Contaminated medicines affecting children

Contaminated medicines are medicines that are potentially unsafe for use or ineffective because they contain foreign substances or organisms including some physical, chemical, biological, or radiological substance or matter that should not be present according to the product’s specifications.

Medicines can be contaminated when they are produced in inadequately controlled settings by poorly trained personnel, and/or shipped or accidentally stored without respecting the necessary standards. On some occasions, medicines are contaminated on purpose, for example, to save money or because an ingredient is hard to find or buy.

It is estimated by WHO that up to one in ten medicines sold globally in low- and middle-income countries may be substandard, including ones that may be harmful to humans, or falsified.[1]

Some contaminated medicines can cause severe sickness and even death.

To reduce the risks associated with contaminated medicines, it is recommended that patients only take medicines that have been directly obtained from an official or accredited pharmacy, from a registered healthcare professional, or from a licensed healthcare facility or hospital.

Contaminated medicines are a long-standing and ongoing global concern; however, recently several countries in Africa, Asia Pacific, and Europe have identified and reported medicines that have been contaminated and are dangerous to human health.

Between October 2022 and April y 2023, in The Gambia, Indonesia, Uzbekistan, Cambodia, Marshall Islands, and Micronesia (Federated States of) a series of contaminated medicines (such as cough syrups) have been reported. More than 300 people, mainly children, have reportedly died after having potentially taken one of these contaminated products. 

Since September 2022, WHO has received multiple reports from countries about 15 suspected contaminated medicines (listed below), with the potential to cause serious illness or deaths.

All these contaminated medicines are liquid medicines, often called syrups. They include cough syrups, commonly sold over the counter in many countries for use for children. Some syrups are labelled as containing paracetamol and include syrups used to treat pain, fever, cough or flu. One syrup is an antihistamine, and one iron/vitamin liquid product has also been identified.

All batches or lots of contaminated syrup medicines that are listed below have unacceptably high levels of ethylene glycol and diethylene glycol, which are toxic chemical substances used as antifreeze agents and industrial solvents that can be fatal even if consumed in small amounts and should never be found in medicines.

The names of contaminated syrup medicines that could cause severe illness or death are listed below:

Since September 2022, WHO has received multiple reports from countries about 15 suspected contaminated medicines (listed below), with the potential to cause serious illness or deaths.

All these contaminated medicines are liquid medicines, often called syrups. They include cough syrups, commonly sold over the counter in many countries for use for children. Some syrups are labelled as containing paracetamol and include syrups used to treat pain, fever, cough or flu. One syrup is an antihistamine, and one iron/vitamin liquid product has also been identified.

All batches or lots of contaminated syrup medicines that are listed below have unacceptably high levels of ethylene glycol and diethylene glycol, which are toxic chemical substances used as antifreeze agents and industrial solvents that can be fatal even if consumed in small amounts and should never be found in medicines.

The names of contaminated syrup medicines that could cause severe illness or death are listed below:

If you are in possession of any of the abovementioned contaminated syrup medicines, WHO recommends that you do not use them and that you contact a qualified healthcare professional for guidance on alternative medicines. If you, or someone you know, has or may have used any of the contaminated products, or suffered an adverse reaction or unexpected side-effect after their use, you are advised to seek immediate medical advice and care from a qualified healthcare professional who should, in turn, report the incident to the national pharmacovigilance center or  national regulatory authority responsible for medicines. 

Confirmed contaminated syrup medicines (following testing) have so far been detected in at least 5 countries: The Gambia, Indonesia, Uzbekistan, Cambodia, , Marshall Islands, and Micronesia (Federated States of).

However, potentially contaminated syrup products have also been reported in some other countries. While these countries have not reported to WHO any adverse events in patients arising from the use of such potentially contaminated medicines, they have acted to remove these medicines as a precaution to protect people from possible harm.  

It is vital that government, regulators, distributors, retailers, healthcare professionals and the public at large remain vigilant. This includes helping to identify, report, avoid and stop the use of any contaminated syrup medicines that may still be circulating in-country, whether at pharmacies, clinics and hospitals or through informal markets such as street or market stalls or on unregulated websites. 

Contaminated medicines that have been detected by national authorities have been put under surveillance. Efforts are continuing to ensure their use is stopped and that further sale or distribution of these products does not continue.

WHO works constantly with regulators, manufacturers and other partners including the public to prevent, detect and respond to incidents related to contaminated medicines.

Since these contaminated medicines were detected, WHO has issued several global medical product alerts (listed above) urging action to protect children and others from contaminated medicines. Those medical product alerts provide details on the contaminated syrup medicines that should not be used.

Additionally, WHO is working with countries to promote securing the supply chains of the raw materials used to manufacture these products.

Based on currently available evidence, children under 5 years are most at risk of potentially developing severe illness or dying after consuming the abovementioned contaminated syrup medicines. 

It can be very difficult to tell if a medicine is contaminated. Many medicines that are contaminated can look, smell, or taste like the non-contaminated products.

This is why countries must have rigorous and continuous safety checks on medical products to detect and destroy contaminated medicines, whenever possible.

This is also why you should only take medicines that have been obtained from an accredited pharmacy, from a registered healthcare professional, or from a licensed healthcare facility or hospital.

These are toxic chemical substances typically used in antifreeze solutions for air-conditioners, fridges and freezers, and as a solvent for many products, including cosmetics at very low concentrations. These chemical substances should never be used in medicines, as they can be fatal even if taken in small amounts. 

If you suspect that you are in possession of a contaminated medicine, WHO recommends that you do not use it.

If you or someone you know has or may have used a contaminated medicine, or suffered an adverse reaction or unexpected side-effect after taking a medicine, you are advised to alert and seek immediate medical advice and care from a qualified healthcare professional who should, in turn, inform the national regulatory authorities for medicines or the national pharmacovigilance center.  

Contaminated syrup medicines may result in serious injury or death. Side-effects of syrup medicines contaminated with diethylene glycol and ethylene glycol include pain in the stomach, vomiting, diarrhoea, inability to pass urine, headache, altered mental states such as confusion, and acute kidney injury which may lead to death.

There may be other unknown harmful side-effects. WHO and national authorities are continuing to monitor any other potential harmful side effects which may be reported.

Every time you use a medicine, WHO recommends that you:

• Examine the packaging for its overall condition, spelling mistakes or grammatical errors;
• Check the manufacturing and expiry dates, and verify that any dates and other details on the outer packaging (pack or box) of the medicine match the dates and other details shown on the inner packaging (bottle or blister strip) of the medicine;
• As far as you can tell, confirm that the medicine looks correct and that it is not apparently discoloured, degraded or has an unusual smell; and
• If you or someone you know has or may have used medicine that you know or suspect to be contaminated, or have suffered an adverse reaction or a side-effect that is unexpected after its use, then please seek immediate medical advice and care from a qualified healthcare professional.

WHO issued four global medical alerts addressing these reported incidents in The Gambia, Indonesia, Cambodia, Uzbekistan, Marshall Islands and Micronesia (Federated States of). These medical product alerts were rapidly disseminated to the national health authorities of all 194 WHO Member States.

In addition, on 23 January 2023, WHO published a call to action to various key stakeholders (i.e., governments, regulators, and manufacturers, suppliers and distributors of medicines) to protect children from contaminated medicines.  As part of this publication, WHO called for a series of actions including (but not limited to):

1. The detection and removal of contaminated medicines from circulation in the markets,
2. Increased surveillance and diligence within the supply chains of countries and regions likely to be affected,
3. Immediate notification to WHO if these substandard products are discovered in-country; and otherwise inform the public of the dangers and side-effects of the substandard medicines at issue.

WHO continues to work with the Member State Mechanism on substandard and falsified medical products in implementing its mandate to promote effective collaboration in the prevention, detection and response to substandard and falsified medical products to save lives.