ADVERSE REACTIONS
Localized Reactions:
During or immediately after treatment with EMLA Cream on
intact skin, the skin at the site of treatment may develop
erythema or edema or may be the locus of abnormal sensation.
Rare cases of discrete purpuric or petechial reactions at the
application site have been reported. Rare cases of
hyperpigmentation following the use of EMLA Cream have been
reported. The relationship to EMLA Cream or the underlying
procedure has not been established. In clinical studies on
intact skin involving over 1,300 EMLA Cream-treated subjects,
one or more such local reactions were noted in 56% of
patients, and were generally mild and transient, resolving
spontaneously within 1 or 2 hours. There were no serious
reactions that were ascribed to EMLA Cream.
Two recent reports describe blistering on the foreskin in
neonates about to undergo circumcision. Both neonates received
1.0 g of EMLA Cream.
In patients treated with EMLA Cream on intact skin, local
effects observed in the trials included: paleness (pallor or
blanching) 37%, redness (erythema) 30%,
alterations in temperature sensations 7%, edema
6%, itching 2% and rash, less than 1%.
In clinical studies on genital mucous membranes involving
378 EMLA Cream-treated patients, one or more application site
reactions, usually mild and transient, were noted in 41%
of patients. The most common application site reactions were
redness (21%), burning sensation (17%) and edema
(10%).
Allergic Reactions:
Allergic and anaphylactoid reactions associated with
lidocaine or prilocaine can occur. They are characterized by
urticaria, angioedema, bronchospasm, and shock. If they occur
they should be managed by conventional means. The detection of
sensitivity by skin testing is of doubtful value.
Systemic (Dose Related) Reactions:
Systemic adverse reactions following appropriate use of
EMLA Cream are unlikely due to the small dose absorbed (see
Pharmacokinetics
subsection of
CLINICAL
PHARMACOLOGY
). Systemic adverse effects of
lidocaine and/or prilocaine are similar in nature to those
observed with other amide local anesthetic agents including CNS
excitation and/or depression (light-headedness, nervousness,
apprehension, euphoria, confusion, dizziness, drowsiness,
tinnitus, blurred or double vision, vomiting, sensations of
heat, cold or numbness, twitching, tremors, convulsions,
unconsciousness, respiratory depression and arrest). Excitatory
CNS reactions may be brief or not occur at all, in which case
the first manifestation may be drowsiness merging into
unconsciousness. Cardiovascular manifestations may include
bradycardia, hypotension and cardiovascular collapse leading to
arrest.
|
REPORTS OF SUSPECTED EMLA SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Emla. The information is not vetted and should not be considered as verified clinical evidence.
Possible Emla side effects / adverse reactions in 22 month old female
Reported by a physician from France on 2011-10-27
Patient: 22 month old female
Reactions: Skin Burning Sensation, Intentional Drug Misuse
Adverse event resulted in: hospitalization
Suspect drug(s):
Emla
Possible Emla side effects / adverse reactions in 43 year old female
Reported by a physician from Russian Federation on 2011-10-28
Patient: 43 year old female
Reactions: Hypersensitivity, Counterfeit Drug Administered, Cyclitis, Uveitis, Keratitis
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Emla
Possible Emla side effects / adverse reactions in 36 year old male
Reported by a physician from Spain on 2012-02-20
Patient: 36 year old male
Reactions: Methaemoglobinaemia, Somnolence, Paraesthesia
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Emla
Other drugs received by patient: Ciprofloxacin HCL
|
