Hexachlorophane (Hansard, 18 February 1972)

§ Sir K. Joseph

Yes. The Committee on Safety of Medicines has reported to me in the following termsHexachlorophane is a long-established antibacterial agent which is a constituent of a wide range of medicinal products, disinfectants, toileteries and cosmetics. It is less liable to cause skin irritation and sensitisation than some other agents. Recent experimental studies in the United States indicate that in certain circumstances hexachlorophane can induce brain damage in animals. This damage is usually reversible if administration is stopped but these studies must be accepted as providing circumstantial evidence of potential toxicity in man. Experience of the human use of hexachlorophane extends for over 22 years but the Committee on Safety of Medicines is unaware of any evidence that preparations containing hexachlorophane are harmful to human adults or infants when used in accordance with the manufacturer's instructions. The higher strength hexachlorophane preparations on the market are promoted for medicinal purposes and have been used in hospitals in many countries as prophylaxis against staphylococcal colonisation and disease. In particular, in the hospital care of the newborn, regimes involving skin cleansing of the babies and their attendants with hexachlorophane have resulted in the reduction of the incidence of infection. It is now clear that detectable amounts of hexachlorophane can appear in the blood after application of such preparations containing hexachlorophane to the skin; it therefore seems prudent to emphasise that a potential hazard may exist from the use of these 184W preparations and extra care should be observed. The decision as to when the benefits of using hexachlorophane preparations outweigh any possible risk must be left to the judgment of the individual physician. Appropriate advice has already been made available to hospitals by the manufacturer of one of the preparations widely used in hospital practice.

RECOMMENDATIONS

The Committee accept the value of hexachlorophane as an antibacterial substance but in the light of the evidence now available they recommend:

(a) that all hospitals, local authorities, doctors, pharmacists, nurses and midwives should be informed of a possible hazard in administering and using preparations containing hexachlorophane when total body bathing or widespread application to the skin is contemplated. Particular caution should be observed in such use in infancy.
(b) that a cautionary notice should appear on the immediate wrapper or container of all soaps containing hexachlorophane for medicinal use to the effect that widespread washing with these soaps should not be undertaken except on medical advice.
(c) that the co-operation of the industry should be sought with a view to ensuring that products containing hexachlorophane for medicinal use on infants such as talcs, powders, creams, lotions and emulsions, should only be recommended for use on medical advice; sales of such products should only be made through registered pharmacists and these products should not be advertised to the general public."

I have accepted these recommendations. Steps will be taken to bring the views expressed by the Committee to the attention of those referred to in recommendation (a). Consultation with representatives of industry and of the Pharmaceutical Society have already begun on the other recommendations.

As far as non-medicinal preparations are concerned, short-term studies are now under way to investigate the absorption of hexachlorophane in man from toilet preparations and cosmetics under various conditions of use. Until the outcome of these studies is known, I am advised that it would be premature to suggest that any specific precautions in the use of these products are called for. I should emphasise that no evidence of hazard to health in man has been seen in the many years during which hexachlorophane has been used in such preparations.