Particulate contamination of injectable drugs isn’t just a hindrance for manufacturers and customers: it can pose serious health risks, too. And when those drugs are intended for cancer patients, the glitch becomes even more concerning.
Teva Pharmaceutical is pulling one lot of its injectable leukemia med IDArubicin hydrochloride in the U.S. after an internal inspection uncovered silica and iron oxide particulate matter in a lone drug vial, the company said in a recall notice published on the FDA’s website. The defect hasn’t turned up in any other vials, Teva added.
IDArubicin hydrochloride injection is used in tandem with other meds to treat adults with acute myeloid leukemia. Side effects from injecting a product tainted with particulate matter can be as mild as local irritation or swelling. But if the particulate matter reaches the blood vessels, it can travel to various organs and block blood vessels in the heart, lungs or brain, potentially leading to stroke or even death, Teva said.
The company shipped the drug out nationwide between Dec. 4, 2020, and Aug. 18, 2021.
Teva faced a similar ordeal last summer, when it recalled one lot of the cancer med topotecan injection. In that instance, a pharmacy complaint tipped off the company to the presence of a single glass particulate in a vial of the drug. After a sample review, Teva said it turned up two other particles, which it identified as grey silicone and “translucent, colorless cotton fiber.”
Particulate pollution recently struck Fresenius Kabi, too. Earlier this month, the company yanked seven lots of sodium acetate intravenous fluid in the U.S. because testing revealed particulates of carbon and oxygen with traces of sodium silicon, chromium, aluminum and cellulose.
Elsewhere, particulates have presaged major problems for Gilead Sciences in recent months. In December, the Foster City, California-based drugmaker said it was recalling two batches of the COVID-19 antiviral Veklury, also known as remdesivir. Much like Teva’s topotecan pull, a customer complaint flagged the presence of glass particulates, which Gilead then confirmed through its own investigation.
Later that same month, the FDA slapped a clinical hold on 10 studies of Gilead’s injectable HIV prospect lenacapavir, citing concerns about the compatibility of the solution with the borosilicate vials it’s stored in. Gilead flagged the risk that the borosilicate vials could interact with the drug to create “sub-visible” glass particles.
Those vial compatibility concerns caused lenacapavir to receive a Complete Response Letter from the FDA in March.
“While the health hazard risk could be severe if particulate matter is infused, Teva’s internal health assessment determined that the likelihood of patient harm is remote or unlikely,” the company said.
As of Tuesday, Teva said it hadn’t received any quality complaints or side effect reports linked to the suspect lot.
The cancer med comes in 5-ml single-dose vials, of which Teva distributed 1,565 from the affected lot.