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Imaging agent may cause cardiopulmonary failure.
Palatin Technologies, the manufacturer of NeutroSpec, is voluntarily suspending the sales and marketing of the radiodiagnostic agent in the United States, according to a public health advisory issued by the Food and Drug Administration. The action is being taken "pending review of reported and serious life-threatening adverse events associated with use of the product," according to the FDA.
NeutroSpec [Technetium (99m Tc) fanolesomab] an imaging agent comprising a murine IgM monoclonal antibody labeled with technetium, is approved for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are 5 years of age or older.
Two deaths attributed to cardiopulmonary failure within 30 minutes of injection have been reported, as have additional cases of serious events including cardiac arrest, hypoxia, dyspnea, and hypotension. Most of these adverse events occurred within minutes of injection and required patient resuscitation with fluids, vasopressors, and oxygen.
Although the majority of the reports involved patients receiving ...
- Cardiopulmonary failure linked to imaging agent.(News)
- Magazine article from: Skin & Allergy News Moon, Mary Ann February 1, 2006 700+ words
...life-threatening adverse events associated with...deaths attributed to cardiopulmonary failure within 30 minutes...Most of these adverse events occurred within...the agency said. Adverse events can be reported...
- Update: adverse events following civilian smallpox vaccination--United States,...
- Newspaper article from: Morbidity and Mortality Weekly Report February 13, 2004 700+ words
...information on vaccine-associated adverse events among civilians vaccinated since the...surveillance for vaccine-associated adverse events among civilian vaccinees (1,2...routine follow-up, and reported adverse events after vaccination receive follow...
- Smallpox vaccine adverse events among civilians -- United States, February...
- Newspaper article from: Morbidity and Mortality Weekly Report February 28, 2003 700+ words
...surveillance for vaccine-associated adverse events. In the first stage of the program...moderate-to-severe, and other serious adverse events and for vaccinia transmission to contacts...report summarizes smallpox vaccine adverse events reported among civilians vaccinated...
- Study provides first national estimate of adverse events in hospitals.
- Newspaper article from: Obesity, Fitness & Wellness Week June 26, 2004 700+ words
...result of their care. "The Canadian Adverse Events Study: the incidence of adverse events in hospital patients in Canada", published...Journal, found that the overall rate of adverse events in 2000 was 7.5 per 100 patient admissions...
- Smallpox vaccine adverse events monitoring and response system for the first...
- Newspaper article from: Morbidity and Mortality Weekly Report February 7, 2003 700+ words
...smallpox vaccination; no serious adverse events have been reported. To monitor the occurrence of adverse events associated with vaccination, both...experience and possible new unexpected adverse events, CDC and state health departments...
- Impact of patient communication problems on the risk of preventable adverse...
- Magazine article from: Canadian Medical Association. Journal Bartlett, Gillian; Blais, Régis; Tamblyn, Robyn; Clermont, Richard J; MacGibbon, Brenda June 3, 2008 700+ words
...ABSTRACT Background: Up to 50% of adverse events that occur in hospitals are preventable...with an increased risk of preventable adverse events. Methods: We randomly selected 20...cause and preventability of identified adverse events. The primary outcome was adverse ...
- Smallpox vaccine adverse events among civilians -- United States, January...
- Newspaper article from: Morbidity and Mortality Weekly Report February 21, 2003 700+ words
...surveillance for vaccine-associated adverse events. In the first stage of the program...moderate-to-severe, and other serious adverse events and for vaccine transmission to contacts...report summarizes smallpox vaccine adverse events reported among civilians vaccinated...
- Serious adverse events in academic critical care research
- Magazine article from: Canadian Medical Association. Journal Cook, Deborah; Lauzier, François; Rocha, Marcelo G; Sayles, Mary Jane; Finfer, Simon April 22, 2008 700+ words
...for defining and reporting serious adverse events that would be applicable to both academic...and transparent reporting of serious adverse events in randomized trials is crucial to...ideal system for reporting serious adverse events should encourage documentation of important...