Angioedema: There have been postmarketing reports of angioedema in patients during initial and chronic treatment with Pregabalin. 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 immediately in patients with these symptoms.
Exercise caution when prescribing Pregabalin 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.
Hypersensitivity: There have been postmarketing reports of hypersensitivity in patients shortly after initial of treatment with Pregabalin. Adverse reactions included skin redness, hives, rash, dyspnea, and wheezing. Discontinue Pregabalin immediately in patients with these symptoms.
Withdrawal of Antiepileptic Drugs (AEDs): As with all AEDs, withdraw Pregabalin gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. If pregabalin is discontinued, taper the drug 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 drugs for any indication. Monitor patients treated with AEDs for any indication of the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
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