Feb 7, 2011 - Recall of Drug that Eases Side Effects of Cisplatin Used in Mesothelioma Treatments
American Regent has initiated a voluntary recall of one lot of single doses, 10 mL vials of sodium thiosulfate 10% injection made by Luitpold Pharmaceuticals because of the presence of translucent glass particles. The recalled lot is number 0056. The lot was distributed to wholesalers and retailers nationwide throughout the United States. The glass particles are said to have a ”flaky appearance” and may cause “damage to the blood vessels in the lung, localized swelling, and granuloma formation” according to the press release regarding the recall issued by American Regent.
An explanation for how the glass particles got into the product is that glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers.
Sodium thiosulfate is a treatment for cyanide poisoning, but is also used to lessen the side effects of cisplatin chemotherapy. Cisplatin chemotherapy has been approved for and is used in conjunction with other chemical agents in the treatment of malignant mesothelioma. Side effects of cisplatin include nausea, vomiting, nerve damages, kidney damage, loss of appetite and diarrhea.
The recall was dated February 2, 2011. According to statements, American Regent is undertaking the recall “in consideration of the potential for safety issues if this lot of product is administered to patients.” Consumers, distributors and retailers that have the recalled product are urged to stop use, quarantine and return the product.
Back to Treatment Research Listing