THE COMPANY which manufactures Roaccutane, the controversial drug used for the treatment of severe acne, has discontinued its manufacture and distribution in the United States.
However, Roche said yesterday it had no plans to stop supplying the drug in Ireland. It said the decision in the US, notified to the Food and Drug Administration (FDA) on Friday, was taken for business reasons and not for reasons of safety or efficacy.
In a statement it said its market share for the drug in the US had steadily declined to below 5 per cent since the drug came off patent, and generic alternatives became available. Therefore, it was no longer keeping it on the market.
But its statement went on to refer to the fact that the company has also been faced with high costs from personal injury lawsuits taken by people who used the drug in the US, though it stressed it continues to defend these vigorously.
In the US, juries have awarded at least $33 million in damages to users who blamed the drug for bowel disease. In November, for example, a jury in New Jersey found Roche officials didn’t properly warn doctors about the drug’s health risks and awarded three men a total of $12.9 million in damages.
The drug has also been linked to birth defects and depression.
But in its statement Roche said it was proud of the drug and “stands behind the safety of Accutane”, pointing out that it had been used in the treatment of severe acne by more than 13 million patients worldwide since it was introduced in 1982.
The drug was marketed as Accutane in the US and as Roaccutane here.
In May last year the Irish Supreme Court rejected a bid by Roche to stop a Dublin father bringing a case against it for alleged wrongful death following the death by suicide of his 20-year-old son in June 1997.
Liam Grant of Terenure, in Dublin, claims his son Liam’s death by suicide was a side effect of his use, for the treatment of acne, of the drug Roaccutane. Roche denies the claim. The case has yet to be heard.
A spokeswoman for Roche in Ireland said the drug was staying on the market in the Republic because no generic equivalents had been launched here. “If we got to the same situation as in the US with an erosion in the market share we would evaluate the situation again,” she said.
She added that no compensation had been paid out in Ireland on foot of claims in relation to the drug.
The Irish Medicines Board confirmed the drug was still authorised for sale in the Republic.
“Roaccutane [Isotretinoin] is currently authorised in Ireland and across the EU for the treatment of severe forms of acne [such as nodular or conglobate acne or acne at risk of permanent scarring] resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy,” it said.
According to the newswire Bloomberg, the drug has also been taken off the market in 11 other countries, including Denmark, France and Spain.