New medicines for serious conditions: do the risks outweigh the benefits?
No medicine is 100 percent safe. Medicines regulators need to decide whether the advantages of taking the medicine outweigh the disadvantages, and ask if the side effects are acceptable. Analysis of the risks and benefits associated with new medicines is very complex — what risks and benefits are we talking about, and how should they be weighed? Where the condition is serious and/or rare, these decisions can be even harder...