- After years of requiring comprehensive warnings in package inserts, the FDA is endorsing warnings on drug labels that highlight the most serious risks and use less technical language.
- Package inserts now require that drug makers list every single possible side effect, drug interaction and adverse event, however 40% of consumers said they never read the warnings section, according to FDA research.
- FDA research also shows that 55% of consumers who do read the package insert find the language and the overall warnings difficult to understand.
While the rule has long been to make sure that consumers are exposed to information about every single potential risk associated with a particular drug, this approach has not been effective, simply because it actually discourages consumers from reading it. In addition, there is the problem of overly technical language that may be hard to understand.
The new guidance suggests more accessible language, such as using the word "drowsiness" instead of "somnolence" or "fainting" instead of "syncope." The hope is that easier-to-understand warnings will encourage consumers to actually read the package insert—and really understand all the risks.