Imaging Agent Tied to Complications
Palatin Technologies, manufacturer of NeutroSpec, is voluntarily suspending U.S. sales and marketing of the radiodiagnostic agent, according to a public health advisory issued by the Food and Drug Administration. The action was taken “pending review of reported and serious life-threatening adverse events associated with use of the product,” the FDA said.
NeutroSpec [Technetium (99m Tc) fanolesomab], a murine IgM monoclonal antibody labeled with technetium, is approved for scintigraphic imaging of patients 5 years of age or older with equivocal signs and symptoms of appendicitis.
Two deaths attributed to cardiopulmonary failure within 30 minutes of injection have been reported, as have serious events including cardiac arrest, hypoxia, dyspnea, and hypotension. Most of the adverse events occurred within minutes of injection and required patient resuscitation with fluids, vasopressors, and oxygen. Most of the reports involved patients receiving NeutroSpec for unapproved indications, but “some patients who received the drug for [diagnosis of appendicitis] developed reactions of a similar nature,” the FDA said.
The FDA advisory recommended that health care providers discontinue use of NeutroSpec and contact the manufacturer about returning existing stocks.
Any patient given NeutroSpec despite the warning should be closely monitored for at least 1 hour, with access to resuscitation equipment and trained personnel. Patients with underlying cardiopulmonary conditions may be at higher risk for serious complications, the FDA said.
Adverse events can be reported to the manufacturer or directly to the FDA MedWatch reporting system by calling 800-332-1088 or by faxing 800-332-0178.
Blacks Have Worse Outcomes After ACS
Black patients with acute coronary syndrome face worse angina, physical impairment, and quality of life 1 year later than their white counterparts, reported Dr. John Spertus of Mid America Heart Institute of Saint Luke's Hospital, Kansas City, Mo., and his associates.
Researchers have documented racial disparities in ACS treatment and have found that these disparities have little impact on mortality outcomes. But no studies have assessed racial differences in symptoms, function, or quality of life after ACS treatment, Dr. Spertus and his associates said (J. Am. Coll. Cardiol. 2005:46:1838-44).
They evaluated outcomes using a database on nearly 11,000 consecutive patients treated at two Kansas City hospitals in 2001-2002. At 1-year follow-up, black ACS patients were 46% more likely than whites to have residual angina, and they had more frequent bouts of angina. Blacks also had poorer physical function and worse quality of life than did whites; 52% of blacks reported some degree of limitation, compared with only 29% of whites.
As in previous studies, black patients were much less likely than white patients to undergo primary or secondary percutaneous coronary intervention, to undergo diagnostic angiography, or to have bypass surgery. Yet these treatment disparities did not fully account for the racial differences in outcomes. “Other factors in the care of patients between discharge and 1 year may be responsible,” the investigators noted.
Until further research addresses underlying causes, “greater surveillance of the health status of black patients appears warranted so that those who are symptomatic, physically limited, or suffering a significant impairment in their quality of life can be identified and reevaluated for further treatment options,” they added.
HCM Diagnosed Later in Women
Hypertrophic cardiomyopathy is diagnosed later in women than in men, and is more likely to progress to severe, disabling symptoms or death, reported Dr. Iacopo Olivotto of Azienda Ospedaliera Universitaria Careggi, Florence, Italy, and associates.
Both findings “underscore the importance of heightened suspicion for HCM in women,” the researchers said (J. Am. Coll. Cardiol. 2005;46:480-7).
They assessed disease progression over an average of 6 years in 969 consecutive patients treated for HCM at three medical centers in Italy and the United States. The 393 women were an average of 9 years older than the 576 men at diagnosis. Nearly 60% of the women had severe symptoms, including exertional dyspnea, chest pain, and syncope, compared with fewer than 40% of the men. Women were more likely to have left ventricular outflow obstruction, possibly because of the smaller dimensions of their left ventricular cavities.
Treatment was equivalent for men and women once diagnosed, but women were much more likely to show symptomatic progression and to die from heart failure or embolic stroke. This was due in part to the delay in diagnosis and treatment, but the data suggest that some other, as yet unknown, mechanism related to female gender may make women more prone to HCM progression, the researchers said.