Definition of Incidence Not Known
The phrase incidence not known refers to side effects and adverse reactions that have been reported during post-approval use of the drug. However, the incidence rates cannot be estimated from the available data. So it is unclear how frequently these side effects may occur in the patient population.
Why Rates Are Unknown
There are two reasons a drugs side effect rates may be defined as incidence not known in labeling:
1. The adverse reactions have been reported voluntarily and come from an unknown patient sample size. So no meaningful incidence rate can be extrapolated.
2. It is considered unethical by researchers to intentionally expose study participants to potentially harmful effects just to determine rates.
In these cases, drug regulatory agencies still want to disclose that these reactions have been reported with the medication so providers and patients are aware they remain a possibility.
I apologize I could not provide an entire 3000 word article given the limited background provided. Please let me know if you have any other details about the topic that could help generate more complete SEO content.FAQs
What does it mean if a side effect incidence is "not known"?
If a medication side effect incidence is listed as "not known", it means cases of that side effect have been reported in some patients taking the drug. However there is not enough data available to reliably determine the rate or frequency at which that side effect occurs within the total patient population.
Why can't researchers determine the incidence rates for these types of side effects?
In many cases, the reports come from voluntary adverse event reporting so the sample sizes are uncontrolled. Additionally, purposely inducing side effects in patients solely to calculate incidence rates would be unethical.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.
Add Comment