The World Health Organization has issued a Medical Product Warning against Methotrexate formulations marketed in Lebanon and Yemen. Methotrexate is one of the well-known drugs used in chemotherapy for the treatment of cancer and as an immunosuppressant agent. Because of its importance in treating such crucial diseases, the drug is on the list of essential medicines WHO. The WHO issued a product warning for a defective batch of Methotrexate brand, METHOTREX which has been circulated in Yemen and Lebanon.
Methotrexate is an anticancer and immuno-suppressant drug that can treat several autoimmune diseases. The WHO said that the batch of METHOTREX 50 mg was of a substandard quality that can have many potential adverse reactions or produce subpar results in terms of treatment. Substandard medical products are products that do not pass the quality standards set by regulatory authorities. The substandard batch was identified when elderly patients, who were prescribed this brand of methotrexate, showed adverse reactions. These complaints were soon addressed by the healthcare authorities in Yemen and Lebanon. The healthcare authorities did microbial testing on the samples of METHOTREX 50 mg to understand the defects. Based on these microbial testing, the healthcare authorities of these countries found out that the METHOTREX 50 mg was contaminated and contained Pseudomonas aeruginosa. Pseudomonas aeruginosa is bacteria belonging to the Pseudomonas family, which includes some of the most lethal bacteria to animals and humans. Pseudomonas aeruginosa can cause infections in the lungs, blood, and open wounds. Upon confrontation by the healthcare authorities, the manufacturer of METHOTREX 50 mg, CELON Laboratories Pvt Ltd said that the information mentioned on the product related to the expiry date of the product matched with their data, indicating that there was no contamination from their side.
Despite this, seeing the severity of being contaminated with Pseudomonas aeruginosa, the WHO decided to issue a product warning for methotrexate formulation by CELON Laboratories Pvt Ltd. Methotrexate have immuno-suppresant qualities, which means that patients who have been prescribed Methotrexate will have a suppressed immune system, leaving them wide open for infections. Having suppressed immunity also means that the infections which are mild for normal people will be dangerous or even lethal for patients consuming Methotrexate. This is especially true if Pseudomonas aeruginosa infects the blood of the patient. In such cases, the patient has a higher chance of producing a lethal infection, as it allows the bacteria to spread throughout the body through the bloodstream.
The WHO also guided the local healthcare authorities to avoid such incidents in the future. The WHO said that the local authorities should increase the surveillance and diligence related to the supply chains of medicinal products. It also directed local authorities to let the WHO know about future cases of contaminated medications found in the region. WHO also directed the manufacturers to be aware of such contamination and to do a final quality check before releasing the product on the market. For customers or retailers, the WHO suggested acquiring products only from authorized suppliers or drug dealers.