29th October, 2021
By Aderogba George
The National Agency for Food and Drug Administration and Control (NAFDAC) has warned against the sale and use of Ruzurgi (Amifampridine) tablets.
The agency’s Director-General, Prof. Moji Adeyeye said the U.S. Food and Drug Administration has already recalled the drug.
Adeyeye said NAFDAC was informed by the FDA that the drug was found to be contaminated with yeast, mould and aerobic bacteria based on laboratory test results.
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 [email protected]
or the website — www.nafdac.gov.ng.
NAN