Consumer reporting of adverse drug reactions

A ny new medication or therapy that has been approved for market authorization after extensive tests and trials is supposed to be efficient and, more importantly, safe. Yet, drug safety is not guaranteed: Many medications can still cause unexpected side effects that only come to light after approval. One of the worst examples is thalidomide, which caused severe birth defects and malformations in babies born to mothers who had taken the drug as a sedative against morning sickness and nausea in the late 1950s and 1960s. The thalidomide scandal was not only a wake-up call to improve drug testing and increase the requirements for safety, but it also made clear that a system for monitoring post-market drug safety was required. Many countries established reporting systems for adverse drug reactions to inform authorities about unexpected side effects. Today, spontaneous post-market reporting is the principle means for registering side effects and other problems with medical products on the market and it helps authorities to quickly react to any problems. Nonetheless, there is still much room for improvement given that adverse drug reactions are one of the leading causes of morbidity and mortality in health care.