The Advertiser

Edition 1 Statemon 13 Jan 2003, Page 008

The `miracle' acne drug that critics claim has a darker side

By ALISON REHN in Canberra

A ``MIRACLE'' cure anti-acne drug has been blamed for a wave of teenage suicides.

The drug, known as Roaccutane in Australia, has been prescribed to millions of people around the world suffering severe acne in the past 20 years.
Patients who don't respond to conventional treatments have described Roaccutane as a ``miracle'' cure.

Experts and former patients of the drug in Australia and overseas claim the drug causes depression, aggressive and violent behaviour and, in some cases, suicide.
Disbelief and anger have surrounded the lack of warnings on Australia's labelling of the drug.Roaccutane, which contains the active ingredient isotretinoin, belongs to a group of medicines called retinoids, which are similar to Vitamin A.

The retinoids reduce the amount of oily substance made by glands in the skin.In the US, where the drug is known as Accutane, patients are given a document equivalent to 24 printed A4 pages, warning of the drug's side-effects.

The warning includes alerts that Accutane could cause depression, psychosis and suicide as well as a range of other debilitating side-effects.Australian patients are issued with the equivalent of only four pages, which have only recently been updated to include the suggestion that patients experiencing suicidal thoughts see their doctor.President-elect of the Australasian College of Dermatologists Alan Cooper said there was no proof Roaccutane caused depression and suicide.

``When you look at two very common problems, depression and acne, then, statistically, you're going to get a lot of people who get both,'' Professor Cooper, who is also head of dermatology at Royal North Shore Hospital, said.``Given that it's such an effective drug, given that it has helped so many people, as long as it's used properly then it would be an absolute tragedy if it were not available to these people in the future.''Donald Marks, a diplomat of the American Board of Internal Medicine who is an active practising physician, disagreed.

A former employee of the drug's manufacturer Roche Pharmaceuticals, Dr Marks said Roche and the US Government's Food and Drug Administration were aware Roaccutane caused depression and suicide.``It's well established that Accutane can cause depression and is associated with suicide,'' Dr Marks said.``First of all, Roche says it does, and the FDA says it does and the data very clearly shows it is capable of affecting the central nervous system,'' he said.Dr Marks said Australian warnings on the drug should be increased.``It's the Government's responsibility to make sure the drug company provides adequate warnings,'' he said.But Roche's Australian subsidiary has issued a statement stating ``the body of scientific evidence has not established a link between Roaccutane and depression and suicide''.The Therapeutic Good Administration, responsible for approving labels accompanying drugs in Australia, said it would continue to ``monitor the situation''.

THE FACTS* ABOUT 5 per cent of the Australian population will develop severe cystic acne.

* IT is administered to patients who do not respond to conventional acne treatments, including antibiotics.
* IT belongs to a group of medicines called retinoids, which are similar to Vitamin A, and has a specific action on the acne cysts.
* THE retinoids work by reducing the amount of the oily substance (ie sebum) made by glands in the skin, reducing bacteria and inflammation, and opening pores.
* THE medication can be prescribed only by a dermatologist and treatment must be supervised.* IT is taken orally with a treatment course lasting four to eight months
.* ROACCUTANE can cause serious side-effects, including dryness of lips, mouth, nose, eyes and skin; nose bleeds; tenderness or stiffness in bones, joints or muscles; peeling palms of the hands and soles of the feet; tiredness; headache, nausea and vomiting; eye problems; increased susceptibility to sunburn; hair loss; changes in hearing; stomach pain.
* IT is also known to cause serious birth defects, including mental retardation and physical malformation. Women must be taking contraceptives while taking the drug.
* IT is available under the Pharmaceutical Benefits Scheme. Each pack of Roaccutane, which contains 60 tablets, costs between $22.40 and $25.60.