Issued by: South African Medicines Control Council
PRESS RELEASE BY PROFESSOR PETER FOLB, CHAIRMAN OF THE SOUTH AFRICAN MEDICINES CONTROL COUNCIL.
Re: Unauthorised use of Virodene
1. The Medicines Control Council has received reliable reports of widespread administration to patients with HIV infection and AIDS of Virodene (dimethyiformamide, an industrial solvent and human poison). An investigation has been initiated by the MCC that has included inspection of the various facilities concerned and interview of a number of persons responsible.
2. Severe adverse toxic reactions to Virodene have developed in patients, and these have been reported to the MCC.
3. Any use of Virodene as a medicine is illegal and unethical. The Medicines Control Council has, accordingly, handed the matter to the police for urgent investigation and appropriate action.
4. Details regarding any pharmacists and doctors who may be involved in the administration of Virodene to patients will be given to the police and to the professional councils of the individuals concerned. Disciplinary action against them will follow.
5. The MCC has serious concerns, based on the best available scientific knowledge and advice, that Virodene is unsafe and potentially dangerous to humans when given as a medicine for HIV infection and AIDS. Virodene has not been shown to be of any benefit for this purpose.
6. Virodene is an impure industrial solvent and toxic substance, used in the plastics industry, and it is quite inappropriate for medicinal use in humans in the form and manner in which it is being distributed.
7. The persons presently responsible for the production, distribution and prescription of Virodene have been fully and repeatedly advised that its use for this purpose is unsafe, of no value, misleading to patients, unethical, and against the law.
8. If any patient were to be maimed, made seriously ill, or were to die as a result of the injurious and toxic adverse effects of Virodene, or because they had been misled by the health professionals responsible, all the persons concerned are likely to be held personally responsible and criminally negligent.
Further details available from Prof PI Folb at 021 47 1618; fax 021 448 6181.