Man vows to continue bid to get acne drug withdrawn

Despite a number of setbacks, a 39-year-old man is to continue his campaign for the withdrawal of a controversial acne drug from the market in Ireland.

Jason O’Sullivan, who raised questions about potential side effects of Accutane, had his case for the removal of the drug, rejected by the Oireachtas Public Petitions Committee and the EU Petitions Committee.

He has been unable to work as a heavy machinery driver since he took the prescribed drug for a skin complaint in 1998.

Mr O’Sullivan, from Muckross, Killarney, who came off the drug after only nine days, said his face and head swelled, he suffered headaches, muscle and joint pain and continued to be affected by chronic fatigue and other side effects.

Switzerland-based Roche Holding AG, the world’s biggest maker of cancer drugs, took Accutane off the US market, in 2009, after juries awarded more than $33m in damages to users who blamed the drug for bowel disease.

Use of the drug and its side effects are the subject of thousands of law cases in several countries, with more than 7,000 pending in the state courts of New Jersey, USA.

Mr O’Sullivan believes thousands of Irish people are suffering side effects from the drug which, he said, was intended for chemotherapy rather than skin conditions.

“People need to be aware of what they are being prescribed. I want to make people aware of the possible side effects of this drug which was used originally in chemotherapy,” he said.

He has been supported by Fine Gael MEP Sean Kelly, who helped bring his case to the EU Petitions Committee and, more recently, by Independent TD Michael Healy-Rae, who raised the issue in the Dáil.

Mr Healy-Rae said Mr O’Sullivan’s life had been “turned upside down” and he was adversely affected by the drug every minute of the day.

But former minister of state for health, Róisín Shortall said the drug was authorised here only for severe forms of acne which were resistant to other standard therapies.

“The benefits of the treatment are considered to outweigh the risks when the product is used in accordance with approved product information,” she said.

Roche Holding has defended the safety of the drug and the risk-management programme it developed with the federal drugs authorities.

Roche also said it took the decision to take the drug off the US market after a “re-evaluation” of its product lines showed it faced serious challenges from generic competitors.

A data sheet issued by Roche and agreed with the Irish Medicines Board includes anaemia, headache and dryness as common problems associated with the drug. It said infections, depression, anxiety and mood alteration were “rare problems” while suicide and psychotic disorders are among “very rare problems”.