The days of Arava (leflunomide) may be numbered. The drug, which treats rheumatoid arthritis, has been linked to 12 deaths in the USA alone.
The Food and Drug Administration, the US drug regulator, has received 130 reports of severe liver toxicity from people taking the drug since it was licensed for use in 1998. Of these, 56 were treated in hospital, and 12 died. Two of those who died were in their 20s.
Similar reactions have been reported in Europe, and the European Agency for the Evaluation of Medicinal Products issued an urgent warning last year to patients and doctors about the drug's toxicity.
Public Citizen, a consumer watchdog group, has petitioned the FDA to remove the drug from the marketplace. In a comparison between leflunomide and methotrexate, another antiarthritic drug, leflunomide was linked to six times more cases of fatal liver toxicity and 13 times more reports of hypertension than methotrexate, even though five times more prescriptions had been written for methotrexate.
The drug was also linked to 12 cases of Stevens-Johnson syndrome, a serious systemic skin condition, an adverse reaction not seen with methotrexate.
The drug stays in the body for a long time so that, even if a patient stops taking it, the adverse reactions may continue for months afterwards.
Side-effects include diarrhoea, nausea, vomiting and anorexia, headache, dizziness, hair loss, eczema, dry skin, jaundice, anxiety, ruptured tendons and anaemia.
The link with possibly fatal liver toxicity was suspected at the time of licensing, but it has taken a citizen's group action to force the regulator's hand. 'No more patients should be subjected to these risks,' says Dr Sidney Wolfe of Public Citizen.
Let's hope that the regulators on both sides of the Atlantic agree - and quickly.