BETHESDA, MD, 16 Dec 2003—
The Food and Drug Administration (FDA) has awarded marketing approval to Bryan Corp.'s sterile talc powder for intrapleural administration in patients with recurrent malignant pleural effusion.
Malignant pleural effusion, a common complication of breast cancer, lung cancer, and lymphoma, occurs when the pleural space between the chest cavity and the outer membrane of the lung fills with fluid, preventing normal expansion of the lung. The administration of sterile talc powder, after drainage of the effusion, causes the outer lung membrane to adhere to the lining of the chest cavity, eliminating the pleural space and thus preventing reentry of fluid.
According to the product's FDA-approved labeling, sterile talc powder is supplied as 5 g of Talc, USP, in 100-mL brown glass bottles sealed with a stopper. The powder must be dissolved under sterile conditions with 50100 mL of sodium chloride injection, USP, to form a slurry, before administration through a chest tube into the drained pleural space.
The labeling includes step-by-step instructions for preparing the product for administration to patients.
According to the labeling, the administration of talc slurry can impede the later use of certain diagnostic procedures involving the affected lung. The sclerosing procedure can also complicate future lung transplantation or lung resection surgery.
The most common adverse events reported after administration of talc slurry were fever and pain. More serious adverse events included infection of the pleural cavity; respiratory complications, including pneumonia and pulmonary embolism; cardiovascular complications, including tachycardia and myocardial infarction; and adverse reactions related to insertion of the chest tube and delivery of the talc. The labeling notes that "it is difficult to distinguish the effects of talc from the effects of the procedure(s) associated with its administration."
Sterile talc powder was previously available from Bryan, but, in 2000, FDA declared the product an unapproved drug. The company subsequently submitted a new drug application, which FDA approved Monday. A company spokesman said the product is immediately available to hospitals.