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Potiga (Withdrawn)
Generic Name: Ezogabine
Drug Category: Antiepileptic
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 4 years.
| Approved Uses |
|
Indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments and for whom the benefits outweigh the risk of retinal abnormalities and potential decline in visual acuity. –POTIGA can cause retinal abnormalities with funduscopic features similar to those seen in retinal pigment dystrophies, which are known to result in damage to the photoreceptors and vision loss. Macular abnormalities characterized as vitelliform lesions have also been observed. –Approximately one third of the patients who had eye examinations performed after approximately 4 years of treatment were found to have retinal pigmentary abnormalities. –All patients taking POTIGA should have baseline and periodic (every 6 months) systematic visual monitoring by an ophthalmic professional. Testing should include visual acuity, dilated fundus photography, and optical coherence tomography. Additional testing may include fluorescein angiograms, perimetry, and electroretinograms. –POTIGA should only be used in patients who have responded inadequately to several alternative treatments and for whom the benefits outweigh the potential risk of vision loss. Patients who fail to show substantial clinical benefit after adequate titration should be discontinued from POTIGA. –POTIGA can cause skin discoloration. The skin discoloration is generally described as blue, but has also been described as grey-blue or brown. It is predominantly on or around the lips or in the nail beds of the fingers or toes, but more widespread involvement of the face and legs has also been reported. Discoloration of the palate, sclera, and conjunctiva has also been reported. Information on the consequences, reversibility, time to onset, and pathophysiology of the skin abnormalities remains incomplete. –POTIGA caused urinary retention in clinical trials. Urinary retention was generally reported within the first 6 months of treatment, but was also observed later. Closer monitoring is recommended for patients who have other risk factors for urinary retention (e.g., benign prostatic hyperplasia [BPH]), patients who are unable to communicate clinical symptoms (e.g., cognitively impaired patients), or patients who use concomitant medications that may affect voiding (e.g., anticholinergics). In these patients, a comprehensive evaluation of urologic symptoms prior to and during treatment with POTIGA may be appropriate. –A study of cardiac conduction showed that POTIGA produced a mean 7.7-msec QT prolongation in healthy volunteers titrated to 400 mg 3 times daily. The QT prolonging effect occurred within 3 hours. The QT interval should be monitored when POTIGA is prescribed with medicines known to increase QT interval and in patients with known prolonged QT interval, congestive heart failure, ventricular hypertrophy, hypokalemia, or hypomagnesemia. –Confusional state, psychotic symptoms, and hallucinations were reported more frequently as adverse reactions in patients treated with POTIGA than in those treated with placebo in placebo-controlled epilepsy trials. –Antiepileptic drugs (AEDs), including POTIGA, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. –Alcohol increased systemic exposure to POTIGA. Patients should be advised of possible worsening of ezogabine’s general dose-related adverse reactions if they take POTIGA with alcohol. –Pregnancy: Based on animal data, may cause fetal harm. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Dosage greater than 400 mg 3 times daily (1,200 mg per day). GoToSource • Monotherapy. GoToSource • Neuropathic pain, bipolar disorder, migraine headaches and restless legs syndrome. GoToSource |
| Adverse Events |
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Urinary retention, including urinary hesitation. GoToSource Hallucinations, psychosis, anxiety and QT prolongation. GoToSource Dizziness, somnolence, fatigue, confusion, dysarthria, urinary tract infection, ataxia and blurred vision. GoToSource Blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. GoToSource |
| Litigation |
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Lawsuits filed for retinal abnormalities, vision loss and skin discoloration. GoToSource |
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