FOLLOWING the death of two ladies from Benue State after being treated with the banned Gentamycin 280mg injection, the National Agency for Food and Drugs Administration and Control (NAFDAC) has ordered all hospitals, pharmacies and other outlets still stocking the product to immediately surrender them to the nearest NAFDAC office for destruction.
According to him, anyone found using the banned product would be prosecuted for homicide. Gentamicin is an antibiotic used to treat many types of bacterial infections. NAFDAC on October 7, 2010 banned Gentamycin 280mg injection from circulation by informing healthcare providers and the general public on deregistration and subsequent withdrawal.
The agency said the regulatory action was consequent upon recent safety data associating the use of high dose, single unit Gentamycin injection with ototoxicity (causing deafness), nephrotoxicity (kidney damage) and increase incidence of endotoxin (a toxin kept within the bacterial cell and to be released only after destruction of the bacterial cell wall) reactions.
Endotoxin reactions include anaphylactic shock (difficulty in breathing and shock ultimately leading to death), haemorrhage (bleeding), fribinolysis (a process that prevents blood clots from growing and becoming problematic), hypotension (low blood pressure), inflammation (localised reaction that produces redness, warmth, swelling, and pain as a result of infection, irritation, or injury), vascular coagulation (a serious disorder in which the proteins that control blood clotting become abnormally active) among other unpleasant side effects.
Investigation by NAFDAC team, which was made public at a press conference yesterday in Lagos by the Director-General, Dr. Paul Orhii, revealed that Miss Florence Bagidi, a final year student of Benue State University, died following intravenous administration of Gentamycin 280mg injection by Mr. Reuben Obasi, a secondary school certificate holder and patent medicine store operator.
The NAFDAC boss said Obasi, who is currently being detained at the homicide section at the Police Headquarters in Makurdi, has been interrogated and he admitted administering the drug on the late Bagidi. Orhii said the agency was collaborating with the homicide section of the police to conduct thorough laboratory analysis on the drug.
The Batch Number of the Gentamycin 280mg injection is 110102; Manufacturing Date, 01/2011; and Expiring Date, 01/2014.
The second death caused by the drug, according to Orhii, was that of Miss Florence Saawuan, a National Certificate of Education (NCE) holder who was hospitalised for adverse drug reaction diagnosed to be Stevens-Johnson Syndrome (SJS) and died after four days of treatment at Victory Hospital, Gboko, Benue State. NAFDAC investigation revealed that Gentamycin 280mg was one of the drugs used in the management of the patient.
Orhii said the NAFDAC team discovered and retrieved the banned injection, unregistered Doloneurobion tablets and Cimetidine injection from the hospital. He said the medical doctor supervising the hospital has provided information on the supplier of the drugs and tendered a receipt belonging to Chimex Medical Limited, D-Line 411 Head Market, Onitsha.
According to him, the information has led to the arrest of Mr. Chukwudi Nworie, who admitted supplying the offending products to the hospital. Orhii said Chukwudi informed the team that he sourced the products from one Chukwudi and Chinedu at Onitsha Head Bridge Drug Market.
The NAFDAC boss gave details of the implicated product as Engaent Gentamycin sulphate 280mg injection with batch number 101204, manufacturing number, 12/2010, expiring number 12/2013 and manufactured by Zhejiang Jinling Tiafeng Pharmaceutical Factory, No. 11, Chezhan Road, Huzhou City, Zhejiang, China.
Orhii lamented that despite the ban of Gentamycin 280mg injection in October 2010, some hospitals and medical practitioners continue to stock and use the product and other banned or withdrawn medicines and they also do not report adverse drug reactions of approved medicines for proper review and appropriate documentation in the adverse drug reaction form, yellow form.