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Two additional deaths following medical abortion with mifepristone (Mifeprex) have prompted the Food and Drug Administration to issue a public health advisory alerting health care providers and advising review of the prescribing information.
The drug's manufacturer, Danco Laboratories, notified the agency of the deaths, which took place in the United States. The FDA is investigating the cases but cannot yet confirm the causes of death.
The agency advises physicians to discuss with their patients the risk of sepsis as well as early signs and symptoms that may warrant immediate medical evaluation. In addition, the FDA advises physicians and emergency department personnel to investigate the possibility of sepsis in patients who are undergoing medical abortion and present with nausea, vomiting, or diarrhea; weakness with or without abdominal pain; and ...
Source: HighBeam Research, Two more deaths may be connected to mifepristone use.(News)