FDA orders recall of chemotherapy injectable
MONITORING | The Food and Drug Administration has stepped up its monitoring of the sale of food and drugs that may be harmful to consumers and patients. (Photo by MARIANNE BERMUDEZ / Philippine Daily Inquirer)
MANILA, Philippines — The Food and Drug Administration (FDA) has issued an advisory ordering the recall of a chemotherapy injectable found to be contaminated with bacteria that cause fatal infections.
In its Advisory No. 2024-0532, the agency warned against the sale and use of Trexasaph (generic name: Methotrexate), regardless of its batch manufacturing, after the imported drug with Batch No. I23J001A 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 advisory signed by FDA Director General Dr. Samuel Zacate said of the 100 mg/mL solution injectable. It also directed all government and private drug retail outlets to stop dispensing the drug.
P. aeruginosa is commonly contracted by patients who have been hospitalized for longer than a week. It can cause bloodstream infection (sepsis), which may lead to death. Thus, any product that has any contamination by P. aeruginosa and is administered directly to the body would present serious risks to patients.
The bacteria can grow and spread through water (from sinks, bathtubs, pools, hot tubs, humidifiers and kitchens), soil, and contaminated food and medical devices, such as ventilators and urinary catheters.
P. aeruginosa infection can also pass from person to person, usually from contaminated surfaces or hands.
Report use, sale of drug
Based on the FDA’s database, Trexasaph is manufactured by India-based Bruck Pharma Private Ltd., and imported by Nelpa Life Sciences Inc. in Parañaque City. Its registration with the agency in 2022 is due to expire in May 2027.
The FDA said drug establishments distributing the product were now “required” to implement their risk management plans, monitor the product’s safety profile, and take immediate action when there is probable cause of safety breaches.
But the agency also noted: “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.”
Methotrexate is a chemotherapy agent and immune system suppressant. It is used to treat neoplastic diseases such as trophoblastic neoplasms (tumors) and leukemia and to symptomatically treat recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy.
READ: Traditional chemo, targeted therapy: What’s the difference?
Patients receiving methotrexate treatment may develop opportunistic infections (OIs), which occur among patients with weakened immune systems.
Consumers may contact Nelpa Life Sciences, importer of Trexasaph, through email at [email protected].
The public may also report to the FDA the continuous sale or distribution of Trexasaph through [email protected], or they may call the FDA’s Center for Drug Regulation and Research at (02) 8809-5596.
Any suspected adverse reaction to this product should be reported to the FDA through this link, and all the required fields should be filled out.
FDA now requires prescription
Earlier, the FDA issued two separate circulars recalling and withdrawing the classification and registration of domperidone and topical corticosteroids as over-the-counter drugs.
The regulator reclassified domperidone, a drug used to treat dyspepsia or indigestion, as well as nausea and vomiting, as a prescription drug.
Topical corticosteroids, which have become a go-to remedy for the treatment of many skin ailments, now also need a prescription after it was found that the drug’s misuse could lead to more complicated skin disorders.
In February, the agency issued advisories warning the public about the risks of the use of these two drugs.
The FDA ordered all marketing authorization holders of domperidone and topical corticosteroids to recall the inventory of those products and update their labeling and packaging.
Packaging inserts
For domperidone, its packaging inserts under the Contraindications and Special Warnings and Precautions shall indicate that its use can cause an increased risk of cardiovascular effects.
“The [FDA] conducted [a] literature review to assess the safety of domperidone considering regulatory actions made by other countries in response to an epidemiological study showing that domperidone is associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death,” the agency said.
For topical corticosteroids, their packaging shall indicate that misuse will result in topical steroid withdrawal (TSW), also called topical steroid addiction or red skin syndrome.
Among the symptoms of TSW are redness of the skin, a burning sensation, followed by skin peeling, and a flare-up of the underlying condition.
This results from “prolonged, frequent, and inappropriate” use of moderate to high potency topical corticosteroids, especially on the face and genital area, the FDA said.
