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Reprinted from:
reutershealth.com/archive/2002/05/17/eline/links/20020517elin026.html

Action group urges Britain to withdraw acne drug Roaccutane

(Reuters Health)

By Patricia Reaney

LONDON (Reuters) - An international action group urged British health officials Friday to ban a controversial acne drug that has been linked with patient suicides.

Liam Grant, whose son killed himself after taking the drug Roaccutane, told the Medicines Control Agency (MCA)--the body that licenses drugs in Britain--that it is dangerous and increases the risk of depression.

Fifteen people in Britain have committed suicide and 10 others have attempted to kill themselves while taking the drug, according to MCA statistics. Swiss pharmaceutical group Roche Holding AG makes the drug.

"We're saying to the MCA withdraw the drug, ban the drug until Roche completes further safety studies," Grant, chairman of the International Roaccutane Action Group, told Reuters.

"We feel the MCA have no alternative but to do that."

The action group, which has 2,000 members in Britain and Ireland and is affiliated to similar groups around the world, told the MCA that scientific studies would show exactly what effect the drug has on the central nervous system.

But Grant said Roche has refused to do them.

Roche claims its drug has been safely used by millions of people and said there is no scientific proof that it increases the risk of depression or suicide.

"There is no evidence that Roaccutane is actually responsible for these cases (of suicide)," Dr. Trisha Campbell, the UK head of medical affairs for Roche, told the BBC.

"There could be umpteen reasons why these cases have occurred."

No one at the MCA was immediately available to comment on the meeting.

Roaccutane, a vitamin-A based drug, has been licensed in Britain since 1983. It is prescribed for the treatment of severe acne and carries warnings on possible side effects.

In the United States, where the drug is sold under the name Accutane, the family of a Florida teen-ager who flew a plane into an office block have filed a $70 million wrongful death lawsuit against the drug manufacturers.

The US Food and Drug Administration has received reports of 37 patients using the drug who committed suicide, 24 while on the drug and 13 after they stopped taking it.

Grant said there are 41 published studies linking the use of Roaccutane with the emergence of depression and suicide. The action group also claims the drug is over-prescribed.

"We're saying it has to be banned until such time that they do the most basic studies that will prove one way or another (if it is safe)," he added.

Copyright © 2002 Reuters Limited. All rights reserved.

Reprinted from:
reutershealth.com/archive/2002/05/17/eline/links/20020517elin026.html

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Action group urges Britain to withdraw acne drug Roaccutane  May 18 2002

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