MANILA, Philippines – The Philippine Food and Drug Administration (FDA) has issued a second recall order for the imported chemotherapy drug Trexasaph after more of its batches were found to be contaminated with bacteria that cause deadly infections.
By virtue of Notice no. 2024-0741 of the agency dated May 3, FDA Director General Dr. Samuel Zacate ordered the product recall of Trexasaph (generic name Methotrexate) 100 mg/mL solution for injection (IM/ IV) with lot no. I23F025A, I23J001A, I23K002A and I23H018A.
Methotrexate is a chemotherapy agent and immune system suppressant. It is used in the treatment of neoplastic diseases (cancers), such as trophoblastic neoplasms and leukemia, and the symptomatic treatment of disabling recalcitrant psoriasis, which does not respond adequately to other forms of therapy.
READ: FDA orders recall of chemotherapy injectables
Patients receiving treatment with methotrexate may have a weakened immune system and be more vulnerable to opportunistic infections.
“Following the report of adverse reactions received in a pediatric patient administered Trexasaph, the [FDA] laboratory analysis of the collected samples. The Trexasaph with batch no. I23J001A failed the sterility test and tested positive for Pseudomonas aeruginosa, indicating contamination of the products,” the FDA said.
P. aeruginosa is commonly contracted by patients who have been hospitalized for more than a week. It can cause infection of the bloodstream (sepsis), which can lead to death. Any product that has any contamination and is administered directly into the body poses serious risks to patients.
Bacteria can grow and spread in many different ways, including through water (from sinks, bathtubs, pools, hot tubs, humidifiers, and kitchens), soil, food, and contaminated medical devices (such as ventilators or urinary catheters).
P. aeruginosa infection can be spread from person to person, usually from contaminated surfaces or hands.
“Areas of Jurisdiction”
The regulator ordered distributors, hospitals, retailers, pharmacies and clinics to stop distributing, selling and using Trexasaph.
Consumers are also advised not to use or purchase the affected products.
“All local government units and law enforcement agencies are requested to ensure that the affected batch of product is not sold or made available in their localities or areas of jurisdiction,” the FDA noted.
Based on the FDA database, Trexasaph is manufactured by India-based Bruck Pharma Private Ltd. and imported by Nelpa Lifesciences Inc. in Parañaque City.
It has been registered with the FDA since May 2022 and its registration will expire in May 2027.
This is the second time this year that the FDA has issued a recall order against Trexasaph.
In March, the FDA issued an advisory warning all government and private healthcare facilities to stop the sale, dispensing and use of Trexasaph after a sample belonging to batch no. I23J001A was positive with P. aeruginosa.
To report the continued sale or distribution of affected lots of Trexasaph, the public can email the FDA at [email protected] or also call their Medicines Research and Regulation Center on telephone number (02) 8809-5596.
Scheepril remembered it too
The FDA also ordered a product recall of Scheepril (generic name Enalapril maleate) 10 mg tablet with lot no. 29080, to have a smaller amount of its active ingredient than indicated.
“The result of the laboratory analysis conducted by the FDA showed that the specific batch contains only 8.54 mg of Enalapril maleate per tablet,” Zacate said under FDA notice no. 2024-0740 of May 3.
Scheepril is manufactured by Scheele Laboratories Philippines Inc., based in Valenzuela City.
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Enalapril maleate is an angiotensin-converting enzyme inhibitor used in the treatment of hypertension (high blood pressure) to help prevent strokes, heart attacks and kidney problems.
It may also be given to patients with certain heart problems (including asymptomatic left ventricular dysfunction) to delay the development of heart failure and reduce the incidence of coronary ischemic events, including heart attack.
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