Call Us: 1.800.873.5297

By

FDA Requires Black Box Warning for GSK’s Anti-Seizure Drug Potiga® Due to Risks of Retinal Abnormalities

Pill BottleOn October 31, 2013, the FDA issued a Drug Safety Communication informing the public that the FDA has “approved changes to the drug label of the anti-seizure drug Potiga® (ezogabine), underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent.” The FDA also required a new Black Box Warning, the most serious type of warning, due to the risk of abnormalities of the retina (a part of the eye necessary for vision). The FDA’s Safety Announcement also advises health care professionals that Potiga® should 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.”

On April 26, 2013, the FDA previously issued a Drug Safety Communication regarding Potiga® due to risks of eye abnormalities and blue skin discoloration. At that time, the FDA warned the public “that the anti-seizure medication Potiga® (ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina” and the FDA did not know “if these changes are reversible.” The FDA reported that pigment changes in the retina have the potential to cause serious eye disease with loss of vision, while the blue skin discoloration typically occurred after four years of treatment with Potiga® and appeared predominantly on the lips or nail beds of the fingers or toes (although more widespread skin discoloration of the face and legs had been reported). The FDA provides photos of the blue skin discoloration experienced by patients taking Potiga®.

The updated label now contains warnings regarding the risk for skin discoloration associated with Potiga®, as discussed in the April 2013 Drug Safety Communication. According to the FDA, the “updated Potiga® drug label states that if a patient develops skin discoloration, an alternate medication should be considered. The FDA also announced that it is working on modifying the current Risk Evaluation and Mitigation Strategy (REMS) for Potiga® in order to evaluate and address the risk of potential vision loss, abnormalities of the retina, and skin discoloration.

Potiga® is manufactured by GlaxoSmithKline (GSK) and was approved by the FDA in June 2011 to treat partial-onset seizures in adult patients 18 years or older. Potiga® is an anticonvulsant medication that opens potassium channels in brain cells, which stabilizes the brain’s electrical system and thus reduces seizures. According to the FDA, approximately 10,900 prescriptions of Potiga® were dispensed between April 2012 and February 2013.

 

Legal Disclaimer: The choice of a lawyer is an important decision and should not be based solely on advertisements.

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.