Bisi ABASS

 

The National Agency for Food and Drug Administration and Control (NAFDAC) has warned that Ruzurgi (Amifampridine) tablets are contaminated with yeast, mould and aerobic bacteria based on laboratory test results.

The agency’s Director-General, Prof. Moji Adeyeye therefore warned against the sale and use ofthe drug.

Adeyeye said the U.S. Food and Drug Administration has already recalled the drug.

The recalled Ruzurgi, the brand name for amifampridine, came in 100-count bottles of 10 mg tablets. The lots have control No. 18038, with expiration 03/2023 (distributed only in Canada, where the problem was found); control No. 18039, expiration 03/2023; and control No. 18079, expiration 05/2023.

RUZURGI is indicated for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in patients that are six to less than 17 years of age. LEMS is an autoimmune disease in which the immune system attacks the body’s tissues.

The attack occurs at the connection between nerve and muscle (the neuromuscular junction) and interferes with the ability of nerve cells to send signals to the brain.

In addition, the NAFDAC boss added that the use of the defective product in patients with underlying immunosuppressive conditions such as LEMS increases the concern for serious infections.

She encouraged health professionals and patients to report adverse events or quality problems experienced with the use of the medicine to the nearest NAFDAC office.

Meanwhile, she called for the handover of the remaining stock to the agency’s nearest office or via pharmacovigilance@nafdac.gov.ng
or the website — www.nafdac.gov.ng.

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