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.
Related Coverage
Learn how to identify products containing traces of nickel to avoid, recognize nickel-free certification logos to seek out, and discover options for making DIY non-irritating makeup....
Podiatrists routinely provide toenail trimming services using sterile tools to treat thickened, infected, or ingrown nails. Learn why you should see a podiatrist....
Looking for safe alternatives to hormone therapy? Discover 7 evidence-based natural menopause treatments like phytoestrogens, exercise, acupuncture, and more....
Drinking fresh fruit and vegetable juices can help reduce LDL and raise HDL cholesterol. Discover 12 tasty juicing recipes with apples, carrots, citrus and more....
Most dentists recommend flossing at night to remove food particles and plaque before it solidifies overnight, but flossing in the morning offers perks too....
Can hand sanitizer protect against respiratory syncytial virus (RSV)? Learn how proper hand hygiene habits including alcohol sanitizer use helps prevent RSV....
Liquid diets can spur quick weight loss and aid surgery recovery, but require balance. Get tips for safely creating tasty, nutritious liquid meals and shakes....
Applying heat with a hot water bottle can relax muscles, reduce stiffness, ease spasms and alleviate back pain. Learn proper usage, bottle types, safety tips....
Learn about limbal girdle of vogt, the pigmented band encircling the cornea. Discover its anatomy, functions, clinical significance, diagnosis, treatment options and prognosis....
Losing weight is hard, so celebrate your progress! Read about fun reward ideas for milestones like new clothes, spa days, trips and more that motivate you....