FDA Safety Change – Lisinopril
Tablets (Prinivil) Linked Rarely to Head/Neck Angoiedema
and Hepatic Failure
Angioedema of the face, extremities, lips, tongue,
glottis, and/or larynx has been reported rarely in patients
treated with angiotensin-converting enzyme inhibitors,
such as lisinopril. This may occur at any time during
treatment and has occurred more frequently in black
patients compared with nonblack patients. Patients with
a history of angioedema unrelated to angiotensin-converting
enzyme inhibitor therapy also may be at increased risk.
Lisinopril therapy should be immediately discontinued
in patients presenting with angioedema; appropriate
antihistamine/corticosteroid therapy and monitoring
should be provided until complete and sustained resolution
of all signs and symptoms has occurred.
The FDA notes that even patients presenting with swelling
of the tongue only (in the absence of respiratory distress)
may require prolonged observation because treatment
may not be sufficient. Very rarely, airway obstruction
due to angioedema of the larynx or tongue has resulted
in fatality.
Patients with involvement of the tongue, glottis,
or larynx who are likely to experience airway obstruction
(especially those with a history of airway surgery)
should be treated with 0.3 to 0.5 mL subcutaneous 1:1000
epinephrine solution and/or other measures to ensure
patency.
Angiotensin-converting enzyme inhibitor therapy also
has been associated with a rare syndrome that initially
presents as cholestatic jaundice or hepatitis and progresses
to fulminant hepatic necrosis and sometimes death. Although
the mechanism of this syndrome is not understood, angiotensin-converting
enzyme inhibitors should be discontinued in patients
who develop jaundice or marked elevations of hepatic
enzymes.
Lisinopril tablets are indicated for the treatment of
hypertension; as adjunctive therapy for the treatment
of heart failure in patients who are not responding
adequately to diuretics and digitalis; and to improve
survival in hemodynamically stable patients within 24
hours of acute myocardial infarction.
Courtesy of "Medscape Medical News"
2006 |
