How do pharma companies know all of the possible side effects that could happen from taking their meds? What is done to minimize the number of side effects a medicine can cause? How are they passed by the FDA with all of those side effects?

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How do pharma companies know all of the possible side effects that could happen from taking their meds? What is done to minimize the number of side effects a medicine can cause? How are they passed by the FDA with all of those side effects?

In: Chemistry

3 Answers

Anonymous 0 Comments

Like what the poster said above, drug development is a very long process (Phases 1-3, then Phase 4 which is post-marketing surveillance). If the drug belongs to a therapeutic class where other drugs are already around and have a known side effect profile, then there is a big chance that the side effects of the new drug will be similar, albeit of a different severity (e.g., less drowsiness for the newer antihistamines). When they do in vitro and animal testing, they find out some of the side effects then. Then they test the drug in a few healthy people then in a lot of people (thousands) both healthy and with varying diseases. When the sample size is that big, you are bound to find many side effects, some related to the drug, some unrelated to the drug.

For your second question, you can change the dose or and dosing schedule of the drug, you can administer other drugs that minimize the side effects, you can have a list of other drugs to avoid taking simultaneously with the drug, or a list of disease conditions, age limits, genetic factors, etc that should avoid taking the drug.

For your third question, if the benefit outweighs the harm, then the drug is approved. For example, if you were to die of cancer and the chemotherapy drugs have really bad side effects, then it would benefit you to take the drug that saves your life and accept the risk of side effects.

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