Ill-dissolving capsules can hamper drugs’ effectiveness or render them useless, which is especially concerning when they’re used to treat seriously sick blood disorder patients.
Teva Pharmaceuticals ran into just such a problem during routine stability testing of its thrombocythemia drug anagrelide. Thanks to a dissolution test failure—when med takes longer to dissolve once ingested—Teva is recalling one lot of 0.5-mg capsules in the U.S. No other batches are affected, the company added.
Taking a capsule that doesn't dissolve properly can curb or nullify the drug’s platelet-reducing effect, Teva warned in a notice on the FDA’s website.
Anagrelide capsules are FDA-cleared to treat thrombocythemia secondary to myeloproliferative neoplasms—a group of blood cancers rooted in the bone marrow. Specifically, thrombocythemia patients’ bodies produce too many platelets, which are the part of the blood that sticks together to form clots. This can result in bleeding or, more often, clotting, which puts patients at risk of heart attack or stroke.
Botched dissolution of anagrelide—designed to reduce platelet counts—could prompt a “slower rate and extent of drug release leading to less anagrelide available in the body,” Teva explained.
That in turn could cause patients to suffer the very clotting, bleeding, or clotting and bleeding events the drug is meant to stave off.
As of Monday, Teva said it hadn’t received any quality complaints or side effect reports for the suspect lot.
Teva’s med comes in 100-count bottles, of which the company deployed 4,224 across the U.S. between July 30 and Sept. 2 of 2020, Teva said. The batch in question was set to expire this month.
Meanwhile, this isn’t Teva’s first appearance on the FDA’s recall tally this year. Back in March, the company said it was yanking a solo batch of its injectable leukemia med IDArubicin hydrochloride after an internal inspection uncovered silica and iron oxide particulate matter in a lone drug vial.
Injecting a particulate-contaminated drug could lead to mild side effects like 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 at the time.
“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 noted in late March.