Minilabs save lives

Minilab double training in the South Pacific: Behind the horizon and beyond it goes on

Shortly before the coronavirus pandemic, 15 Minilabs were sent to the Western Pacific Regional Office of the World Health Organisation (WHO) in the Philippines, which, after the pandemic, will now be gradually delivered to their final destination, the island countries in the South and North Pacific. This is the background against which two Minilab training courses took place in Tonga and Nauru in April and May this year. Minilab project manager Dr Richard Jähnke travelled to the South Pacific at the invitation of the WHO Division of Pacific Technical Support in Fiji and trained 8 government pharmacists on Tonga and 6 government pharmacists on Nauru in the correct use of Minilab test protocols for the detection of substandard and falsified medicines. Falsified medicines are increasingly becoming a problem worldwide, including the Pacific region, and have a significant negative impact on the WHO goal of universal access to functioning health systems, including access to effective medicines. If the shortage of skilled labour in Germany is a recent generational problem, the shortage of skilled labour in the Pacific island countries is a permanent issue. There is a shortage of everything: pharmacists, doctors and nurses et al. There is also a lack of money, so the island countries are heavily dependent on foreign aid and aid from UN agencies. The current GPHF mission and the Minilab trainings are intended to help strengthen the local regulatory systems in the area of health and medicines. Such a mission has already been supported by the Asian Development Bank for Samoa in the past. GPHF-Minilabs have now been established in Fiji, Tonga, Nauru and Samoa, hence, in 4 out of 21 Pacific island countries, and the WHO plans to support more island countries with GPHF-Minilabs and user trainings in the near future.

WHO warns of falsified DOW USP/EP PROPYLENE GLYCOL

Found in Pakistan, this contaminated raw material intended for pharmaceutical use poses serious health risks. Investigations by the Pakistan Drug Administration revealed contamination with ethylene glycol, a toxic substance. DOW confirmed that it is a falsified excipient that may have been distributed worldwide. Ingestion of ethylene glycol can have fatal consequences, particularly in children, and can cause symptoms such as abdominal pain and acute kidney damage. Manufacturers, distributors and regulators are urged to ensure the safety of raw materials and report adverse events immediately to prevent harm. The Global Pharma Health Fund (GPHF) intends to add to its Minilab a fast and non-expensive detection test protocol on diethlene/ethylene glycol contaminations for syrups soon.

https://www.who.int/news/item/15-04-2024-medical-product-alert-n-1-2024--falsified-(contaminated)-usp-ep-propylene-glycol

Mali strengthens surveillance of medical products

Due to the high maternal mortality rate and the prevalence of malaria, which particularly affects children and pregnant women, Mali has intensified its monitoring measures for medical products. The country has taken measures to ensure the quality of medicines, including recalling substandard or falsified medical products and improving regulatory systems.

To optimise surveillance, the National Health Laboratory (LNS) and the Directorate of Pharmacy and Medicines (DPM) have introduced a risk-based approach to post-market surveillance (RB-PMS). This approach focuses resources on high-risk medicines and sites and rationalises sampling and testing procedures. For the chemical and pharmaceutical testing, the Minilab of the Global Pharma Health Fund (GPHF), a non-profit organisation voluntarily supported by Merck KGaA (Germany), was used.

In a recent round of RB-PMS, medicines for malaria and for maternal, newborn and child health (RMNCH) were sampled in different regions. The results showed that 6% of the medicines were substandard or counterfeit, especially RMNCH products such as oxytocin and diazepam. Many of the medicines analysed were not registered with the Ministry of Health.

The Koulikoro region had the highest percentage of substandard or falsified samples, with a significant proportion coming from India and China. To address these issues, Mali, under the leadership of the Ministry of Health, intends to strengthen its legal framework for drug regulation.

Following the findings of the RB-PMS, Mali has taken enforcement measures such as the withdrawal of substandard and fake batches and quarantine of affected products. In addition, awareness campaigns were conducted in healthcare facilities, pharmacies and the public to inform them about the presence of falsified medicines and the importance of quality assurance for medical products.

New diabetes drugs added to the GPHF-Minilab method inventory

The GPHF-Minilab now includes six new drugs to help in detecting their substandard and falsified versions in an easy and affordable manner and to help in combatting the increasing prevalence of spurious diabetes medicines worldwide. These drugs, such as empaglifozin, gliclazide and sitagliptin, are crucial for the treatment of diabetes, especially in low-income countries where the disease is rapidly increasing. It is essential to ensure that diabetes medicines are genuine and effective. Substandard and falsified diabetes medicines are a growing problem, as recent cases of fake semaglutide pens for parenteral use show (https://www.safemedicines.org/2023/06/fake-semaglutide.html). To counteract this, the Minilab now covers a total of seven oral diabetes medications, including fixed-dose combination products. In total, the Minilab now offers methods for testing 119 different active pharmaceutical ingredients covering various diseases such as diabetes, cardiovascular disorders, many infections (malaria, tuberculosis and AIDS) and much more. The new addition to the expanded method inventory of our Minilab is now available as a booklet for free download in English, French and Spanish at https://www.gphf.org/en/minilab/manuals.htm.

Prevent, detect and respond to fake medicines

Mrs Permette Bourdillon-Esteve, who cares about the safety and quality of medical products at the World Health Organization (WHO), talks in this video on how to prevent, detect and respond to the issue of substandard and falsified (SF) medical products circulating in the markets in particular of low- and middle-income countries. Laboratory testing for medicines identification is an essential step forward and this is where the Global Pharma Health Fund (GPHF) and its mini-laboratory (Minilab) comes in for capacity building during post-marketing medicines surveillance (PMS).

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More Contaminated Syrups and Suspensions Identified

The recent WHO Medical Product Alert, issued on 7 December 2023, highlights concerns about five syrup and suspension medicines manufactured by PHARMIX LABORATORIES (PVT.) LTD and initially detected in the Maldives and Pakistan by the appropriate Drug Regulation Authorities when screening samples on non-compliance. Some of the affected products have also been detected in Belize, Fiji and Lao People’s Democratic Republic. These products, including ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension, and ZINCELL Syrup, have been found to contain potentially unacceptable levels of diethylene glycol and ethylene glycol. The contamination was confirmed by the Therapeutic Goods Administration of Australia, leading to a follow-on inspection of the manufacturing facility by the Drug Regulatory Authority of Pakistan. As a precautionary measure, PHARMIX LABORATORIES has been instructed to halt production of all oral liquid dosage medicines. While no adverse effects have been reported to WHO, increased vigilance and testing are recommended for oral liquid dosage medicines produced by PHARMIX LABORATORIES between December 2021 and December 2022. The affected products may have been distributed internationally, and diethylene glycol (DEG) and ethylene glycol (EG) are toxic to humans when consumed and can prove fatal. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death. This alert follows six previous WHO alerts on other contaminated liquid dosage medicines. For more details go to https://www.who.int/news/item/07-12-2023-medical-product-alert-n-8-2023--substandard-(contaminated)-syrup-and-suspension-medicines

The Minilab of the Global Pharma Health Fund (GPHF) Presented at the World Health Summit 2023 in Berlin: Important Building Block for the Protection against Fake Medicinal Products

At the World Health Summit in Berlin, experts celebrated the 25th anniversary of the GPHF-Minilab®, highlighting its vital role in combating falsified and substandard medicines. While acknowledging the complexity of the issue, Dr. Jutta Reinhard-Rupp of the GPHF emphasized the Minilab's significance due to its mobility, ease of use, reliability, and cost-effectiveness. With over 1,000 units deployed globally, the GPHF-Minilab plays a crucial part in safeguarding lives. Pernette Bourdillon-Esteve of the WHO emphasized the threat falsified and substandard medicines pose to public trust in healthcare systems. She stressed the importance of comprehensive monitoring to identify fake drugs promptly. Practical experiences shared by experts from Kenya, Uganda, and Nigeria underscored the Minilab's efficacy in swiftly detecting counterfeits. The GPHF announced plans to expand its mobile lab's capabilities by integrating new pharmaceutical ingredients, aiming to increase the current 112 to 125 by 2025. They remain open to future technical innovations to enhance their testing methodology further.

GPHF-Minilab production site turns 40

Our Minilab production site Technologie Transfer Marburg (TTM) turned 40 and celebrated last week. At the same time, our Minilab will be 25 years old this October. This will be celebrated at the World Health Summit (WHS) in Berlin. Let Minilab output speed match the beat counts of the drummer in the future. Cheers!

East African Community begins implementation of Minilab projects

The East African Community (EAC) Regional Centre of Excellence, in collaboration with the EAC Secretariat, has handed over 16 GPHF-Minilabs to enhance regional efforts to detect and rapidly eliminate counterfeit medicines in the regional market.

The Minilabs and accessories were handed over to six EAC Member States (Rwanda, Uganda, Burundi, Kenya, South Sudan and the United Republic of Tanzania) in Kigali on 18 August 2023 after intensive training of two staff members from each country.

The Minilab project is an initiative of the University of Rwanda/ East Africa Community Regional Centre of Excellence for Vaccines Immunization and Health Supply Chain Management (UR/EAC RCE-VIHSCM) and the EAC Secretariat.

The project received a generous grant worth €400,000 from the German Government, the Federal Ministry of Economic Cooperation and Development (BMZ) through the German Development Bank (KfW) and will be implemented until 2026.

The Minilab itself was developed by the Global Pharma Health Fund (GPHF), a non-profit organisation funded exclusively by voluntary donations from Merck KGaA (Germany).

The GPHF-Minilabs serve to protect patients from consuming substandard and falsified medicines in case such products enter fragile and poorly regulated pharmaceutical supply chains.

Substandard cough syrups made in India travelling the world

The circulation of cough syrup contaminated with EG/DEG in Iraq, as uncovered by Bloomberg News, has prompted a swift response from the World Health Organization (WHO). The relevant medical product alert can be accessed via the following link: https://tinyurl.com/yrs7vjp2. As per the alert, ethylene/diethylene glycol levels in cough syrup should not exceed 0.1%, yet the Cold Out batch contained approximately 2.35% of these substances. Despite the thriving Indian Pharma industry, it is perplexing that cough syrup exporters are opting for subpar non-pharmaceutical grade glycol to cut costs, thereby endangering the well-being of infants and children worldwide. Consequently, a recommendation for the imposition of an export/import prohibition on liquid cough syrups from India seems justifiable until robust and impartial quality control measures are implemented for such cold medicines.

Indian-Made Cold Syrup Sent to Iraq Contains Poison, Test Shows

Sample of Cold Out contaminated with toxic ethylene glycol. Bloomberg tested 33 Indian syrups bought in six countries. A cold medication made in India and sold in Iraq is tainted with toxic chemicals, a test commissioned by Bloomberg News shows, the latest in a series of alarming revelations about syrup medicines used by children around the world. For more details go to https://tinyurl.com/mr449hxc

Zachary Mider on Twitter “PLEASE SHARE. We published a story today about Cold Out, an over-the-counter cold medication made in India and found on sale in Iraq. Our testing shows it is contaminated with ethylene glycol, a toxic industrial solvent. (thread) https://t.co/EJmPduSxMF”

The Bitter Tincture of Trust: More contaminated cough syrups found in Cameroon

More than twenty-five years ago a significant case of diethylene glycol (DEG) intoxications from child cough syrups occurred in 1996 in Haiti, where a tragic incident known as the "Haitian Cough Syrup Poisonings" took place. In this incident, several children died and many others fell seriously ill after consuming cough syrup that was found to be contaminated with DEG. Last year again, about 70 babies were dying in Gambia after getting cough syrup from India. Soon after, contaminated cough syrups traveled the world. Produced in India moving then to Indonesia and Uzbekistan and even to Micronesia and the Marshall islands in the Pacific. When it comes to pharmaceutical quality trust is a bad adviser as shown again in the recent global medical product alert issued by the World Health Organization (WHO) over toxic antifreeze agent (DEG) found in Cameroonian cough syrups produced by a non-existent manufacturer allegedly based in the UK according to label claim on the fake bottle packaging. Apparently, other criminal groups are now hopping on and are hiding beyond the DEG cases made in India. USP Promoting the Quality of Medicines Plus (PQM+) program, the Global Pharma Health Fund (GPHF) with its Minilab project and other initiatives are there to help and eradicate the proliferation of substandard and falsified medicines (FSM). There will be no universal health coverage without pharmaceutical quality. The substandard products referenced in this Alert are unsafe and their 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. For more, consult the WHO alert here https://tinyurl.com/44fmej6y

Poisoned Cough Syrup Killed Kids. Babies dying in Gambia after getting cough syrup from India.

Authorities Cut the Investigation Short. Make no mistake: the whole world is vulnerable thanks to global supply chains and the push for profits. Toxic chemicals were found in Indian-produced medicine that led to the deaths of dozens of children. It revealed how poorly the country’s pharmaceutical industry is policed.

Michelle Fay Cortez on Twitter “Babies dying in Gambia after getting cough syrup from India. Make no mistake: the whole world is vulnerable thanks to global supply chains and the push for profits. This is the investigation that wasn't: https://t.co/sbOBFSaGqr via ”

The war destroyed everything in Yemen incl. the systems of pharmaceutical supplies. Substandard and falsified medicines are proliferating.

Apotheker im Jemen: »Der Krieg hat alles zerstört« Krieg, wirtschaftlicher Kollaps, Arzneimittelmangel – die Lage im Jemen ist verheerend. Vor welchen Herausforderungen die Apothekerinnen und Apotheke...

A special anniversary: the 1,000th Minilab recently delivered

It is a milestone for the Global Pharma Health Fund e.V. (GPHF), as the 1,000th GPHF-Minilab has been delivered these days. The mobile mini-laboratory, which bears the number 1,000 and can be used to detect substandard and falsified (SF) medicines, is part of an order for a total of 16 laboratory units that will be used in future in the countries of the East African Union in order to protect the people there from what is often a deadly danger: SF medicines. The National University of Rwanda is initially in charge of the local deployment and will conduct a training course for the future users of the labs. The 16 Minilabs were financed with funds from the German Bank of Reconstruction (Kreditanstalt für Wiederaufbau, KfW) in Frankfurt, nowadays one of the world’s leading promotional banks.

The GPHF-Minilab concept has now proven itself over two decades, in more than a 100 countries and across all continents. Dr Richard Jähnke of the GPHF, who designed the laboratory and performed himself training courses in numerous countries already: "Our method is simple, reliable and inexpensive. The staff in hospitals, in health stations or in governmental institutions is thus able to verify the quality of medicines available on site within a short period of time. This is a quantum leap in many places, because such possibilities often did not exist at all before and one can imagine what this means for patients locally."

In many cases, the GPHF-Minilab has already been able to detect and remove from circulation SF medicines, which are widespread especially in Africa and Southeast Asia. However, Dr Jähnke and the GPHF are constantly working on extending the application possibilities of the Minilab, for example, to include further active pharmaceutical ingredients in the Minilab’s method inventory. Currently, 113 priority medicines for the treatment of various diseases can already be identified and analysed. Planning for further active substances has already started. For more details go to www.gphf.org.

Contaminated cough syrups travel the world: More cases now in Pacific island countries

The World Health Organization (WHO) has issued an alert over a batch of contaminated guaifenesin cough syrup in the Marshall Islands and Micronesia. The product, manufactured by QP Pharmachem Ltd in Punjab, India, and distributed by Trillium Pharma in Haryana, India, contained unacceptable levels of diethylene glycol and ethylene glycol as impurities. These substances are toxic to humans and can be fatal if consumed. The product is unsafe and its use, especially by children, can lead to serious injury or death. WHO has already issued three alerts on cough syrups for children, due to cases in The Gambia, Indonesia and Uzbekistan. See the full alert here: https://tinyurl.com/53r7xcz8

Fake batches of defibrotide sodium circulating in UAE and Kyrgyzstan

The latest WHO Medical Product Alert is warning about a falsified batch of defibrotide sodium (DEFITELIO) that has been identified in the United Arab Emirates and Kyrgyzstan. The falsified products have been found in both UK/Ireland packaging and US packaging. DEFITELIO is an antithrombotic agent used to treat severe veno-occlusive disease (VOD) in adult and paediatric patients undergoing haematopoietic stem cell transplantation. The genuine manufacturer of DEFITELIO has confirmed that the products referenced in the Alert are falsified, and laboratory analysis has shown that they do not contain the stated active ingredient. The Alert provides further details about the affected products, including batch numbers and expiry dates that are falsified. See the full alert here: https://tinyurl.com/8jywe8p2

Further cardiovascular drugs added to the GPHF-Minilab method inventory

Six new cardiovascular drugs have been added to the GPHF-Minilab method inventory, most of which are blood thinners. These are apixaban, candesartan, clopidogrel, hydralazine, rivaroxaban and warfarin. Cardiovascular disease is one of the leading causes of death worldwide. Falsified cardiovascular medicines can therefore pose a pressing public health concern that has received little attention. To facilitate the monitoring of cardiovascular medications in low- and middle-income countries' supply chains, the Minilab's method inventory now encompasses a total of twenty such drugs. Including cardiovascular medications, the Minilab's method inventory now encompasses 113 active pharmaceutical ingredients (APIs) in various preferred formulations for treating both communicable and non-communicable illnesses, such as antibacterials, antimalarials, antivirals, anthelmintics, antidiabetics, antiasthmatics, analgesics, and cardiovascular and gastrointestinal drugs. All of the above agents are often combined with other drugs, e.g. clopidogrel with acetylsalicylic acid, which presents an additional challenge in the development of test methods. The new addition to the expanded method inventory of the GPHF-Minilab is now available for download in English, French and Spanish at https://www.gphf.org/en/minilab/manuals.htm, free of charge.

Fake medicines kill nearly 500,000 sub-Saharan Africans per year

According to a recent report by the United Nations Office on Drugs and Crime (UNODC), nearly half a million sub-Saharan Africans die each year as a result of the illicit trade in medicines (https://tinyurl.com/23zfr8jk).

In sub-Saharan Africa, as many as 267,000 deaths a year are linked to falsified and substandard antimalarial drugs, according to the UNODC transnational organised crime threat assessment. In addition, up to 169,271 deaths are linked to counterfeit and substandard antibiotics used to treat severe pneumonia in children. The World Health Organization (WHO) estimates that providing care to people who have used falsified or substandard medicines to treat malaria in sub-Saharan Africa costs between $12 million and $44.7 million each year.

International operations have seized more than 605 tonnes of medical products in West Africa between January 2017 and December 2021. Typically, these products enter through standard international trade channels, mainly by sea. Products are diverted from the legal supply chain and often enter the Sahel from major exporting countries, including China, Belgium, France and India. Others are produced in neighbouring countries.

Terrorist groups and non-state armed groups are often associated with the illicit trafficking of medical products in the Sahel, but their involvement is limited. At the same time, the UNODC report notes that investigations have uncovered a variety of actors involved in the illicit trade of medical products. Smugglers include pharmaceutical company employees, civil servants, law enforcement officials, health agency workers and street vendors.

The African Union established the African Medicines Regulatory Harmonization Initiative in 2009 to improve access to safe and affordable medicines. The effort is part of its Framework for Pharmaceutical Production in Africa. In addition, all Sahel countries except Mauritania have ratified a treaty establishing the African Medicines Agency. The Global Pharma Health Fund (GPHF) and its partners, the Promoting the Quality of Medicines Plus Program (PQM+) and the Ecumenical Pharmaceutical Network (EPN), detect substandard and counterfeit medicines on the ground by conducting post-market drug quality testing using GPHF-Minilabs, a mini-laboratory developed for rapid action and enhancing medicines testing capacities.

Fake medicines kill almost 500,000 sub-Saharan Africans a year: UNODC report Trafficked medical products kill almost half a million sub-Saharan Africans every year, and action is needed to stem the flow, the United Nations Office on Drugs and Crime (UNODC) states in its new threat assessment report.

Contaminated cough syrups: first The Gambia, then Indonesia and now Uzbekistan

Many of my followers will be aware of the recalls of paracetamol syrup and pediatric formulations of other medicines in The Gambia and Indonesia. Investigations are ongoing, but the evidence of a link between the use of non-pharmaceutical grade ingredients in these products and acute kidney failure, which has led to at least 178 deaths (mostly in children), is strong. The doctors who treated the children with kidney failure had no suspicion that the medicines could be to blame, and no reports were made through the national pharmacovigilance system.

After the World Health Organization (WHO) issued a warning on 5 October 2022 about the contamination of children's cough syrups in The Gambia, the Indonesian Medicines Agency (BPOM) launched a proactive investigation into children's syrups. By 20 October, it had identified a number of medicines and brands that may have been contaminated with diethylene glycol (DEG) or ethylene glycol (EG), or both, and initiated a nationwide recall, while other brands had to be quarantined pending further investigation.

Against this background, the recent WHO rapid alert draws attention to new cases of ED/DEG-contaminated cough syrups for children in Uzbekistan. For more information on this, visit https://tinyurl.com/62tub459

Medical Product Alert N°1/2023: Substandard (contaminated) liquid dosage medicines Alert SummaryThis WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical products are products that fail to meet quality standards or specifications and are therefore "out of specification"[1]...

Substandard, unsterile injectable cancer drugs discovered

Injectable cancer drugs of the methotrexate type contaminated with bacteria have been discovered in war-torn Yemen and crisis-ridden Lebanon, following adverse events and death in children. Methotrexate is on the WHO Essential Medicines List and is approved for the treatment of cancer and autoimmune diseases. The specified manufacturer, CELON Laboratories Pvt Ltd, has confirmed to WHO that the above combination of batch number, manufacturing date and expiry date is consistent with its internal records. At this stage, the company has not had access to samples of the suspect products for its own confirmatory testing. It is likely that this product was distributed to other countries through informal channels. It is important to locate and remove this contaminated product from circulation to prevent harm to patients. For more information, visit https://tinyurl.com/2re4w4x6 or https://tinyurl.com/y5csrewk.

GPHF-Minilab Training Mission to Fiji

The WHO Regional Office for the Western Pacific, based in Manila, Philippines, procured and disseminated five GPHF-Minilabs for its Department of Pacific Technical Support (DPS) in Suva, Fiji, in late 2019, just before the start of the Corona pandemic. Five Pacific Island Countries (Fiji, Tonga, Nauru, Tuvalu and the Solomon Islands) each received a GPHF-Minilab. After the end of the pandemic, Minilab training took place at the WHO training centre in Nadi (Fiji) at the end of November 2022. Dr. Richard Jähnke, pharmacist and project manager at the Global Pharma Health Fund (GPHF), was invited to train fifteen participants in the use of the Minilab. Most of the participants were pharmacists themselves and came from WHO/DPS, the Fiji National Regulatory Authority and hospitals across Fiji. Participants tested locally procured medicines for the first time in Fiji and are already looking forward to further support in procuring more Minilabs. The majority of pharmacists in Fiji are clinical pharmacists who have no experience in the field of medicine analysis. Closing this gap and supporting them in their fight against the proliferation of substandard and falsified medicines in the Pacific region was the reason for the GPHF mission to Fiji.

Gambia: Poisoned cough syrup. Dozens of children dead. Mothers demand justice

According to the latest data from the World Health Organization (WHO) and reports from the Gambian authorities, at least 66 young children in The Gambia may have died from acute kidney damage caused by contaminated cough and cold syrups. The Fight the Fakes Alliance condemns the spread of toxic substandard medicines and calls on world leaders to guarantee quality-assured medicines. The Drug Regulatory Authority of India has launched an investigation into reports of contaminated cough syrups made by an Indian company that led to the deaths of children in The Gambia, according to people familiar with the matter. Meanwhile, Gambian mothers are demanding justice. Such tragic events are preventable if governments and international bodies act at the right moment in the right place! https://www.bbc.com/news/world-africa-63171982

Gambia cough syrup scandal: Mothers demand justice Sixty-six Gambian children are thought to have died because they were given unsafe medicine.

Contaminated paediatric medicines identified in The Gambia

Laboratory analysis of suspicious samples from Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. These four products have been identified in The Gambia (West Africa), but may have been distributed, through informal markets, to other countries or regions. To date, the stated manufacturer from India has not provided guarantees to WHO on the safety and quality of these products. 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 that may lead to death. More on this, including pictures see at the appropriate WHO Medical Product Alert here: https://tinyurl.com/ykpv8je3.