FDA strengthens Trasylol warning
Link to Article: FDA strengthens Trasylol warning
Posted in: Trasylol
Source | Associated Press
WASHINGTON - The government strengthened warnings on a drug commonly used to lessen blood loss during heart bypass surgery, saying yesterday that doctors should reserve Trasylol for higher-risk patients.
The Food and Drug Administration began re-evaluating the safety of Trasylol, also called aprotinin, last January after studies raised the possibility of kidney failure, heart attacks and strokes after its use.
Yesterday, the FDA strengthened the drug’s label to:
• Specify that Trasylol be given only to patients at increased risk of blood loss during the surgery.
• Warn that Trasylol increases the risk of kidney damage.
• Suggest ways to lower patients’ risk for a life-threatening allergic reaction, and treat them if one occurs.
The FDA still is probing the drug’s potential cardiovascular risks, and left open the possibility of further warnings.
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