Over a quarter of biologicals show AEs that led to a warnings within a decade, says JAMA study

An article published in the late October issue of the Journal of the American Medical Association suggests that over a quarter of all biotechnology drugs demonstrated side effects that led to safety warnings within a decade. Between January 1995 and June 2008, a total of 174 biologicals were approved (136 in the USA and 105 in the European Union, of which 67 were approved in both regions). 82 safety-related regulatory actions were issued for 23.6% of them. The probability of an action, derived from Kaplan-Meier analyses, was 14%, 9%-19% three years after approval and 29% 10 years later. First-in-class biologicals had a higher risk for a first safety warning compared with products approved later in the same class.