I'm not sure why d they mention rare adverse reactions? Any idea, of what purpose does this serve? Like here in the case of Cetirizine
It is mentioned only for the information that although this side effect is rare or very rare but may occur it should be in your knowledge.
Any drug-related AES, which also defined By GCP E2A as Adverse Drug Reactions should be collected and documented. Even if they are not Serious (as per GCP definition) they could be or are indicative for adversity related to the medicatio and thus could influence risk-benefit ratio.
When a side effect is listed as “common,” what does that mean? What are the odds of a “rare” side effect happening to me? It was news to me that these terms are actually very specific. The World Health Organization (WHO) defines categories as:
- Very common means 1 in 10 — 1 out of every 10 people (or more) taking that medicine will experience that side effect.
- Common means more than 1 in 100 — between one in 10 and one in 100 people are affected
- Uncommon means more than 1 in 1,000 — between one in 100 and one in 1,000 people are affected
- Rare means more than 1 in 10,000 — between one in 1,000 and one in 10,000 people are affected
- Very Rare means more than 1 in 10,000+ — fewer than one in 10,000 people are affected
I found these definitions to be comforting. After all, a rare effect that happens to 1 in 1,000 to 10,000 seems safe. Then I pulled out my calculator. As an example, Crestor is one of the most prescribed drugs in America, through June 2015. It “rarely” causes liver damage (among other things). 21 million prescriptions for Crestor were written from July 2014-June 2015. Doing the math reveals that it’s possible that between 2,100 and 21,000 people in the US suffered new onsets of liver damage from taking Crestor each year.
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