Seizure Medication Potiga Discontinued

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
Posted on

Recently GlaxoSmithKline has decided to stop the manufacturing of their anti-seizure medication Potiga (ezogabine).

Medications are discontinued and taken off the market for a variety of reasons. Sometimes there are issues with safety, but sometimes a manufacturer will decide to discontinue a drug just because it’s no longer profitable. For example, this sometimes happens with brand name drugs that have a generic alternative—fewer and fewer people fill the more expensive brand over time.

Can a discontinued drug become available again?

Keep in mind that a discontinuation is different from a shortage. Shortages can be due to manufacturing issues, quality problems, delays anywhere along the manufacturing or shipping process—or by discontinuations. How does that work? Imagine there are two companies making a generic medication. One discontinues their generic version, and the other company now has to deal with a greater demand for a smaller supply. Shortages can be resolved, while discontinuations are permanent; a new application must be made to the FDA if a company wants to start making a discontinued drug.

What’s the process for discontinuing a medication?

It’s required that manufacturers alert the FDA if they intend to permanently discontinue a medication at least 6 months in advance, or as soon as possible.

What was Potiga used for?

Potiga was 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.

Why was Potiga discontinued?

GlaxoSmithKline has decided to discontinue Potiga due to very limited use and declining numbers of patients new patients starting the drug.

When was Potiga initially approved by the FDA?

Potiga was approved by the FDA in 2011.

When will Potiga no longer be available?

Potiga is no longer be available as of June 30, 2017.

Other than limited use, were there any issues with Potiga while it was on the market?

Yes. On April 26, 2013, just two years after the approval of Potiga, the FDA issued a drug safety communication stating that Potiga was causing skin discoloration and eye problems.

The FDA investigated these issues and on October 31, 2013, they approved label changes to include the most serious type of warning, a black box warning, alerting patients and prescribers that Potiga could cause potential vision loss and skin discoloration, which may be permanent.

On June 5, 2015, the FDA announced that it would require GlaxoSmithKline to conduct a long-term study to further explore any potential long-term consequences.

Is Potiga available in any other countries?

It was, but isn’t any longer. Until June 2017, Potiga was on the market in Europe under the name Trobalt, but it’s also been discontinued there.

Drugs featured in this story

Filed under