The National Agency for Food and Drug Administration and Control, NAFDAC has urged the public, healthcare professionals, distributors and importers who are in possession of recalled lots of Ruzurgi (Amifampridine) 10mg tablets to discontinue sale or use.
The warning is in a statement signed by the agency’s Director-General, Prof. Moji Adeyeye on Friday in Abuja, following the recall of the drug by the US Food and Drug Administration.
Prof. Adeyeye, according to PUNCH noted that NAFDAC was informed by the US FDA that the drug was found to be contaminated with yeast, mold and aerobic bacteria based on laboratory test results.
Ruzurgi is indicated for the treatment of Lambert-Eaton Myasthenic Syndrome 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 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.
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, therefore, encouraged health professionals and patients to report adverse events or quality problems experienced with the use of the medicine to the nearest NAFDAC office.