Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- damage to the photoreceptors and vision loss… Macular abnormalities characterized as vitelliform lesions have also been observed.
- their reversibility are unknown… Reversibility of retinal pigmentary abnormalities and partial resolution of vitelliform lesions has been reported after iscontinuation of ezogabine in some patients.
- dilated fundus photography,… and optical coherence tomography…
WARNINGS AND PRECAUTIONS
Retinal Abnormalities and Potential Vision Loss
- photoreceptors and vision loss… In addition, macular abnormalities characterized as vitelliform lesions have been observed; such lesions may also be seen in macular degenerative and dystrophic disorders. These lesions have been identified most consistently with optical coherence tomography imaging. reversibility after drug discontinuation are unknown...
- Reversibility of retinal pigmentary abnormalities and partial resolution of vitelliform lesions has been reported after discontinuation of ezogabine in some patients.
- should include visual acuity testing, dilated fundus photography,… and optical coherence tomography. Additional testing may include fluorescein angiograms, perimetry, and electroretinograms.
- In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of POTIGA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Acquired vitelliform lesions.
- WARNING: RETINAL ABNORMALITIES AND POTENTIAL VISION LOSS (new section)
5 WARNINGS AND PRECAUTIONS
5.1 Retinal Abnormalities and Potential Vision Loss
- POTIGA can cause abnormalities of the retina. The abnormalities seen in patients treated with POTIGA have funduscopic features similar to those seen in retinal pigment dystrophies that are known to result in damage to photoreceptors and vision loss.
- The retinal abnormalities observed with POTIGA have been reported in patients who were originally enrolled in clinical trials with POTIGA and who have generally taken the drug for a long period of time in 2 ongoing extension studies. Approximately one third of the patients who had eye examinations performed after approximately 4 years of ......
- Funduscopic abnormalities have most commonly been described as perivascular pigmentation (bone spicule pattern) in the retinal periphery and/or as areas of focal......
- Patients should have baseline ophthalmologic testing by an ophthalmic professional and follow-up testing every 6 months. The best method of detection of these abnormalities and the..... If retinal pigmentary abnormalities or vision changes are detected
- POTIGA should be discontinued unless no other suitable treatment options are available and the benefits of treatment outweigh the potential risk of vision loss.
5.3 Skin Discoloration
- 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.
- Approximately 10% of patients in long-term clinical trials developed .....The possibility of more extensive systemic involvement has not been excluded. If a patient develops skin discoloration, serious consideration should be given to changing to an alternate medication.