Face Cream Link To Deformity
Sydney Morning Herald
Friday June 25, 1993
A number of face creams marketed as anti-acne treatments - but being used as beauty treatments to "erase" signs of aging - will no longer be sold over the counter in Australia following reports that they may cause birth defects.
The National Health and Medical Research Council (NHMRC) announced yesterday that all States and territories had agreed to reschedule the products - which contain tretinoin or retinoic acid, a breakdown derivative of vitamin A - to S4, so they could be obtained only under prescription.
The chairman of the NHMRC, Dr Tony Adams, said there had been four reported cases, two from Australia, of children born with congental defects to mothers who had used retinoic acid during the early stages of pregnancy.
The deformities have appeared on the babies' ears and fingers - this is typical of vitamin A-related deformities.
There are four products being sold in Australia containing retinoic acid: Retin-A (Janssen-Cilag), Airol (Roche), Retrive (Dermatech) and Stiva-A(Stifel).
Dr Adams said the creams, lotions and gels had only been given approval for use as acne treatments and should not be used for any other purpose.
Retrive is approved for use to treat people with chronic dry skin problems
However, in recent years, stories about the potential of the creams to erase the signs of aging, including sun spots, wrinkles and uneven pigmentation, have been carried by the media, particularly women's magazines.
Retinoic acid is a keratolytic. It works by taking off the external layer of skin, through blistering and scaling and when the skin heals, it appears smoother and paler.
Dr Adams said given the large number of women who used the product, there was not a correlating high number of birth defects linked to the cream. However, while the concerns existed, people at risk should be advised.
Lifting the creams to prescription-only status ensured people using them were under medical supervision.
"Women of child-bearing age should be aware of the risks," he said.
According to Dr Adams, the risk of deformities being caused existed only during the first few weeks of pregnancy - often a time when women are not even aware they are pregnant.
"If women are using these creams they should be using contraception, and if they are using these creams and pregnant, or trying to have a child, they should speak to their doctor."
The medical director of Janssen-Cilag, Dr Michael Wyer, said Retin-A had first been approved in 1970 and the cream version became available in Australia in 1980.
Dr Wyer said sales figures were not available.
"The data that we have does not indicate there is any problem. Absorption of the cream (into the bloodstream) is minimal."
He said the company had never marketed Retin-A as anything but an acne treatment.
Asked if the company had ever issued a statement responding to reports that their product could be used to "erase" signs of aging, and warning against it, Dr Wyer replied: "Not that I can recall."
The managing director of Dermatech, which markets Retrive, Mr John Parsonage, said the company was surprised that a prescription would now be required for the product but that it did not concern him.
Between June 1992 and May 1993, 4,700 tubes had been sold through dermatologists in Australia.
The Herald was unable to contact a representative from Roche and Stifel.
© 1993 Sydney Morning Herald