Adverse reactions : תופעות לוואי

ADVERSE REACTIONS
Fatalities from skin testing in the United States have been extensively reviewed by Lockey. 2 Six fatalities were associated with intradermal testing without previous percutaneous testing, and one was associated with a combination of percutaneous (scratch) and intradermal skin testing. With careful attention to dosage and administration, fatal reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and overdosage could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts for skin testing understand, and be prepared for the treatment of severe reactions.
Local: Immediate wheal and erythema reactions are to be expected; but if very large, may be the first manifestation of a systemic reaction.
In such cases, immediately wipe the test site(s) with sterile gauze or cotton to remove excess allergen.
Systemic Reactions: Systemic reactions are characterized by one or more of the following symptoms: sneezing, mild to severe generalized urticaria, itching (other than at the skin test site), extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, hypotension, syncope, and upper airway obstruction. Symptoms may progress to shock and death. Patients should always be observed for at least 20 - 30 minutes after testing.
Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalational bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. Severe airway obstruction unresponsive to bronchodilator may require tracheal intubation and use of oxygen. In the event of a marked systemic reaction, application of a tourniquet above the injection site and the administration of 0.2 mL to 1.0 mL of epinephrine injection (1:1,000) is recommended. Maximum recommended dose for children between 2 and 12 years of age is 0.3 mL. The tourniquet should not be left in place without loosening for 90 seconds every 15 minutes.
Adverse events should be reported via MedWatch (1-800-FDA-1088), Adverse Event Reporting, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787.