Acitretin is the generic name of Roche’s psoriasis drug that seems to have got under the skin of the drug regulators. It is also another example to be added to the growing list of drugs that gets an easier passage through the European regulatory framework than the US one.
Acitretin has been available in the UK since the late 1980s, marketed as Neotigason. It is known to cause birth defects, and so it is a drug that must not be prescribed to pregnant women or to those breastfeeding.
Roche had successfully convinced the English regulators that the drug was perfectly safe for women who wanted to become pregnant two years after taking the drug. But then the company came up against the slightly harder wall of the US Food and Drug Administration.
The drug had been approved in 1996, but had never been marketed when the FDA was asked to take a closer look. Acitretin was promoted as the safer option to etretinate (Tegison), but reports were indicating that acitretin was being metabolised into etretinate in some patients and so had an even higher potential to cause birth defects.
The FDA finally agreed to change the warning, and increase the period between finishing the drug and conceiving to at least three years. Roche pushed for the European two years’ warning, while several members of the evaluating panel wanted to extend the warning for an indefinite period.
As a result, American doctors now have a boxed, bold type warning about the drug in their drug reference guide, whereas their British equivalents still have to rely on the small print.
Aside from possible birth defects, other adverse reactions include eye problems, headaches, stomach ache, tinnitus and sinusitis.