There is no particular criterion. However, when we see that this drug is not acting in a way that it is supposed to act.... We can get the information. Right now we are getting other professionals--doctors and pharmacists--to get that information. There are side effects attached to each and every drug. If there's something outside of the side effects that have been written there or that are well known, then we do report.
On February 28th, 2008. See this statement in context.