Gambia - Government investigates as children die of mysterious disease - WHO issues a medical product alert for four contaminated medicines

[Pathfinder]

GOV’T INVESTIGATES AS CHILDREN DIE OF MYSTERIOUS DISEASE

AUGUST 4, 2022

By Lamin Cham

The Epidemiology and Disease Control Unit of the Ministry of Health and the Edward Francis Small Teaching Hospital have launched an investigation into the sudden emergence of a mysterious sickness affecting mainly small children from many parts of the country.

According to reliable medical sources, in the past few weeks and days, several children were received at various health centres with symptoms of diarrhoea and vomiting and in several cases inability to urinate due to kidney malfunction.

Our source further revealed that almost fifty percent of those affected have died. According to our source, cases have been reported from different areas of the country prompting the authorities to start an urgent investigation into the problem.
...
https://standard.gm/gambia-news/govt-investigates-as-children-die-of-mysterious-disease/

 

[Pathfinder]

WEEKLY BULLETIN ON OUTBREAKS
AND OTHER EMERGENCIES

Week 33: 8 - 14 August 2022
Data as reported by: 17:00; 14 August 2022
...
All events currently being monitored by WHO AFRO
...
Gambia Undiagnosed disease (acute renal failure) Ungraded

Date notified to WCO 11-Aug-22
Start of reporting period 4-Jul-22
End of reporting period 4-Aug-22

Total cases 19
Cases Confirmed
Deaths 17
CFR 89,50%

On 1 August 2022, the Epidemic and Disease Control Unit of the Ministry of Health in Gambia reported an unusual event detected at the Edward Francis Small Teaching Hospital, the main tertiary hospital in the country. Nineteen cases with 17 deaths have been reported. The median age is 17 years old and range from five to 46 months.
The index case was traced to 4 July. Patients presented with symptoms such as inability to urinate (100% of cases), fever (100% of cases), vomiting (91%), and diarrhoea (55%). All children had an acute onset of symptoms, and clinical progression was rapid. Preliminary investigation was conducted to identify contacts of the cases. No similar illness among other siblings of similar age or other household members was detected. Further investigation is ongoing.

https://apps.who.int/iris/bitstream/handle/10665/361771/OEW33-0814082022.pdf

 

[Pathfinder]

September 8, 2022
10:32 AM CST
Last Updated a day ago

Gambia probes link between dozens of child deaths and paracetamol syrup

By Edward Mcallister and Pap Saine

BANJUL, Sept 8 (Reuters) - ...
...
Gambia's director of health services, Mustapha Bittaye, told Reuters that a number of patients began to fall ill with kidney problems three to five days after taking a paracetamol syrup sold locally. It was not yet clear if any particular brand of paracetamol, used by parents in many countries to treat fevers in children, was under investigation.

E. coli bacteria was also a possible cause, Bittaye said.
...
By early August, 28 children had died, according to health ministry figures, with a fatality rate of nearly 90%. The number of fatalities is now much higher, said Bittaye.
....

https://www.reuters.com/world/africa...ol-2022-09-08/



-------------------------------------------------
Lamin Jahateh@LmnJahateh

 

[Mary Wilson]

West Africa - Gambia Halts Syrup Paracetamol Use After Child Deaths

September 9, 2022

By AFP - Agence France Presse

The Gambia's Health Ministry has asked hospitals to stop using syrup paracetamol after at least 28 children died of kidney failure.

"We have clinical evidence to suspect syrup paracetamol may be one of the culprits," Mustapha Bittaye, the director of health services, told AFP Friday.

"We are advising our staff on the medicines to give while awaiting the conclusion of the investigation", the director added.

... country's regional health directors, hospital chief executives, and clinics this week, Bittaye cited E. coli as another possible cause ...

https://www.barrons.com/news/gambia...ol-use-after-child-deaths-01662746707?tesla=y

 

[Mary Wilson]

Gambia probes link between dozens of child deaths and paracetamol syrup

09 September 2022 - 09:39
BY EDWARD MCALLISTER AND PAP SAINE

... A spike in cases of acute kidney injury among children under the age of five was detected in late July. As cases mounted, doctors began to suspect medicines could be involved.

Gambia's director of health services, Mustapha Bittaye, told Reuters that a number of patients began to fall ill with kidney problems three to five days after taking a paracetamol syrup sold locally. It was not yet clear if any particular brand of paracetamol, used by parents in many countries to treat fevers in children, was under investigation.

... By early August, 28 children had died, according to health ministry figures, with a fatality rate of nearly 90%. The number of fatalities is now much higher, said Bittaye.

An official updated tally is expected in the coming days.

"Dozens of children have died in the last three months," Bittaye told Reuters by phone. "Autopsies suggest the possibility of paracetamol."

'QUITE UNUSUAL'

World Health Organisation officials said the evidence points not to paracetomol but to an infectious origin such as polluted water, though there are many unanswered questions.

"It is quite unusual because it is confined to only one age group. Normally you see different age groups affected. That is why we are trying to investigate everything," said Sharmila Lareef-Jah, a disease prevention specialist at the WHO in Gambia.

Samples of the drugs that the children took have been sent to toxicology labs in Senegal and Ghana for testing. Results are expected early next week, Lareef-Jah said.

https://www.timeslive.co.za/news/af...dozens-of-child-deaths-and-paracetamol-syrup/

 

[Pathfinder]

Translation Google

In The Gambia, the mysterious deaths of dozens of children with acute kidney failure

The authorities have opened an investigation to try to explain this phenomenon, citing flooding and taking paracetamol in syrup as possible causes.

Le Monde with AFP
Posted today at 10:04 a.m.

US experts are expected in The Gambia in the coming days to assist health services after the mysterious deaths of dozens of children with acute kidney failure. A sudden increase in cases among children aged 5 months to 4 years has led to the death of at least 28 of them, says a report from the Ministry of Health dated August 8.

Authorities have opened an investigation and cited E. coli bacteria and taking syrup containing paracetamol as possible causes. The ministry again evokes one and the other as possible suspects in a press release received on Sunday, September 11 by an AFP correspondent. It covers the floods that have hit this tropical country in recent weeks in the middle of the rainy season.

"The Gambia has experienced the heaviest rains in its recent history ," the ministry said. The rains overflowed sewers and latrines, spilled faeces into stagnant water and contaminated many water points. “The number of cases of severe kidney disease has increased since July 2022 with a high mortality rate among children, mainly after the occurrence of diarrhoea ,” the ministry said.

Hygiene instructions

E. coli bacteria were detected in the stools of many children, but many had also taken paracetamol syrup, the ministry said. But “paracetamol in syrup has caused kidney disease in some countries,” he says. “We are therefore suspending the use of paracetamol in syrup throughout the country, while the necessary examinations are carried out ,” adds the ministry.

The various health services cooperate with the World Health Organization (WHO) and Unicef. And experts from the Centers for Disease Control and Prevention, the lead US federal public health protection agency, are expected in the coming days, the department says. This one calls the public to strict hygiene and frequent hand washing. He asks parents not to leave children in contact with stagnant water. He recommends boiling water intended for consumption and thoroughly washing fruits and vegetables.

The Gambia, the smallest country in mainland Africa with just over 2 million inhabitants, is 174th out of 191 according to the UN's human development index, which aggregates criteria of health, education and quality of life. Nearly half of the population there lives below the poverty line, according to the World Bank.

https://www.lemonde.fr/afrique/arti...d-insuffisance-renale-aigue_6141220_3212.html

 

[Pathfinder]

WEEKLY BULLETIN ON OUTBREAKS
AND OTHER EMERGENCIES

Week 39: 19 - 25 September 2022
Data as reported by: 17:00; 25 September 2022
...

Acute kidney injury secondary to Escherichia Coli infection Gambia

75 cases
50 Deaths
66.7% CFR

EVENT DESCRIPTION

On 1 August 2022, the Epidemic and Disease Control Unit of
the Ministry of Health in the Gambia reported an unusual event
detected at a Teaching Hospital. A nephrologist at that hospital
reported an unusual increased incidence of acute kidney injury
(AKI) of unknown aetiology. A case definition was developed
following which a retrospective analysis of hospital records was
conducted to 19 June 2022. This revealed additional cases, with
the index case traced to 4 July 2022.

As of 23 September 2022, at least 75 cases have been reported
among young children aged one month to seven years from six
of the seven health regions in the country: Western Region 1 (32
cases) and 2 (19 cases) (WR 1&2), Upper River Region (URR)
(13 cases), Lower River Region (LRR) (1 case), North Bank West
Region (NBWR) (1 case), and Central River Region (CRR) (4
cases). The remaining five cases are being classified. Most of the
cases (86%) are from three health regions (WR 1&2 and URR),
and over 80% were less than two years old. A total of 50 deaths
have been reported, resulting in a case fatality ratio of 66.7%.

The clinical features among the cases include fever followed
by anuria (in 81% of cases), vomiting (61%), diarrhoea (51%)
and cough (10%). The average duration of illness was nine days
(range 5-18 days). A laboratory test confirmed AKI in 40% of
children who had a kidney function test. In addition, of those who
had a complete blood count (40%) test done, the white blood
cell counts (predominantly granulocytes) was elevated in 60% of
cases, but normal in 40% of cases. and routine urine tests were
normal (dip stick and microscopy).

Stool samples from children with similar clinical symptoms
to AKI cases (fever, vomiting and diarrhoea) were negative for
rotavirus and Vibrio cholerae. However, 38 (61%) out of 62
stool samples (from children with similar clinical presentation
as AKI cases) tested positive for Escherichia Coli (E. coli.). Two
samples were positive for Shiga toxin- producing E. coli (O157).
Whole-genome sequencing of E. coli to identify lineage was also
done and is awaiting interpretation. Water quality assessment
tests conducted in household of children with AKI revealed the
presence of E. coli, but were negative for heavy metals including
mercury and lead. Additionally, increased nitrite levels mainly
in boreholes and one major national water source (Fajara) were
also reported. The 2018 Multiple Indicator Cluster Surveys also
revealed the presence of E. coli in all the water points tested.

Most of the children had received treatment before presenting
at the referral hospital. The most common medicine was an
antipyretic (40%), followed by antihistamine/antiemetic (7%) and
cough syrup (6%). Nine samples of medicines taken by the children
with AKI were sent for toxicological analysis. Results revealed
that two out of nine medicine samples (one brand of paracetamol
and one brand of promethazine) contained ethylene glycol, and
diethylene glycol plus ethylene glycol, respectively. Post-mortem
findings from two cases of AKI revealed findings consistent with
malnutrition and renal injury with no pathognomonic signs that
could be linked to a specific cause.

PUBLIC HEALTH ACTIONS

A case definition was developed by the Ministry of health
with support from the WHO for case detection and the
retrospective analysis of hospital records. The case definition
allowed more case detection and the communication to all
the regions on the event across the country

Laboratory investigation for samples (stool, bloods,
urine) collected from cases and toxicology assessment of
medicines taken were conducted

Measures to prevent food- and water-borne infections have
been disseminated

Supporting the capacity of Medicine Control Agency to
ensure effective regulatory oversight on medicines in the
country including market surveillance and control and
access to quality control laboratory is ongoing

The planning of an in-depth epidemiological investigation
to gather additional information to confirm the etiology and
assess potential contributing factors for the good definition
of prevention and control measures is ongoing.

SITUATION INTERPRETATION

Acute kidney injury in children particularly in developing countries
is associated with high mortality rates. Most countries including
the Gambia do not have proper and adequate human and material
resources to manage kidney disease requiring dialysis. This
is the first time an acute kidney injury outbreak is reported in
The Gambia. There is therefore an urgent need to identify the
definitive causative agent, so that adequate measures can be put
into place to prevent further cases as well as clinical progression
of cases to acute kidney injury.

https://extranet.who.int/iris/restricted/bitstream/handle/10665/363303/OEW39-1925092022.pdf

 

[Pathfinder]

WHO Director-General's opening remarks at the media briefing – 5 October 2022

5 October 2022
...
Finally, WHO has today issued a medical product alert for four contaminated medicines identified in The Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children.

The loss of these young lives is beyond heartbreaking for their families.

The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India.

WHO is conducting further investigation with the company and regulatory authorities in India.

While the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries.

WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients.

https://www.who.int/news-room/speec...-remarks-at-the-media-briefing-5-october-2022

--------------------------------------------

Medical Product Alert N°6/2022: Substandard (contaminated) paediatric medicines

Substandard (contaminated) paediatric medicines identified in WHO region of Africa

5 October 2022
Medical product alert

Geneva

Reading time: 2 min (455 words)
FrançaisAlert Summary


This WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to WHO in September 2022. Substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore "out of specification"[1].

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.

Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.

[1] WHO definitions: https://www.who.int/teams/regulation...nd/definitions


Risks


Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal

Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities.

The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.

Advice to regulatory authorities and the public

It is important to detect and remove these substandard products from circulation to prevent harm to patients.

WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised.

All medical products must be approved and obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional when in doubt.

If you have these substandard products, please DO NOT use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre.

National regulatory/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country. If you have any information concerning the manufacture or supply of these products, please contact WHO via rapidalert@who.int

Please click here for details and photos of the substandard products referenced in Alert N°6/2022.

Alert n°6/2022 may be updated at a later stage as and when necessary.





WHO Global Surveillance and Monitoring System

for Substandard and Falsified Medical Products

For more information, please visit our website

Email: rapidalert@who.int

https://www.who.int/news/item/05-10-...tric-medicines

 

[Pathfinder]

India Tests Samples of Cough Syrup Linked to Deaths of Children in Gambia

By Reuters
Oct. 5, 2022, at 11:01 p.m.
By Krishna N. Das

NEW DELHI (Reuters) -India is testing samples of cough syrups produced by Maiden Pharmaceuticals for exports after the World Health Organization said its products were linked to the deaths of dozens of children in Gambia, the country's health ministry said on Thursday.
...
India's health ministry said samples of the same batch manufactured by Maiden for all four drugs has been sent for testing to a federal laboratory and the results would "guide further course of action as well as bring clarity on the inputs received/to be received from WHO."

It asked the WHO to share its report on "establishment of causal relation to death with the medical products in question."

The WHO did not immediately respond to an emailed request for comment.

Anil Vij, the health minister of Haryana state where Maiden has its factories, warned of "strict action if anything is found wrong" after the tests.

Naresh Kumar Goyal, a Maiden director, told Reuters that it heard about the deaths only on Thursday morning and were trying to find out details.

"We are trying to find out the situation because it cropped up only today," he said by phone. "We are trying to find out with the buyer and all that what has happened exactly. We are not selling anything in India." He declined to speak further.
...
Maiden, which launched its operations in November 1990, manufactured and exported the syrup only to Gambia, the Indian health ministry said. Maiden on its website says it has two manufacturing plants, in Kundli and Panipat, both near New Delhi in Haryana, and has recently set up another one.
...
https://money.usnews.com/investing/...mbia-linked-to-india-made-cough-syrup-sources

------------------------------

Gambia recalls Indian-made cough syrup linked to deaths of 66 children

DCGA initiates probe, Haryana sends cough syrup samples to Calcutta lab

Published 06.10.22, 06:53 PM

Gambia has launched a door-to-door campaign to collect cough and cold syrups blamed for the deaths of more than 60 children from kidney injury in the tiny West African country, reports said on Thursday, reports ndtv.com

India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
...
Haryana's Health Minister Anil Vij on Thursday said samples of four cough syrups manufactured by the firm have been sent to the Central Drugs Laboratory in Kolkata for examination.
...
Vij said the cough syrups manufactured by the pharma company were approved for export. "It is not available for sale or marketing in the country."

"Whatever action has to be taken will be taken once the CDL report comes. Only after the report is in, we can arrive at any conclusion," Vij said.
...
According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to Gambia.

It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.

The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority.
..
According to tentative results received by WHO out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated. It has also been informed by WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India.
...
https://www.telegraphindia.com/worl...p-linked-to-deaths-of-66-children/cid/1890484

 

[Pathfinder]

The Gambia Police Force
3d ·

STATEMENT: PRELIMINARY POLlCE INVESTIGATION REPORT INTO THE DEATH OF 66 CHILDREN IN THE GAMBIA.

Following the outbreak of Acute Kidney Injury which claimed the lives of at least 66 children in The Gambia, The Office of the Inspector General of Police, through its Crime Management Coordination Unit, opened a swift probe into the incident and discovered the following information.

It was established that Atlantic Pharmaceuticals Company was granted permission to import medicines and medical-related products in The Gambia.

That the release of these medical products to the retailers/final consumers was immediately followed by an Acute Kidney Injury (AKI) outbreak in the Gambia resulting in the death of at least 66 children.

The circumstances of the deaths prompted the Ministry of Health and its stakeholders to investigate the cause(s) of death.

Investigations so far revealed that Atlantic Pharmaceuticals Company Limited ordered a quantity of 15, 000 bottles of makoff baby cough syrups of 100ml, 15, 000 bottles of magrip and cold syrups of 100ml, 10, 000 bottles of promethazine baby syrups of 100ml and 10, 000 kofexmalin baby cough syrups of 125ml. Thus, amounting to a combined total of 50, 000 bottles of contaminated baby syrups.

The deaths of these children are associated with four contaminated Indian-made baby syrups bearing the names Lakoff baby cough, maghrib, and cold, promethazine syrup, and kofexmalin baby cough syrups imported in the Gambia by Atlantic Pharmaceuticals Company Limited.

It is established that from the aforesaid sum of 50, 000 bottles of contaminated baby syrups, 41, 462 bottles have been quarantined/seized by MCA, and 8, 538 bottles remained unaccounted for.

In addition to these important revelations, our investigation team has also identified pending issues to be clarified with required evidential material and justifications.

While the investigation into this matter continues, the general public is once again urged to remain calm in this difficult situation.

https://www.facebook.com/people/The-Gambia-Police-Force/100070031176300/

 

[Emily]

Could a US company really be involved in this horrible injury of children? The company in Atlanta is an 'Inc', not an 'Ltd'. They seem to specialize in pain control and addiction, not cough medicine for children. DNB has a listing for a 'Ltd', but I can't access. There is an 'Ltd' in Thailand, though.

https://www.cnbctv18.com/world/maid...-scandal-what-happened-in-gambia-14940391.htm
By CNBCTV18.com Oct 13, 2022, 06:56 PM IST (Published)
...
United States-based Atlantic Pharmaceuticals Company Ltd ordered 50,000 bottles of these cough syrups for export to Gambia, the police report said.

https://www.thestatesman.com/india/...ims-on-maiden-pharmaceuticals-1503120682.html
ANI | October 13, 2022 9:21 am
...
According to the reports, Atlanta-based Atlantic Pharmaceuticals Company Ltd which has permission to export medicines to Gambia, ordered combined syrups bottles which were purchased from Maiden Pharmaceuticals limited...

 

[Pathfinder]

WEEKLY BULLETIN ON OUTBREAKS
AND OTHER EMERGENCIES

Week 42: 10 - 16 October 2022
Data as reported by: 17:00; 16 October 2022
...
All events currently being monitored by WHO AFRO
...

Gambia Acute kidney injury Grade 2

Date notified to WCO 11-Aug-22
Start of reporting period 4-Jul-2022
End of reporting period 6-Oct-22

Total cases 81
Cases Confirmed
Deaths 69
CFR 85.2%

On 1 August 2022, the Epidemic and Disease Control Unit of the Ministry of Health in The Gambia reported an unusual event detected at the Edward Francis Small Teaching Hospital, the main tertiary hospital in the country. A total of 81 cases with 69 deaths ( CFR 85%) have been reported as of 6 October 2022. The median age is 17 years with a range of two to 84 months. The highest number of cases was among children under two years of age. The index case was traced to 4 July 2022. Patients presented with symptoms such as inability to urinate, fever, vomiting, and diarrhoea. In addition, 23 samples of medicines taken by these children were sent for toxicology testing, and four of the medicines were found to contain diethylene glycol and ethylene glycol. Further investigation is ongoing.


https://apps.who.int/iris/bitstream/handle/10665/363696/OEW42-1016102022.pdf

 

[Emily]

https://gambiana.com/what-do-we-know...rup-to-gambia/

What do we know about US-based firm that imported the deadly cough syrup to Gambia
in News — by Gambiana — October 12, 2022

https://www.reuters.com/world/africa...rm-2022-10-11/

October 20, 20225:13 PM UTC
Gambia police link child deaths to cough syrup imported by pharma firm
Reuters

BANJUL, Oct 11 (Reuters) - (This Oct. 11 story has been corrected to remove incorrect reference to pharmaceutical company based in United States in the first paragraph, and Atlanta in 4th & 5th paragraphs)
...
Atlantic Pharmaceuticals Company Ltd, which has permission to export medicines into Gambia, ordered a combined total of 50,000 bottles of those syrups, according to the police report. Reuters has been unable to determine where the company is based.

The firm is distinct from Atlanta-based Atlantic Pharmaceuticals, Inc., whose president Anthony Soscia told Reuters by email that his company "does not import or export any pharmaceuticals."...

But...

https://web.archive.org/web/20221022070637/https://www.capturabiopharma.com/the-team/

https://www.georgiacompanyregistry.c...r-actives-llc/

https://www.importgenius.com/importe...or-actives-llc

 

[Pathfinder]

WEEKLY BULLETIN ON OUTBREAKS
AND OTHER EMERGENCIES

Week 52: 19 to 25 December 2022
Data as reported by: 17:00; 25 December 2022
...
All events currently being monitored by WHO AFRO
...
Gambia Acute kidney injury Grade 2

Date notified to WCO 11-Aug-22
Start of reporting period 4-Jul-22
End of reporting period 23-Dec-22

Total cases `127
Cases Confirmed 82
Deaths 70
CFR 55.1%

On 1 August 2022, the Epidemic and Disease Control Unit of the Ministry of Health in The Gambia reported an unusual event detected at the Edward Francis Small Teaching Hospital, the main tertiary hospital in the country. The highest number of cases was among children under two years of age. The index case was traced to 4 July 2022.

Patients presented with symptoms such as inability to urinate, fever, vomiting, and diarrhoea. Samples of medicines taken by these children were sent for toxicology testing, and four of the medicines were found to contain diethylene glycol and ethylene glycol. As of 23 December 2022, 127 cases were reported including 82 confirmed, six probable and 39 sespected cases. Of the confirmed cases, 70 deaths were recorded (CFR 85.4%). The last confirmed case was identified on 5 October 2022. Response activities are going on.

https://apps.who.int/iris/bitstream/...1925120222.pdf

 

[Shiloh]

Source: https://windsorstar.com/pmn/business-pmn/gambian-doctors-fight-to-ban-toxic-indian-syrup

Gambian doctors' fight to ban toxic Indian syrup
Reuters
Edward Mcallister and Jennifer Rigby and Krishna N. Das
Published Mar 10, 2023 • 13 minute read

BANJUL — Last July, more than 20 children were admitted to the Paediatric Emergency Unit of the Edward Francis Small Teaching Hospital in Gambia with kidney failure. Many received dialysis, the usual treatment.

Nearly all died.

Doctors were mystified, four of them told Reuters: They usually see one or two such cases a year. Consultant pediatrician Vivian Muoneke, a 33-year veteran, was scared.

“I had never seen anything like this,” she said. “It was like an epidemic.”

It was the rainy season; Gambian health ministry officials thought the problem was contaminated water. But Muoneke and her colleagues suspected the children had been poisoned.
Article content

Three months later, the deaths of more than 70 Gambian children from Acute Kidney Injury were linked by global health officials to cough syrups made in India and contaminated with ethylene glycol (EG) and diethylene glycol (DEG). The patients were the first of about 300 children killed worldwide last year by contaminated cough syrups, not all of them made in India. It was the deadliest total poisoning on record from toxins that have been known to scientists for decades.

As authorities search for a culprit in this case, the story of how the Gambian doctors raised the alarm, then pushed for weeks for health officials to test for chemical poisoning and ban cough syrup sales, has not been previously reported.

Delays in testing the medicines cost weeks. When completed with help from the World Health Organization (WHO), the tests showed the medicines contained extremely dangerous levels of the toxins and had been sold in bottles wrongly labeled as WHO-approved, Reuters found.
Article content

Pharmaceutical experts have warned for years about lax oversight of drugs made in India, whose industry supplies nearly half of the generic medicines used in Africa. India’s health regulator says it found no fault with the medicines.

The Gambian case appears to be the first documented example of DEG poisoning from imported rather than domestically produced medicines, a group of experts from Gambia and the U.S. Centers for Disease Control and Prevention said. The tragedy shows the difficulties faced by a poorly resourced country in identifying and removing harmful products, the experts said.

“There is not enough consequence when your drugs have been found to fail quality tests in a small African country,” said Jude Nwokike, vice president of the Promoting the Quality of Medicines Program at U.S. Pharmacopeia (USP), a non-profit partly funded by the United States that helps set drug-making standards globally. “That really needs to change.”...

 

[Pathfinder]

Four Indian medicines responsible for 70 child deaths in Gambia

By Philip Andrew Churm with AFP
Last updated: 22/07 - 14:56
GAMBIA

Four types of medicine, made in India, caused the deaths of at least 70 children in Gambia last year, according to a presidential commission of inquiry.

According to the World Health Organisation the syrups contained "unacceptable" quantities of diethylene glycol and ethylene glycol; commonly used as antifreeze. The chemicals can be fatal and led to acute kidney failure in dozens of children.

In October 2022, Gambia recalled a number of medicines following the deaths of the children, including all cough and cold syrups in circulation, as well as all products manufactured by the Indian firm Maiden Pharmaceuticals, where the contaminated syrups came from.

The inquiry concluded that the medicines had not been registered with the medicines control agency prior to being imported, as required by the regulations.

The commissions also noted the urgent need to set up a quality control laboratory to carry out tests on all medicines imported into the country.

...

​https://www.africanews.com/2023/07/...es-responsible-for-70-child-deaths-in-gambia/

 

[Michael Coston]

WHO Issues 6th Alert On Contaminated Cough Syrup




#17,604

For the 6th time in less than a year the World Health Organization has issued a medical product alert on liquid OTC medicines - manufactured primarily in India - containing dangerous (even fatal) amounts of diethylene glycol (DEG) and /or ethylene glycol (EG) as contaminants.

Starting in 2022 we began to see clusters of deaths around the world - usually in children - which were eventually linked to the consumption of adulterated pediatric cough syrups.​

A guidance document, released by the US FDA earlier this year describes the recent surge in cases.

In 2022 and 2023, numerous countries reported incidents of oral liquid drug products, primarily indicated for children, with confirmed or suspected contamination with high levels of DEG and EG.6 The cases of contamination, spanning at least seven different countries, were associated with more than 300 fatalities—mostly in children under the age of 5.7 In October 2022, and as part of the investigation into these cases, the Indonesian health authorities identified the presence of DEG and EG in a propylene glycol excipient used in manufacturing oral liquid drug products.8 At the time of issuance of this guidance, FDA had no indication that any contaminated products connected to the recent international incidents have entered the U.S. drug supply chain.


The 2022 outbreak resembles previous ones, as manufacturers of oral liquid drug products relied upon COAs provided by suppliers where the chain of custody or distribution history of the highrisk drug component was also not readily known or apparent from the COA. For example, in one instance, the appearance of the label and COA of propylene glycol, used as a component of a drug product, suggested the component container’s content might differ from what the container label and COA stated. As a result of these practices, DEG- and EG-contaminated components, such as propylene glycol, entered the pharmaceutical raw material supply chain.​

First the latest WHO Alert, then we'll have more on the plethora of adulterated and counterfeit drugs being sold around the world.

Medical Product Alert N°6/2023: Substandard (contaminated) syrup medicines​

Substandard (contaminated) syrup medicines identified in WHO Region of the Eastern Mediterranean​

7 August 2023 Medical product alert Geneva​

Alert Summary

This WHO Medical Product Alert refers to one batch of substandard (contaminated) COLD OUT syrup (Paracetamol and Chlorpheniramine Maleate) identified in the Republic of Iraq and reported to the World Health Organization (WHO) on 10 July 2023 by a third party. Please refer to the Annex of this Alert for full details of the affected batch of the product.

Paracetamol and chlorpheniramine combination syrups are used to treat and relieve symptoms of the common cold and allergy symptoms.

A sample of the COLD OUT Syrup was obtained from one location in Iraq and submitted for laboratory analysis. The sample was found to contain unacceptable amounts of diethylene glycol (0.25%) and ethylene glycol (2.1%) as contaminants. The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%.

The stated manufacturer of the affected batch of the product is FOURRTS (INDIA) LABORATORIES PVT. LTD, and the product is stated to be manufactured for DABILIFE PHARMA PVT. LTD. - INDIA. To date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product.

The product referenced in this Alert may have marketing authorizations in other countries or regions. It may also have been distributed, through informal markets, to other countries.

Please refer to the Annex of this Alert for full details of the affected products.

WHO has previously published five Alerts on other contaminated liquid dosage medicines. Please see Medical Product Alert N°6/2022, Medical Product Alert N°7/2022, Medical Product Alert N°1/2023, Medical Product Alert N°4/2023 and Medical Product Alert N°5/2023.

Risks

Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.

The substandard batch of the product referenced in this Alert is unsafe and its use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.​

Advice to regulatory authorities and the public

If you have the affected product, WHO recommends that you do not use it. If you, or someone you know, has, or may have used the affected product, or suffered an adverse reaction or unexpected side-effects after use, you are advised to seek immediate medical advice from a healthcare professional.

While this Medical Product Alert relates to only one batch of the product (as set forth in the Annex hereto), out of an abundance of caution, WHO recommends increased vigilance and testing in respect of the product in general.​

(Continue . . . )​

Despite the efforts of watchdog and police agencies around the globe, the world remains awash in substandard, contaminated, or otherwise dubious pharmaceuticals.

While many are OTC (over-the-counter) medicines, we've seen reports of adulterated prescription medicines as well.​

In 2012 we looked at a Lancet Report: 1/3rd Of Malaria Drugs Fake Or Sub-Standard, followed in 2013 by a study on Substandard & Falsified TB Drugs. In 2015 the AJTMH (The American Journal of Tropical Medicine and Hygiene) and NIH released a series of reports on The Threat From Fake & Substandard Pharmaceuticals.

Also in 2015, we saw a report in The Lancet: WHO Estimates That 50% Of Drugs For Sale Online Are Fake.​

In 2017, Changchun Changsheng Life Sciences Limited allegedly sold 500K doses of defective diphtheria, pertussis, and tetanus (DPT) vaccine, while the following year we saw an avian influenza vaccine scandal in Taiwan (see Taiwan's Counterfeit AI Vaccine Trade).

In 2018, we saw Media Reports: Scores Of `Counterfeit' Drugs Removed From Punjab Hospitals, while more recently our own government has repeatedly warned of substandard and unsafe PPEs and hand sanitizers flooding the market during the pandemic (see NIOSH & FDA Updates On Counterfeit N95 Respirators & Hand Sanitizers).

These products aren't just ripping off billions of dollars from consumers each year, in some cases they are contributing to rising antimicrobial resistance (AMR), they may leave some people inadequately treated for potentially serious diseases - and as described above - may be lethal in their own right.​

Every summer for the past 15 years Interpol has conducted a global special operation to clamp down on these fake, and often dangerous drugs, in Operation Pangea (see 2020's Interpol Warning On Fake/Counterfeit COVID Vaccines).

For an overview of their operations, you can visit Interpol's Pharmaceutical crime operations website:


​https://afludiary.blogspot.com/2023/08/who-issues-6th-alert-on-contaminated.html

 

[sharon sanders]

bump this