ADVERTISEMENT
Manila Bulletin devider Philippines devider National devider FDA warns about 'contamination' in a certain cancer treatment solution

FDA warns about 'contamination' in a certain cancer treatment solution

Published Mar 18, 2024 03:12 am

The Food and Drug Administration (FDA) issued a warning on Monday, March 18, urging hospitals, healthcare facilities, professionals, and the general public to cease the use of Methotrexate 100 milligram/milliliter (mg/ml) solution for intramuscular (IM) and intravenous (IV) injections.

FDA.png
Photo from FDA Facebook page

It explained that methotrexate, which is manufactured by Bruck Pharma Private Limited, India, and distributed by Nelpa Life Sciences, Inc. in the country, serves as a crucial treatment for cancer and other severe illnesses that do not respond to regular medications.

However, the FDA found a big problem with contamination in a batch of the drug with the code I23J001A and confirmed that it has "Pseudomonas aeruginosa," a harmful bacteria.

It highlighted that the infection with Pseudomonas aeruginosa in the bloodstream can be really serious, even causing death.

The agency also pointed out that when giving this drug to patients with weakened immune systems, it's important to have really careful quality checks to stop any contamination problems.

Given the gravity of the situation, the FDA mandated an immediate stop to the use and dispensing of all available batches until further notice.

It underscored the importance of drug establishments implementing rigorous risk management plans and promptly addressing safety breaches.

Moreover, the agency is actively investigating the accountability of drug establishments in ensuring product quality and safety, with penalties upcoming where warranted.

Related Tags

contamination FDA
ADVERTISEMENT
.most-popular .layout-ratio{ padding-bottom: 79.13%; } @media (min-width: 768px) and (max-width: 1024px) { .widget-title { font-size: 15px !important; } }

{{ articles_filter_1561_widget.title }}

{{ item.title }}
.most-popular .layout-ratio{ padding-bottom: 79.13%; } @media (min-width: 768px) and (max-width: 1024px) { .widget-title { font-size: 15px !important; } }

{{ articles_filter_1562_widget.title }}

{{ item.title }}
.most-popular .layout-ratio{ padding-bottom: 79.13%; } @media (min-width: 768px) and (max-width: 1024px) { .widget-title { font-size: 15px !important; } }

{{ articles_filter_1563_widget.title }}

{{ item.title }}

{{ articles_filter_1564_widget.title }}

{{ item.title }}
.mb-article-details { position: relative; } .mb-article-details .article-body-preview, .mb-article-details .article-body-summary{ font-size: 17px; line-height: 30px; font-family: "Libre Caslon Text", serif; color: #000; } .mb-article-details .article-body-preview iframe , .mb-article-details .article-body-summary iframe{ width: 100%; margin: auto; } .read-more-background { background: linear-gradient(180deg, color(display-p3 1.000 1.000 1.000 / 0) 13.75%, color(display-p3 1.000 1.000 1.000 / 0.8) 30.79%, color(display-p3 1.000 1.000 1.000) 72.5%); position: absolute; height: 200px; width: 100%; bottom: 0; display: flex; justify-content: center; align-items: center; padding: 0; } .read-more-background a{ color: #000; } .read-more-btn { padding: 17px 45px; font-family: Inter; font-weight: 700; font-size: 18px; line-height: 16px; text-align: center; vertical-align: middle; border: 1px solid black; background-color: white; } .hidden { display: none; }
function initializeAllSwipers() { // Get all hidden inputs with cms_article_id document.querySelectorAll('[id^="cms_article_id_"]').forEach(function (input) { const cmsArticleId = input.value; const articleSelector = '#article-' + cmsArticleId + ' .body_images'; const swiperElement = document.querySelector(articleSelector); if (swiperElement && !swiperElement.classList.contains('swiper-initialized')) { new Swiper(articleSelector, { loop: true, pagination: false, navigation: { nextEl: '#article-' + cmsArticleId + ' .swiper-button-next', prevEl: '#article-' + cmsArticleId + ' .swiper-button-prev', }, }); } }); } setTimeout(initializeAllSwipers, 3000); const intersectionObserver = new IntersectionObserver( (entries) => { entries.forEach((entry) => { if (entry.isIntersecting) { const newUrl = entry.target.getAttribute("data-url"); if (newUrl) { history.pushState(null, null, newUrl); let article = entry.target; // Extract metadata const author = article.querySelector('.author-section').textContent.replace('By', '').trim(); const section = article.querySelector('.section-info ').textContent.replace(' ', ' '); const title = article.querySelector('.article-title h1').textContent; // Parse URL for Chartbeat path format const parsedUrl = new URL(newUrl, window.location.origin); const cleanUrl = parsedUrl.host + parsedUrl.pathname; // Update Chartbeat configuration if (typeof window._sf_async_config !== 'undefined') { window._sf_async_config.path = cleanUrl; window._sf_async_config.sections = section; window._sf_async_config.authors = author; } // Track virtual page view with Chartbeat if (typeof pSUPERFLY !== 'undefined' && typeof pSUPERFLY.virtualPage === 'function') { try { pSUPERFLY.virtualPage({ path: cleanUrl, title: title, sections: section, authors: author }); } catch (error) { console.error('ping error', error); } } // Optional: Update document title if (title && title !== document.title) { document.title = title; } } } }); }, { threshold: 0.1 } ); function showArticleBody(button) { const article = button.closest("article"); const summary = article.querySelector(".article-body-summary"); const body = article.querySelector(".article-body-preview"); const readMoreSection = article.querySelector(".read-more-background"); // Hide summary and read-more section summary.style.display = "none"; readMoreSection.style.display = "none"; // Show the full article body body.classList.remove("hidden"); } document.addEventListener("DOMContentLoaded", () => { let loadCount = 0; // Track how many times articles are loaded const offset = [1, 2, 3, 4, 5, 6, 7, 8, 9, 10]; // Offset values const currentUrl = window.location.pathname.substring(1); let isLoading = false; // Prevent multiple calls if (!currentUrl) { console.log("Current URL is invalid."); return; } const sentinel = document.getElementById("load-more-sentinel"); if (!sentinel) { console.log("Sentinel element not found."); return; } function isSentinelVisible() { const rect = sentinel.getBoundingClientRect(); return ( rect.top < window.innerHeight && rect.bottom >= 0 ); } function onScroll() { if (isLoading) return; if (isSentinelVisible()) { if (loadCount >= offset.length) { console.log("Maximum load attempts reached."); window.removeEventListener("scroll", onScroll); return; } isLoading = true; const currentOffset = offset[loadCount]; window.loadMoreItems().then(() => { let article = document.querySelector('#widget_1690 > div:nth-last-of-type(2) article'); intersectionObserver.observe(article) loadCount++; }).catch(error => { console.error("Error loading more items:", error); }).finally(() => { isLoading = false; }); } } window.addEventListener("scroll", onScroll); });
Join Our Newsletters

Sign up by email to receive news.

© 2025 Manila Bulletin The Nation's Leading Newspaper. All Rights Reserved.