Amid a shortage of standard-of-care chemotherapy drugs, Sagent Pharmaceuticals is pulling two lots of its docetaxel injection from U.S. shelves after receiving a report of potential particulate matter in a vial.
The recalled batches were distributed nationwide between October 2023 and April 2024 and are set to expire this December. Customers are being alerted by way of a FedEx package that includes instructions and necessary arrangements for the return of the product, according to an FDA notice.
Intravenous injection of a product that contains particulate matter poses serious health risks. So far, Sagent has not received word of any adverse events related to the recalled product.
Docetaxel is a generic chemotherapy used to treat a number of cancer types. Various doses of the drug already face shortages in the U.S., according to the American Society of Health-System Pharmacists (ASHP).
The FDA does not list a docetaxel shortage in its own database. Some docetaxel offerings from Mylan, Pfizer, Baxter, Sagent, Sandoz and Winthrop, among others, are still available, ASHP notes.
Back in September, Becker’s Hospital Review reported a shortage encompassing three-fourths of the U.S. docetaxel supply.
Doctors are recommended to weigh the available supply of the treatment before starting patients on a docetaxel-containing regimen, ASHP notes, as “no single agent” can be substituted for the chemo.
Generic chemotherapy shortages have run rampant for more than a year, prompting difficult choices for oncologists and increased danger for patients as supply is rationed. Alternative treatments can sometimes be “unconventional and unproven,” not to mention risky and extremely costly, the American Society of Clinical Oncologists (ASCO)’s chief medical officer Julie Gralow said in prepared testimony for a House hearing earlier this year.
The total number of U.S. drug shortages was at a record high in the first quarter, ASHP reported. The group was tracking 323 shortages at that time.