More Problems after Fast Drug Approvals

A new study adds to the evidence that serious side effects of new drugs often show up later. It also shows that drugs approved through a fast-track process may be more likely to have problems. The study looked recent drug approvals in Canada and what was learned about the drugs after approval. Researchers focused on 434 drugs. They were approved between 1995 and 2010. Most drugs went through a 300-day standard approval process. About 1 out of 4 went through a 180-day process. The fast process is used if a condition has no good treatments, or if the new drug may offer a major advantage over current treatments. Of the drugs that went through the standard process, one-fifth became the subject of a serious safety warning or were withdrawn from the market. These problems occurred for about one-third of drugs that went through the fast approval process.