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warnings and cautions
5 WARNINGS AND PRECAUTIONS Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): discontinue if alternative etiology is not established (5.1) Anaphylaxis and Angioedema: discontinue and evaluate patient immediately (5.2) Driving Impairment; Somnolence/Sedation and Dizziness: warn patients not to drive until they have gained sufficient experience to assess whether their ability to drive or operate heavy machinery will be impaired (5.3, 5.4) Increased seizure frequency may occur in patients with seizure disorders if gabapentin oral solution is abruptly discontinued (5.5) Suicidal Behavior and Ideation: monitor for suicidal thoughts/behavior (5.6) Respiratory Depression: May occur with gabapentin oral solution when used with concomitant central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate (5.7) Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: monitor for such events (5.8) 5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with gabapentin oral solution. Some of these reactions have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Gabapentin oral solution should be discontinued if an alternative etiology for the signs or symptoms cannot be established. 5.2 Anaphylaxis and Angioedema Gabapentin oral solution can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotensi...
warnings and cautions table
IndicationPlacebo Patients with Events Per 1000 PatientsDrug Patients with Events Per 1000 PatientsRelative Risk: Incidence of Events in Drug Patients/ Incidencein 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 discussed in greater detail in other sections: • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.1)] • Anaphylaxis and Angioedema [see Warnings and Precautions (5.2)] • Somnolence/Sedation and Dizziness [see Warnings and Precautions (5.4)] • Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.5)] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.6)] • Respiratory Depression [see Warnings and Precautions (5.7)] • Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see Warnings and Precautions (5.8)] • Sudden and Unexplained Death in Patients with Epilepsy [see Warnings and Precautions (5.10)] Most common adverse reactions (incidence ≥8% and at least twice that for placebo) were: Postherpetic neuralgia: dizziness, somnolence, and peripheral edema (6.1) Epilepsy in patients >12 years of age: somnolence, dizziness, ataxia, fatigue, and nystagmus (6.1) Epilepsy in patients 3 to 12 years of age: viral infection, fever, nausea and/or vomiting, somnolence, and hostility (6.1) To report SUSPECTED ADVERSE REACTIONS, contact BioComp Pharma, Inc. at 1-866-762-2365 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. Postherpetic Neuralgia The most common adverse reactions associated with the use of gabapentin in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema. In the 2 controlled trials in postherpetic neuralgia, 16% of the 336 patients who received gabapentin and 9% of the 227 patients who received placebo discontinued treatment because of an adverse reaction. The adverse reactions that most frequently led to withdrawal in gabapentin-treated patients were dizziness, somnolence, and nausea. Table 3 lists adverse reactions that occurred in at least 1% of gabapentin-treated patients with postherpetic neuralgia participating in placebo-controlled trials and that were numerically more frequent in th...