the morbidity and mortality associated with the contamination. 
Laboratory analysis of samples of "MY PIKIN" indicated varying 
levels of diethylene glycol (DEG) contamination (up to 90%).  (Note: 
DEG is an odorless, colorless, and sweet testing compound used in 
industrial solvents and antifreeze.  End Note).  According to CDC 
experts, to date, there have been nine ARF outbreaks associated with 
DEG contamination worldwide.  The first outbreak was in the United 
States in 1937, which caused 105 deaths from contaminated 
sulfanilamide elixir.  Nigeria experienced an ARF outbreak in 1990, 
 
ABUJA 00000448  002 OF 003 
 
 
associated with contaminated acetaminophen, which resulted in 47 
deaths. 
 
U.S. DISPATCHES EXPERTS TO ASSIST WITH OUTBREAK 
--------------------------------------------- -- 
 
¶5. (U) A USG investigation team arrived in mid January 2009 and over 
a period of three weeks performed epidemiological investigations and 
analysis, conducted site visits and case-family interviews, and 
collected and tested medications found in case-family homes.  The 
team investigated a total of 112 cases, 57 of which were confirmed 
as having developed ARF consistent with poisoning.  Of the 57 
positive cases, 55 were determined to have been exposed to the 
contaminated "MY PIKIN."  The team also developed and put in place 
an enhanced surveillance system for further monitoring and reporting 
of ARF cases. 
 
¶6.  (U) A CDC expert in communication planning, a member of the USG 
response team, worked with a Nigerian interagency panel of 
communication experts to develop and launch an effective public 
health communication plan.  The plan included a media campaign, 
which provided accurate and timely information about the 
contaminated product and available medical assistance to the general 
public. 
 
¶7. (U) A U.S. Federal Food and Drug Administration (FDA) Product 
Inspector, another member of the USG response team, worked closely 
with Federal and Lagos Region NAFDAC officials and revamped NAFDAC 
operational standards for incidents of this kind, including a 
standardized checklist for site inspections of manufacturing 
facilities.  A site visit of the "MY PIKIN" manufacturer, Barewa 
Pharmaceuticals Ltd was conducted in Lagos.  It was determined that 
the manufacturer's poor recordkeeping practices hindered efforts to 
identify and stop further distribution of contaminated lots of "MY 
PIKIN." 
 
USG TEAM CONCLUSION AND RECOMMENDATIONS 
--------------------------------------- 
 
¶8. (U) Investigation of the majority of reported cases of ARF 
confirmed exposure to "MY PIKIN," even though inferences of 
causation are complicated by the presence of multiple drug 
exposures.  Potentially life-threatening DEG-induced toxicity 
continues to be a public health problem due to residual "MY PIKIN" 
remaining in households, in some health facilities, and in market 
circulation by itinerant and unscrupulous drug vendors.  The USG 
team provided the following recommendations to the GON before its 
departure: 
 
-- Further public health campaign be conducted to heighten awareness 
of the dangers of contaminated "MY PIKIN." 
 
-- Guidance to parents, physicians and pharmacists on how to forfeit 
leftover "MY PIKIN" medications be issued. 
 
-- Create a mechanism to track surrendered medications to fully 
account for contaminated batches and their raw ingredients. 
 
-- Targeted education campaign for parents on appropriate treatments 
for teething and the dangers of using poly-pharmacy be conducted. 
 
-- Heightened ARF surveillance should continue until the drug recall 
efforts can reasonably account for and recover the preponderance of 
medication manufactured. 
 
¶9. (SBU) COMMENT:  The GON's swift reaction and USG's critical 
technical assistance has mitigated the impact of an ARF outbreak in 
Nigeria.  The U.S. Mission will monitor the situation closely and 
follow the implementation of the recommendations.  Nigeria lacks a 
safe drug manufacturing, procurement and distribution system, which 
has lead to substandard pharmaceutical products and the flourishing 
 
ABUJA 00000448  003 OF 003 
 
 
of illegal markets for fake and counterfeit drugs.  The problem is 
compounded by a weak and overburdened public health system that is 
incapable of effectively responding to drug-induced or other types 
of outbreaks.  The USG-funded Field Epidemiology and Laboratory 
Training Program (FELTP), which started training Nigeria 
epidemiologists in 2007, is enhancing Nigeria's ability to better 
respond to public health emergencies.  END COMMENT. 
 
¶10. (U) This cable was coordinated with Consulate Lagos. 
 
SANDERS