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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Angioedema : Angioedema [e.g., swelling of the face, mouth (tongue, lips, and gums) and neck (throat and larynx)] can occur and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue LYRICA CR immediately in patients with these symptoms. ( 5.1 ) • Hypersensitivity Reactions : Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue LYRICA CR immediately in these patients. ( 5.2 ) • Suicidal Behavior and Ideation : Antiepileptic drugs, including pregabalin, the active ingredient in LYRICA CR, increase the risk of suicidal thoughts or behavior. ( 5.3 ) • Abrupt or rapid discontinuation may increase the risk for seizures. Withdrawal symptoms or suicidal behavior and ideation have been observed after discontinuation. Taper LYRICA CR gradually over a minimum of 1 week. ( 5.4 ) • Respiratory Depression : May occur with LYRICA when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate. ( 5.5 ) • Dizziness and Somnolence : May cause dizziness and somnolence and impair patient’s ability to drive or operate machinery. ( 5.6 ) • Peripheral Edema : May cause peripheral edema. Monitor patients for the development of edema when co-administering LYRICA CR and thiazolidinedione antidiabetic agents. ( 5.7 ) 5.1 Angioedema 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. Discontinue LYRICA CR immediately in patients with these symptoms. Exercise caution when prescribing LYRICA CR to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema. 5.2 Hypersensitivity Reactions There have been postmarketing reports of hypersensitivity reactions in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA CR imme...
warnings and cautions table
Table 3. Risk by Indication for Antiepileptic Drugs in the Pooled AnalysisIndicationPlacebo Patients With Events per 1000 PatientsDrug Patients With Events per 1000 PatientsRelative Risk: Incidence of Events in Drug Patients/Incidence in Placebo PatientsRisk Difference: Additional Drug Patients With Events per 1000 PatientsEpilepsy1.03.43.52.4Psychiatric5.78.51.52.9Other1.01.81.90.9Total2.44.31.81.9
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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Angioedema [see Warnings and Precautions (5.1) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.3) ] • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.4) ] • Respiratory Depression [see Warnings and Precautions (5.5) ] • Dizziness and Somnolence [see Warnings and Precautions (5.6) ] • Peripheral Edema [see Warnings and Precautions (5.7) ] • Weight Gain [see Warnings and Precautions (5.8) ] • Ophthalmological Effects [see Warnings and Precautions (5.10) ] • Creatine Kinase Elevations [see Warnings and Precautions (5.11) ] • Decreased Platelet Count [see Warnings and Precautions (5.12) ] Most common adverse reactions reported in greater than or equal to 4% of patients treated with LYRICA CR are dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Two randomized placebo-controlled clinical trials were conducted in patients with postherpetic neuralgia and fibromyalgia in which a total of 1242 patients received LYRICA CR. Both studies were randomized withdrawal design where a 6-week single-blind, dose optimization phase was followed by a 13-week double-blind phase. The most common adverse events leading to discontinuation from the single-blind phase of the study occurring in greater than or equal to 0.3% of patients were dizziness, somnolence, peripheral edema, fatigue, blurred vision, and increased weight. Sixty-four percent of patients experienced adverse events during the single-blind phase, with the most common adverse events occurring in greater than or equal to 4% of patients being dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain. Controlled Study in Postherpetic Ne...
adverse reactions table
Table 4. Incidence of Adverse Reactions Reported in Greater Than or Equal to 1% of Subjects in Any Phase of the LYRICA CR Study in Patients with Postherpetic Neuralgia* * Table is limited to adverse reactions that occurred with higher incidence in LYRICA CR-treated patients than in placebo-treated patients for the DB Phase of the study.System Organ Class Preferred TermSingle-Blind PhaseDouble-Blind PhaseLYRICA CR [N=801] n (%)LYRICA CR [N=208] n (%)Placebo [N=205] n (%)Ear and labyrinth disorders Vertigo31 (3.9)2 (1.0)1 (0.5)Eye disorders Vision blurred30 (3.7)1 (0.5)0 Diplopia8 (1.0)1 (0.5)0Gastrointestinal disorders Dry mouth30 (3.7)1 (0.5)0 Nausea24 (3.0)7 (3.4)0 Constipation22 (2.7)00 Diarrhea11 (1.4)2 (1.0)1 (0.5) Vomiting9 (1.1)3 (1.4)1 (0.5)General disorders and administration site conditions Edema peripheral39 (4.9)8 (3.8)1 (0.5) Fatigue31 (3.9)3 (1.4)2 (1.0) Edema3 (0.4)3 (1.4)0Infections and infestations Nasopharyngitis12 (1.5)3 (1.4)0 Urinary tract infection11 (1.4)3 (1.4)1 (0.5) Bronchitis4 (0.5)3 (1.4)2 (1.0) Respiratory tract infection viral3 (0.4)3 (1.4)1 (0.5) Sinusitis3 (0.4)2 (1.0)0 Gastroenteritis viral2 (0.2)2 (1.0)0Investigations Weight increased20 (2.5)8 (3.8)2 (1.0) Alanine aminotransferase increased2 (0.2)3 (1.4)0 Aspartate aminotransferase increased2 (0.2)2 (1.0)0Musculoskeletal and connective tissue disorders Arthralgia6 (0.7)2 (1.0)1 (0.5) Joint swelling04 (1.9)0