Drug approval was cautionary withheld in many countries since 2002 because of increase risk of severe liver toxicity. The FDA never approved it for use in the USA. The EMA (European Drug Agency) introduced limitations for use by narrowing indication profile, shortening duration of treatment, age restriction for younger than 12 year, and avoiding it in pregnancy and breastfeeding. Latest update failed to find relevant data on breastfeeding. Its high molecular weight and plasma protein binding make excretion into breast milk unlikely. However, anti-inflammatory drugs that are known to be safer for both the mother and the infant should be preferred.