The Food and Drug Administration (FDA) on Monday issued a warning urging hospitals, healthcare facilities, professionals, and the general public to cease the use of Methetrexate 100 milligrams/milliliters (mg/ml) solution for intramuscular (IM) and intravenous (IV) injections.

It explained that the nature of the quality problems of Trexasaph 100 mg/mL with Batch Number I123J001A was found positive with Pseudomonas aeruginosa.

"In the interest of public health and safety, all available batches should not be used or administered until further notice from this Office," the FDA said.

Pseudomonas aeruginosa bloodstream infection is a serious infection that may lead to death and any product that has any contamination and is administered directly in the body would present serious risks to patients.

Methotrexate is a chemotherapy agent and immune system suppressant.

It is indicated in the treatment of neoplastic diseases such as trophoblastic neoplasms and leukemia, and the symptomatic treatment of recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy.

It may be given intrathecal, intramuscular, or intra-aerial routes.

Meanwhile, patients receiving methotrexate treatment may have weakened immune systems and be more vulnerable to opportunistic infections.

The FDA reminded drug establishments involved with this product to implement risk management plans and take rapid actions when there is a probable cause of safety breaches.

"The accountability of drug establishments in product quality and safety in this case is being studied by FDA with an end in view for levying appropriate penalties," it said.

"The FDA enjoins medical professionals, administrators of the health facilities, and the public to monitor the FDA Philippines website for alerts, warnings and recalls," it added.