If the mechanism of action of paracetamol is unknown, why is it considered a safe drug to use for humans?

Question

If the mechanism of action of paracetamol is unknown, why is it considered a safe drug to use for humans?

In: Biology

Answer 1

There is no requirement that we understand how a drug works in order to get approval. The testing that’s required is just for safety and efficacy. There’s no testing required that demonstrates how it works molecularly. There are a number of drugs that probably don’t work via their listed mechanisms at approval: eg, enbrel (actives th17 cells) and Avandia (cdk inhibitor).