This WHO Medical Product Alert refers to a sub-standard (contaminated) batch of METHOTREXTM (methotrexate) 50 mg, identified in two countries (Yemen and Lebanon) in the WHO Eastern Mediterranean region. Methotrexate is in the WHO Model List of Essential Medicines and is indicated for the treatment of cancer and autoimmune diseases.
Substandard medical products are products that do not meet your quality standards or specifications and are therefore “out of specification.”.
After Adverse Events in Pediatric Patients Receiving METHOTREXTM 50 mg, the Yemeni and Lebanese health authorities performed microbiological analysis on the remaining unopened vials of METHOTREXTM 50mg. The results in both countries were positive for Pseudomonas aeruginosa, indicating product contamination.
The declared manufacturer, CELON Laboratories Pvt Ltd., has confirmed to WHO that the combination of batch number, manufacture and expiration dates mentioned above is consistent with its internal records. At this stage, they have not had access to samples of the suspect products for their own confirmatory tests.
Methotrexate is a chemotherapy agent and an immune system suppressor. It can be administered intrathecally, intramuscularly, intravenously, or intraarterially. Patients receiving methotrexate treatment may have weakened immune systems and be more vulnerable to opportunistic infections.
Pseudomonas aeruginosa Bloodstream infection is a serious infection that can cause death and any contaminated product administered directly into the body would pose serious risks to patients.
METHOTREXTM The 50mg batch MTI2101BAQ was intended to be sold exclusively in the Indian market. METHOTREXTM The 50 mg lot of MTI2101BAQ available in Yemen and Lebanon was purchased outside of the regulated supply chain. Therefore, the mentioned manufacturer cannot guarantee the safety of this product which was not intended for these markets.
However, it is likely that this product has been distributed to other countries through informal markets. It is important to detect and remove this contaminated product from circulation to prevent harm to patients.
Advice to regulatory authorities and the public
WHO calls for increased vigilance and diligence within the supply chains of countries and regions likely to be affected by this product. Increased surveillance of the informal/unregulated market is also recommended. Competent authorities are advised to notify WHO immediately if this product is discovered in their respective market.
Manufacturers are encouraged to test for microbial contamination before batches of finished products are released for use.
All medical products must be approved and obtained from authorized/licensed providers. The authenticity and physical state of the products must be carefully verified. Seek the advice of a health professional when in doubt.
If you have these poor products, please DO NOT use them. If you, or someone you know, has used them or suffered any adverse reaction/event after use, you are advised to seek immediate medical attention from a qualified healthcare professional and report the incident to the National Regulatory Authority or to the National Center for Pharmacovigilance.
If you have any information about the manufacture or supply of these products, please contact WHO at [email protected]
Please see the annex for details of the substandard products referenced in Alert No. 8/2022.
Alert n° 8/2022 may be updated if more relevant information becomes available
WHO Global Surveillance and Monitoring System
for substandard and counterfeit medical products
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