Important Safety Information
LYRICA is contraindicated in patients with known hypersensitivity to pregabalin
or any of its other components. There have been postmarketing reports of hypersensitivity
in patients shortly after initiation of treatment with LYRICA. Adverse reactions included
skin redness, blisters, hives, rash, dyspnea, and wheezing. LYRICA should be discontinued
immediately in patients with these symptoms.
There have been postmarketing reports of angioedema in patients during initial and chronic treatment
with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums),
and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory
compromise requiring emergency treatment. LYRICA should be discontinued immediately in patients
with these symptoms.
Antiepileptic drugs increase the risk of suicidal thoughts or behavior. Like other antiepileptic drugs,
LYRICA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or
behavior, and/or any unusual changes in mood or behavior.
The most common adverse reactions are dizziness, somnolence, dry mouth, edema, blurred vision,
weight gain, constipation, euphoric mood, balance disorder, increased appetite,
and thinking abnormal (primarily difficulty with concentration/attention.)
Patients taking LYRICA should be counseled that dizziness and somnolence may impair
their ability to perform potentially hazardous tasks such as driving or operating
complex machinery until they have sufficient experience with LYRICA to determine
its effect on cognitive and motor function.
In controlled studies, a higher proportion of patients treated with LYRICA reported blurred
vision (7%) than did patients treated with placebo (2%), which resolved in a majority of
cases with continued dosing. More frequent assessment should be considered for patients
who are already routinely monitored for ocular conditions.
Higher frequency of weight gain and edema was observed in patients taking both LYRICA
and thiazolidinedione antidiabetic drugs. Caution should be exercised when coadministering these
drugs. Patients who are taking other drugs associated with angioedema such as angiotensin-converting
enzyme inhibitors (ACE inhibitors) may be at increased risk of developing angioedema. LYRICA should
be used with caution in patients who have had a previous episode of angioedema.
LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor
functioning.
Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.
LYRICA should be discontinued gradually over a minimum of 1 week.
LYRICA should be discontinued immediately in patients with symptoms of hypersensitivity or angioedema.
Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to
adverse reactions than patients with normal creatinine clearance. Dosage adjustment is recommended
for patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing
hemodialysis. A supplemental dose of LYRICA should be given immediately following every 4-hour
hemodialysis treatment.
In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high
incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical
significance of this finding is unknown. Clinical experience during LYRICA’s premarketing
development provides no direct means to assess its potential for inducing tumors in humans.
In clinical studies across various patient populations comprising 6396 patient-years of exposure in
patients >12 years of age, new or worsening preexisting tumors were reported in 57 patients. Without
knowledge of the background incidence and recurrence in similar populations not treated with LYRICA,
it is impossible to know whether the incidence seen in these cohorts is or is not affected by treatment.
A dose-dependent increase in the incidence of hemangiosarcomas was observed in 2 strains of mice given LYRICA
for 2 years. Plasma LYRICA exposure (AUC) in mice receiving the lowest dose that increased hemangiosarcomas
was approximately equal to the human exposure of 600 mg/day. A no-effect dose for induction of hemangiosarcomas
in mice was not established. No evidence of carcinogenicity was seen in 2 studies in Wistar rats following
dietary administration of LYRICA for 2 years at doses that were associated with plasma exposures up to 24
times human exposure.
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