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Potiga FDA Alerts

The FDA Alerts below may be specifically about Potiga or relate to a group or class of drugs which include Potiga.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Potiga

Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration

Jun 16, 2015 | Audience: Neurology, Eye Care, Dermatology

ISSUE: Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the FDA has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling. To further explore any potential long-term consequences of these pigment changes, FDA has required the Potiga manufacturer, GlaxoSmithKline, to conduct a long-term observational study.

FDA review of additional safety reports does not indicate that the pigment changes in the retina observed in some patients affect vision. Skin discoloration associated with the use of Potiga appears to be a cosmetic effect and does not appear to be associated with more serious adverse effects. Therefore, a modification of the Risk Evaluation and Mitigation Strategy (REMS) is not needed at this time to ensure that the benefits of Potiga outweigh the risks of retinal and skin pigment changes. FDA expects that the required long-term observational study will provide further information on whether pigment changes in the retina caused by Potiga can lead to vision loss or other long-term side effects. In addition, the study should provide more information on the relationship between pigment changes in the retina and skin discoloration.

BACKGROUND: Potiga is approved for use in combination with other anti-seizure drugs to treat partial-onset seizures in adult patients who have had an inadequate response to several alternative therapies and for whom the benefits of treatment outweigh the risks.

RECOMMENDATION: Health care professionals should continue to follow the recommendations provided in the Boxed Warning, FDA’s most serious type of warning, and the Warnings and Precautions and Indications and Usage sections of the labeling.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[06/16/2015 - Drug Safety Communication - FDA]

Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration

Nov 1, 2013 | Audience: Health Professional, Neurology, Patient

UPDATED 11/01/2013:  FDA approved changes to the drug label, underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent. The revised label includes a new boxed warning, because of the risk of abnormalities to the retina. FDA advises that Potiga use be limited to patients who have not responded adequately to several alternative therapies to decrease the frequency of seizures, or epilepsy, and for whom the benefits of treatment outweigh the risks.

AUDIENCE: Health Professional, Neurology, Patient

ISSUE: FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. FDA is working with the manufacturer to gather and evaluate all available information to better understand these events. FDA will update the public when more information is available.

BACKGROUND: Potiga is approved as adjunctive (added on to other anti-seizure medications) treatment of partial-onset seizures in adult patients 18 years and older. Pigment changes in the retina have the potential to cause serious eye disease with loss of vision. It is not yet known whether the retinal pigment changes caused by Potiga lead to visual impairment, although several patients have been reported to have impaired visual acuity. In some cases, retinal abnormalities have been observed in the absence of skin discoloration. The skin discoloration in the reported cases appeared as blue pigmentation, 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. Scleral and conjunctival discoloration, on the white of the eye and inside eyelids, has been observed as well. The skin discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner in some patients.

RECOMMENDATION: In light of this new safety information all patients taking Potiga should have a baseline eye exam and periodic eye exams that should include visual acuity testing and dilated fundus photography, and may include fluorescein angiograms (FA), ocular coherence tomography (OCT), perimetry, and electroretinograms (ERG). Potiga should be discontinued if ophthalmic changes are observed unless no other treatment options are available. If a patient develops skin discoloration, serious consideration should be given to changing to an alternate medication. Patients who are taking Potiga and develop any changes in their vision or any discoloration of their skin, including of their lips and nail beds, should contact their health care professional right away.

Patients should not stop taking Potiga without talking to their health care professional.  Stopping such treatment suddenly can cause serious and life-threatening medical problems such as recurrence of seizures. 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety

Information and Adverse Event Reporting Program:

 

[10/31/2013 - Drug Safety Communication - FDA
[04/26/2013 - FDA Safety Communication - FDA]

Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration

Apr 26, 2013 | Audience: Health Professional, Neurology, Patient

ISSUE: FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. FDA is working with the manufacturer to gather and evaluate all available information to better understand these events. FDA will update the public when more information is available.

BACKGROUND: Potiga is approved as adjunctive (added on to other anti-seizure medications) treatment of partial-onset seizures in adult patients 18 years and older. The skin discoloration in the reported cases appeared as blue pigmentation, 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. Scleral and conjunctival discoloration, on the white of the eye and inside eyelids, has been observed as well. The skin discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner in some patients. In some cases, retinal abnormalities have been observed in the absence of skin discoloration.

RECOMMENDATION: All patients taking Potiga should have a baseline eye exam and periodic eye exams that should include visual acuity testing and dilated fundus photography, and may include fluorescein angiograms (FA), ocular coherence tomography (OCT), perimetry, and electroretinograms (ERG). Patients who are taking Potiga and develop any changes in your vision or any discoloration of your skin, including of your lips and nail beds should contact their health care professional right away. Patients should not stop taking Potiga without talking to their health care professional.  Stopping such treatment suddenly can cause serious and life-threatening medical problems such as recurrence of seizures.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety

Information and Adverse Event Reporting Program:

[04/26/2013 - FDA Safety Communication - FDA]

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