The United States Food and Drug Administration has validated the Tyonex brand of anti-retroviral drugs as safe and devoid of any substance capable of causing injury or death to people living with HIV/AIDS.

 

The FDA case/sample report issued from its Forensic Chemistry Centre in Cincinnati, Ohio, dated March 3, 2014, and obtained by our correspondent, states, “Per an e-mail communication from Mr. Michael Deats, World Health Organisation on December 5, 2013, the suspect tablets were examined for the presence of active pharmaceutical ingredients.

 

“One tablet was examined using Fourier transform infrared (FT-IR) spectroscopic imaging. A five-tablet composite was examined using liquid chromatography with mass spectrometric detection (LC/MS) and gas chromatography with mass spectrometric detection (GC/MS).

 

“A seven-tablet composite was examined using high performance liquid chromatography with ultraviolet detection (HPLC-UV).

 

“Using FT-IR spectroscopic imaging, a portion of one tablet was consistent with the presence of zidovudine, nevirapine and lamivudine, based on spectral comparisons with standards.

 

“Using LC/MS and GC/MS, the five-tablet composite was consistent with the presence of lamivudine, zidovudine and nevirapine based on retention time and mass spectral comparisons to corresponding reference standards.

 

“No other drugs or poisons were identified in the composite under the experimental conditions used.”

 

The release was signed by Dr. Adam Lanzarotta, and attested to by four others, with a copy of the result sent to the WHO.

 

Sometime in 2013, some HIV/AIDS advocacy groups and the Treatment Action Movement, a human rights group, had complained that the Tyonex brand of antiretrovirals was responsible for the death of some persons living with the virus.

 

In response, the Managing Director of Tyonex Nigeria Ltd., Mr. Tyohemba Agba, said, “The definitive clearance from the US FDA, which is easily the world’s most respected food and drug regulatory authority, is a major boost to the Federal Government’s fight against drug adulteration.

 

“It also vindicates Tyonex, the manufacturer and marketer of the ARVs, which has always maintained that its products are safe.”

 

Agba noted further that the report validated the report of some Nigerian institutions that examined the drugs and proclaimed it as safe for human use.