FDA is recalling anti-epileptic drugs | Tech Reddy

• Chiu Chi-chou and Lin Hui-ching / Staff Correspondents

The Food and Drug Administration (FDA) yesterday recalled 1.077 million Epilramate film-coated tablets after testing found that several batches of the drug contained insufficient amounts of its key ingredient.

Two batches of Epilramat 25 mg film-coated tablets (batch nos. 190441 and 210466) and two batches of Epilramat 100 mg film-coated tablets (batch nos. 210467 and 210471) should be withdrawn from the market, the release said.

FDA Drug Specialist Hsu Chih-yu (許芷瑀) said the drug’s main ingredient is topiramate, which is primarily used in the adjuvant treatment of partial-onset epilepsy in adults and children over the age of two, as well as Lennox-Gastau syndrome and epilepsy. primary generalized tonic-clonic epilepsy.

Photo courtesy of the Food and Drug Administration

The drug can be used to treat or prevent migraines in people with partial seizures.

“During drug stability testing, TWi Pharmaceuticals found that the amount of the main ingredient in two types of tablets was 94 percent lower than the FDA-approved 95 and 105 percent,” Hsu said. “The impurities in the two types of tablets were 0.33 percent and 0.54 percent, respectively, which also exceeded the FDA standard of 0.25 percent.”

“We have asked TWi Pharmaceuticals to recall both types of pills by December 2, as medical effects may be compromised due to errors,” he said.

Photo courtesy of the Food and Drug Administration

The National Health Insurance System covered 120,000 Epilramate 25mg tablets and 320,000 100mg tablets last year, its database shows.

TWi was also required to submit a report on the recall process and subsequent corrective actions, Hsu said.

Medical facilities and pharmacies across the country should follow the recall efforts, he said, adding that people who have received the drug should contact their doctors if they have concerns.

Separately, more than 80 percent of the nation’s medical facilities are expected to resume normal nuclear medical services this week after an emergency request to increase domestic supplies of technetium-99, the FDA said.

The global supply of technetium-99, a radioactive isotope commonly used in imaging, was disrupted last week due to an unexpected mechanical failure of the BR2 nuclear reactor in Belgium. Hospitals have canceled or postponed exams in nuclear medicine departments because of the suspected shortage of the substance.

Yang Bo-wen (楊博文), chief of the FDA’s drug division, said technetium-99 is the main substance used to image the thyroid and salivary glands, as well as the heterotopic lining of the stomach and tear ducts.

The government has authorized five suppliers to import the controlled substance. Three of the suppliers reported a supply shortage.

Young said domestic demand for technetium-99 is difficult to gauge, adding that the FDA has asked importers to increase their supply of the substance.