Oct. 29, 2021
National Food and Drugs Administration and Control (NAFDAC) has cautioned against the sale, distribution and use of recalled lots of Ruzurgi (Amifampridine) 10mg tablets.
The agency’s Director-General, Prof. Moji Adeyeye on Friday gave the warning in a statement following the recall of the drug by the U.S. Food and Drug Administration (U.S.-FDA).
Adeyeye explained that NAFDAC was informed by the U.S.-FDA that the drug was found to be contaminated with yeast, mold and aerobic bacteria based on laboratory test results.
She added that the use of the defective product in patients with underlying immunosuppressive conditions such as LEMS increases the concern for serious infections.
She called for handover of the remaining stock to the agency’s nearest office or via pharmacovigilance@nafdac.gov.ng
or the website — www.nafdac.gov.ng.
She, therefore, appealed to health professionals and patients to report adverse events or quality problems experienced with the use of the medicine to the nearest NAFDAC office.
LEMS is an autoimmune disease in which the immune system attacks the body’s own 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.
