The drug was deemed substandard by persons living with HIV.
The National Agency for Food and Drug Administration and Control, NAFDAC, has suspended the use of Tryonex, a brand of Antiretroviral, ARVs, medicines in the country. This was due to concerns expressed by Treatment Action Movement, TAM, a coalition of HIV activists in Nigeria and other similar organisations.
Distributed under the Federal Government’s National HIV/AIDS program, Tryonex is a local brand of ARV medicine produced byTryonex Nigeria Limited, a Lagos-based company, with funding from the Millennium Development Goals, MDGs, funds through the Federal Ministry of Health. It contains Zidovudine, Lamivudine and Nevirapine. The latter of the three is no longer accepted for use by the World Health Organisation but is still in circulation in Nigerian hospitals.
In July 2013, the Director General of the National Agency for the Control of AIDS, NACA, John Idoko, confirmed in an interview with PREMIUM TIMES that Nevirapine was still in circulation in Nigerian hospitals but would be gradually phased out.
A document dated December 20, 2013, signed by the Director, Pharmacovigilance unit of NAFDAC, Adeline Osakwe, on behalf of the agency’s Director General and addressed to all Antiretroviral Treatment (ART) Centres, stated, “NAFDAC in collaboration with the Federal Ministry of Health, FMOH, and NASCP commenced immediate investigations into the quality and associated clinical issues which is ongoing. Pending the final outcome of this investigation, ART centres are advised to immediately switch their patients to alternative brands of ARVs. Furthermore, NAFDAC directs the immediate suspension of all Tryonex brands of ARV medicines in all ART centres in the country until a definitive status of safety and quality of the Tyonex brand of ARVs are determined. This is with immediate effect to enable us safeguard Public Health.”
The eventual suspension was due to TAM members’ going to hospitals to physically cart away all consignments of the drug to prevent its further use by People Living With HIV/AIDS, PLWH.
NAFDAC says story of HIV drug-related death is untrue
Following a recent claim by TAM that a woman in Asaba, Delta State, Gloria Nwagwu, died after using Tryonex, Mrs. Osakwe, in an interview with PREMIUM TIMES on Friday, refuted the story, calling it untrue.
“People die every day for various reasons. It is not true that someone died as a result of taking the drug. But investigations are ongoing about the drug as well as in relation to the death claims,” said Mrs. Osakwe.
However, PLWH have deemed the drug “substandard” because it dissolves easily in the mouth before swallowing and is said to be poorly packaged.
The National Coordinator of TAM, Obatunde Oladapo, said, “The package presentation is substandard, the labelling is amateurish, resembling the work of professional counterfeits and street drugs peddlers. Some of the labels were actually upside down with conflicting and incorrect instructions for use.”
Mr. Oladapo alleged that one of the patients of AIDS Healthcare Foundation, AHF-Nigeria, had observed that one of the packages she collected in a treatment centre contained 54 tablets and a broken half instead of 60. This was supposed to be a 27-day supply of drugs with a half tablet that is of no use for a pack that is expected to last for 30 days. The drug literature, he noted, was also stuffed inside the same plastic pack as the ARVs, giving little assurance of hygienic handling of the tablets during packaging.
Reactions to suspension
In an interview with PREMIUM TIMES on Friday, Sunny Ochigbo of the Network of PLWH said that he fully supported the suspension of the drug.
“It’s a good move in the right direction. Some clients have reported having side effects from the use of this brand,” he said.
According to medical experts, some of the side effects include severe vomiting with blood in the puke, terrible weight lose, and deteriorating health.
A 43-year-old mother of four, living with HIV, Ariyike Onaolapo, 43, expressed her disappointment in NAFDAC’s handling of the drug’s distribution.
“I thought they are supposed to test these drugs. If they did, how come we are experiencing side effects? NAFDAC is a regulatory body that doesn’t only oversees the registration of pharmaceutical products but is supposed to test them before approving for use by the public. This goes to show a serious regulatory failure on the parts of NAFDAC. If not, during the test, the low standard of the drug should have been spotted or is there more to it which we’re not being told,” she said.
Mrs. Osakwe, however, stated that this was not a regulation failure as all drugs approved by NAFDAC were tested and thoroughly investigated before being approved for public consumption.
“Since there are allegations about the drug, that is why we are re-investigating it. We do test all drugs before sending them out. It’s alleged that this is a poor quality medicine and someone died so we have to investigate. We have done the pharmacovigilance quality aspect of the drug,” she insisted.
She added that a substantial part of the ongoing investigation had been done but said she was not in a capacity to tell when the reports would be made public. She explained that on completion of its investigation, NAFDAC would submit all its reports to the Federal Ministry of Health, which was conducting its own investigations. She said the reports could be made public in a week.
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