When people suffer a side effect or injury while taking a pharmaceutical product, often the first question is “Did the drug cause my injury?” This is a difficult question to answer and not one that a google search is likely to easily answer.
Medical professionals and the FDA consider a variety of information in determining whether or not a drug caused an injury. They look at clinical trials, epidemiology, animal studies, and adverse event reports. When a person suffers side effects or injuries that occurred while taking a drug it can and should be reported to the FDA.
Reporting Drug Side Effects
Reporting an injury or side effect to the FDA is important to making sure only the safest and most effective drugs remain on the market. The FDA compiles all of these reports in a database called the “adverse event” database or FAERS. The adverse event database assists the FDA in deciding when to warn the public about side effects.
According to FDA estimates, only about ten percent of all adverse events are actually reported to the adverse event database. Therefore the true number of serious side effects is approximately ten times higher than the FDA numbers.
Individuals, along with their doctor’s assistance, are in the best position to decide whether the benefit of a drug outweighs the risks it carries. However, individuals are unable to make informed decisions about the drugs they take if they are not provided with all the risks.
Clinical trials are studies where one group of participants takes a drug and another group takes a placebo or a different drug. Oftentimes clinical trials are not able to answer the question of whether a drug caused an injury because the participants are limited and may not ultimately have the same medical history of the individuals ultimately prescribed the drug. For example, a clinical trial may not allow people who drink alcohol to participate, but obviously people who drink alcohol will be taking the drug once the drug is available to the public.
Additionally, if a side effect or injury is rare it would be unusual for the side effect to show up in a clinical trial with a small group of individuals. For example, the FDA recently changed the warning label for DPP IV inhibitors, such as Januvia, Nesina, Onglyza, and Tradjenta because of the risk of a serious skin disease called “bullous pemphigoid.” There are only 2.4 occurrences of bullous pemphigoid per 100,000 person year. In a small clinical trial, it is highly unlikely that this serious side effect would appear.
Epidemiology studies are expensive, time consuming, and difficult to conduct. Epidemiology is the study and analysis of patterns, causes and effects of health and disease conditions in defined populations. Epidemiology produces evidence-based studies that are able to identify risk factors but they are not conducted for every drug and every potential side effect of injury.
For all of these reasons it is important that people report any side effects or injuries that happen to them while they are taking pharmaceuticals. Doctors can, and should, report side effects or injuries to the FDA or pharmaceutical companies. However, often doctors don’t report because they are too busy or don’t recognize that a drug may have caused the injury.
For all of these reasons, it is imperative that consumers understand that the need to report drug injuries or side effects is great. Reports are a critical way the FDA can detect injuries or side effects early and prevent it from unnecessarily happening to others
More information about how to report Adverse Events can be found here.