The Australian army and Roche Products Australia face a class action after allegations that army personnel had serious side effects after being prescribed mefloquine hydrochloride (Lariam) as part of a research trial for a new anti-malarial drug.
Since 1998, the Army Malaria Institute, a research organisation of the Australian Army, has been working with the Royal Thai Army and the US Army to trial an experimental drug, tafenoquine. In 1999, the institute, in collaboration with SmithKline Beecham, started a trial reportedly of about 600 Australian troops serving as part of the United Nations peacekeeping forces in Bougainville and later in East Timor. Mefloquine was used as the comparator.
Simon Harrison, a lawyer with the Brisbane based legal firm Quinn and Scattini, plans to file legal complaints in the next few weeks on behalf of numerous service personnel, complaining about serious side effects from the drug. Mr Harrison says that army personnel were not adequately informed about the potential side effects. The legal action will allege that the plaintiffs had depression, kidney damage, paranoia, and suicidal thoughts after taking the drug.
The Australian drug regulator, the Therapeutic Goods Administration, requires Roche Australia to include a four page product information sheet with prescriptions of the drug. The current information sheet, prepared in 1998, warns consumers who experience “depression, restlessness, confusion, feeling anxious or nervous” to inform their doctor immediately. “Other side effects not listed above may also occur in some patients,” it states.