Adverse Reactions Due to Aquavene
Gorman and colleagues recently published a study regarding ureteral stents made of a novel poly(ethylene oxide)/polyurethane composite hydrogel (Aquavene). 1 Based on their encouraging in vitro results, the authors wrote, ''Aquavene is a promising candidate for use in the urinary tract . . . '' and ''Clinical evaluation of this biomaterial therefore appears to be warranted.'' Unfortunately, there was an important omission from the article: namely, that use of intravascular catheters made of this particular composite hydrogel has caused lethal anaphylactoid reactions! [2][3][4][5][6][7] In the first large propsective study of a device containing Aquavene, 3 of 238 patients suffered anaphylactoid reactions. 5 One in four adverse reactions associated with use of these Aquavene catheters (Landmark Midline catheters) reported to the Food and Drug Administration (FDA) from 1990 to 1994 were severe: cardiac arrest, spontaneous abortion, angioedema, or seizures. 5 After the prospective study was published, the manufacturer sent out a warning letter on January 12, 1996 admitting to ''rare life-threatening incidents associated with this device including cardiac arrest and three reports of respiratory arrest.'' This was followed by an FDA warning letter regarding use of these catheters on February 8, 1996, noting that ''there have been seven reports of life-threatening incidents shortly after catheter placement: four cases of cardiac arrest and three cases of respiratory arrest.'' This was highlighted in the Lancet. 8 A report on this issue from the Centers for Disease Control and Prevention was also published. 9 On September 18, 1996, all intravascular catheters made of Aquavene were quietly withdrawn from the U.S. market. 10 It is disquieting, if not unconscionable, for the manufacturer of Aquavene to now go outside of the United States to study this biomaterial and to suggest ''clinical evaluation'' for use in the urinary tract, 1 despite reports of death associated with intravascular catheters made of the same material. In a review of the FDA's Device Experience Network Database and Health Hazard Evaluations since 1986, there were no unanticipated adverse events associated with intravascular catheter insertion per 1.5 billion catheters made of other mate-rials compared with 190 such reactions per 726,000 Landmark midline catheters made of Aquavene. 11 The association of Aquavene with these adverse reactions is incontrovertible. The readers of this journal deserve to know the potential benefit and harm associated with Aquavene and any other future biomaterials intended for human use.