A 38-year-old man, seeking the withdrawal of a controversial acne drug from the market in Ireland, is taking his campaign to the EU.
Jason O’Sullivan is raising questions about potential side effects of Acuttane, which is the subject of thousands of law cases in several countries, with more than 7,000 pending in the court of New Jersey alone.
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, who came off the drug after only nine days, said his face and head swelled. He suffered headaches and muscle and joint pain and continued to be affected by chronic fatigue and other side effects.
He is being supported by Fine Gael MEP Seán Kelly, who hopes his case will be considered by the EU Petitions Committee.
Mr O’Sullivan, from Muckross, Killarney, claims more than 6,000 Irish people are suffering side-effects from the drug.
“I want to make people aware of the possible side effects of this drug, which was used originally in chemotherapy,” he said.
Switzerland-based Roche Holding AG, the world’s biggest maker of cancer drugs, took Acuttane off the US market in 2009 after juries awarded more than $33m (€26.6m) in damages to users who blamed the drug for bowel disease. The drug also has been pulled off the market in 11 other countries, including France, Denmark, Austria, Germany, Portugal, and Spain.
A Roche spokesperson, however, said Acuttane’s safety was not a factor in the decision to take it off the US market.
Roche is standing behind the safety of the drug and the rigorous risk-management programme the company developed over decades of co-operation with the federal drugs authorities, she stated.
The company also said it took the decision after a “reevaluation” of its product lines showed the drug faced serious challenges from generic competitors.
Roche also emphasised it was continuing to vigorously defend personal injury law cases.
A data sheet issued by Roche and agreed with by the Irish Medicines Board includes anaemia, headache, and dryness as common problems associated with the drug.
It lists infections, depression, anxiety, and mood alteration among “rare problems”, while suicide and psychotic disorders are among the “very rare problems”, it says.
Last June, a New Jersey jury awarded a total of $18m to two former users of Accutane who blamed the medicine for their bowel disease.
However, the jury rejected similar claims against Roche by two other people, finding the company acted appropriately in providing information to the medical, scientific and regulatory communities.
Last week, a judge in a Florida case ruled in favour of Roche, also finding that the company provided adequate warnings of the side effects, including inflammatory bowel disease.
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