Pregalin Special Precautions

Angioedema: There have been postmarketing reports of angioedema in patients during initial and long-term treatment with pregabalin. Specific symptoms included swelling of face, mouth (gums, lips, and tongue), and neck (larynx and throat). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in patients with these symptoms.
Discontinuation: Withdraw pregabalin gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. If pregabalin is discontinued, this should be done gradually over a minimum of 1 week.
Suicidal behavior and ideation: Antiepileptic drugs (AEDs), including pregabalin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients treated with any AED for any indication for the emergence of worsening of depression, suicidal thoughts or behavior, and any unusual changes in mood or behavior.
Peripheral edema: Pregabalin treatment may cause peripheral edema.
CNS effects: Pregabalin may cause dizziness and somnolence.
Weight gain: Pregabalin treatment may cause weight gain. Pregabalin-associated weight gain was related to dose and duration of exposure but did not appear to be associated with baseline body mass index, gender, or age. Weight gain was not limited to patients with edema.
Ophthalmological effects: In controlled studies, a higher proportion of patients treated with pregabalin reported blurred vision (7%) than patients treated with placebo (2%), which resolved in a majority of cases with continued dosing.
Congestive heart failure: Because there is limited data on congestive heart failure patients with New York Heart Association Class III or IV cardiac status, use pregabalin with caution in these patients.
Creatine kinase elevations, decreased platelet count, PR interval prolongation: Pregabalin treatment was associated with creatine kinase elevations, a decrease in platelet count, and mild PR interval prolongation.
Hypersensitivity reactions: There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with pregabalin. Adverse reactions included blisters, dyspnea, hives, rash, skin redness, and wheezing. Discontinue pregabalin immediately in patients with these symptoms.
Hazardous tasks: Pregabalin may cause dizziness and somnolence. Pregabalin-related dizziness and somnolence may impair abilities to perform tasks such as driving or operating machinery.
Use in Children: Safety and efficacy not established in children younger than 18 years of age.