"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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Fatal Cardiac Arrest, Ventricular Arrhythmias, And Myocardial Infarction
Fatal and nonfatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and myocardial infarction have occurred following Adenoscan infusion. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example, unstable angina or cardiovascular instability; these patients may be at greater risk of serious cardiovascular reactions to Adenoscan. Appropriate resuscitative measures should be available.
Sinoatrial And Atrioventricular Nodal Block
Adenoscan (adenosine injection) exerts a direct depressant effect on the SA and AV nodes and has the potential to cause first-, second- or third-degree AV block, or sinus bradycardia. Approximately 6.3% of patients develop AV block with Adenoscan, including first-degree (2.9%), second-degree (2.6%), and third-degree (0.8%) heart block. Adenoscan can cause sinus bradycardia. Adenoscan should be used with caution in patients with pre-existing first-degree AV block or bundle branch block and should be avoided in patients with high-grade AV block or sinus node dysfunction (except in patients with a functioning artificial pacemaker). Adenoscan should be discontinued in any patient who develops persistent or symptomatic high-grade AV block. Sinus pause has been rarely observed with adenosine infusions.
Adenoscan (adenosine injection) is a potent peripheral vasodilator and can cause significant hypotension. Patients with an intact baroreceptor reflex mechanism are able to maintain blood pressure and tissue perfusion in response to Adenoscan by increasing heart rate and cardiac output. However, Adenoscan should be used with caution in patients with autonomic dysfunction, stenotic valvular heart disease, pericarditis or pericardial effusions, stenotic carotid artery disease with cerebrovascular insufficiency, or uncorrected hypovolemia, due to the risk of hypotensive complications in these patients. Adenoscan should be discontinued in any patient who develops persistent or symptomatic hypotension.
Increases in systolic and diastolic pressure have been observed (as great as 140 mm Hg systolic in one case) concomitant with Adenoscan infusion; most increases resolved spontaneously within several minutes, but in some cases, hypertension lasted for several hours.
Adenoscan (adenosine injection) is a respiratory stimulant (probably through activation of carotid body chemoreceptors) and intravenous administration in man has been shown to increase minute ventilation (Ve) and reduce arterial PCO2 causing respiratory alkalosis. Approximately 28% of patients experience breathlessness (dyspnea) or an urge to breathe deeply with Adenoscan. These respiratory complaints are transient and only rarely require intervention.
Adenosine administered by inhalation has been reported to cause bronchoconstriction in asthmatic patients, presumably due to mast cell degranulation and histamine release. These effects have not been observed in normal subjects. Adenoscan has been administered to a limited number of patients with asthma and mild to moderate exacerbation of their symptoms has been reported. Respiratory compromise has occurred during adenosine infusion in patients with obstructive pulmonary disease. Adenoscan should be used with caution in patients with obstructive lung disease not associated with bronchoconstriction (e.g., emphysema, bronchitis, etc.) and should be avoided in patients with bronchoconstriction or bronchospasm (e.g., asthma). Adenoscan should be discontinued in any patient who develops severe respiratory difficulties.
Atrial fibrillation has been reported in patients (with and without a history of atrial fibrillation) undergoing myocardial perfusion imaging with adenosine infusion. In these cases, atrial fibrillation began 1.5 to 3 minutes after initiation of adenosine, lasted for 15 seconds to 6 hours, and spontaneously converted to normal sinus rhythm.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Studies in animals have not been performed to evaluate the carcinogenic potential of Adenoscan (adenosine injection). Adenosine was negative for genotoxic potential in the Salmonella (Ames Test) and Mammalian Microsome Assay.
Adenosine, however, like other nucleosides at millimolar concentrations present for several doubling times of cells in culture, is known to produce a variety of chromosomal alterations. Fertility studies in animals have not been conducted with adenosine.
Pregnancy Category C
Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. Because it is not known whether Adenoscan can cause fetal harm when administered to pregnant women, Adenoscan should be used during pregnancy only if clearly needed.
The safety and effectiveness of Adenoscan in patients less than 18 years of age have not been established.
Clinical studies of Adenoscan did not include sufficient numbers of subjects aged younger than 65 years to determine whether they respond differently. Other reported experience has not revealed clinically relevant differences of the response of elderly in comparison to younger patients. Greater sensitivity of some older individuals, however, cannot be ruled out.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/21/2014
Additional Adenoscan Information
- Adenoscan Drug Interactions Center: adenosine iv
- Adenoscan Side Effects Center
- Adenoscan FDA Approved Prescribing Information including Dosage
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