Can someone help me to understand why that information is printed

If you are pregnant or breastfeeding, or think you may be pregnant, or If you are planning to become pregnant, ask your doctor before taking this medicine or pharmacist for advice.

in package inserts of some medicines? What could a small doctor know more about that medicine, what the manufacturer could not know about their own product?

For me it is a useless information which takes space and time of each consumer to read. Why is it there?

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    For you it may be wasted space and time, but what if you were a woman who might be pregnant? Are you saying that doctors would never prescribe such a medication to such a patient, therefore the warning should be removed? Mistakes are made in medical prescribing; maybe the doctor forgot to ask. The manufacturer is required by law to warn of possible problems caused by the medication. If they know of a problem and do not report it or warn of it, they are subject to lawsuits. Commented Dec 18, 2023 at 17:45
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    The manufacturer is legally required to print it because they haven't tested the medicine to ensure it's safe in pregnant or breastfeeding women, so the regulatory agencies (like FDA in the US) say they have to print this to sell their drug over the counter. Doctors can read the scientific literature and guidelines from their professional societies and help their patients weigh the risks and benefits for a given medication, which vary from person to person, they're not working on their own. Unlike the manufacturer, doctors don't usually make money on OTC medicine, so they're a bit less biased.
    – Bryan Krause
    Commented Dec 18, 2023 at 17:47
  • @BryanKrause - D'oh! I wasn't thinking about that. It's like "not recommended for children under 12." I do buy OTC meds, but don't remember them coming with package inserts (to which I pay no attention anyway, so maybe that's why I have no memory of it.) Prescription meds, though, if boxed do have inserts. To which I pay no attention... Commented Dec 18, 2023 at 22:32
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    @anongoodnurse I was writing my comment same time as you and I wasn't thinking of prescription inserts! Together we have it covered. :)
    – Bryan Krause
    Commented Dec 19, 2023 at 0:21

1 Answer 1


The simplest answer is that the information won't fit on the insert. There are tradeoffs and decisions to be made. Some medications are just "don't take if you're pregnant" or "this is fine when you're pregnant" while others are not. It depends how far along you are, what conditions you have, what will happen if you don't take the medication, whether you plan to take one or two doses and no more, or several times a day for months, and so on. They can't print a whole flowchart of how to decide.

Another answer is that the manufacturers literally do not know, because they didn't study their drug in pregnancy. They don't want to take responsibility for advising you with nothing to base it on, so they hand off to the doctor to give you advice.

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