Yes. There's a package insert with each drug. It contains a description of the drug, specifies the risks involved, and provides certain indications. It is clear that under the statute and regulations, the manufacturer should be obliged to indicate to the user where to report any adverse effect. This would allow users to provide greater feedback. Therefore, those who believed, rightly or wrongly, that they experienced adverse effects could draw the attention of public authorities to this problem.
On April 29th, 2008. See this statement in context.