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warnings and cautions
5 WARNINGS AND PRECAUTIONS Angioedema (e.g., swelling of the throat, head, and neck) can occur, and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue Pregabalin Capsules immediately in these cases. ( 5.1 ) Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue Pregabalin Capsules immediately in these patients. ( 5.2 ) Antiepileptic drugs, including pregabalin, the active ingredient in Pregabalin Capsules, 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 Pregabalin Capsules gradually over a minimum of 1 week. ( 5.4 ) Respiratory depression: May occur with Pregabalin Capsules, when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate. ( 5.5 ) Pregabalin Capsules may cause dizziness and somnolence and impair patients' ability to drive or operate machinery. ( 5.6 ) Pregabalin Capsules may cause peripheral edema. Exercise caution when co-administering Pregabalin Capsules and thiazolidinedione antidiabetic agents. ( 5.7 ) 5.1 Angioedema There have been postmarketing reports of angioedema in patients during initial and chronic treatment with Pregabalin Capsules. 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 Pregabalin Capsules immediately in patients with these symptoms. Exercise caution when prescribing Pregabalin Capsules 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 There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with Pregabalin Capsules. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue Pregabalin Capsules immediately in patients with these symptoms. 5.3 Suicidal Behavior and Ideation Antiepil...
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 serious adverse reactions are described elsewhere in the labeling: Angioedema [see Warnings and Precautions (5.1) ] Hypersensitivity [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) ] Tumorigenic Potential [see Warnings and Precautions (5.9) ] 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) ] PR Interval Prolongation [see Warnings and Precautions (5.13) ] Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention). ( 6.1 ) Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial-onset seizures are increased weight and increased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 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. In all controlled and uncontrolled trials across various patient populations during the premarketing development of Pregabalin Capsules, more than 10,000 patients have received Pregabalin Capsules. Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years. Adverse Reactions Most Commonly Leading to Discontinuation in All Premarketing Controlled Clinical Studies In premarketing controlled trials of all adult populations combined, 14% of patients treated with Pregabalin Capsules and 7% o...
adverse reactions table
Table 4. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Diabetic Peripheral NeuropathyBody system Preferred term 75 mg/day [N=77] % 150 mg/day [N=212] % 300 mg/day [N=321] % 600 mg/day [N=369] % All PGB PGB: pregabalin [N=979] % Placebo [N=459] % Body as a wholeAsthenia424752Accidental injury522643Back pain021220Chest pain411221Face edema011210Digestive systemDry mouth325751Constipation024642Flatulence302321Metabolic and nutritional disordersPeripheral edema4691292Weight gain044640Edema024220Hypoglycemia132121Nervous systemDizziness892329215Somnolence461316123Neuropathy922543Ataxia612431Vertigo122431Confusion012321Euphoria003220Incoordination102220Thinking abnormal Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.101320Tremor111210Abnormal gait101310Amnesia310210Nervousness011110Respiratory systemDyspnea302221Special sensesBlurry vision Investigator term; summary level term is amblyopia313642Abnormal vision101110