I just heard an ad on the radio for a prescription pill (don’t recall the name) to treat men with advanced prostate cancer. One of the warnings was that it may cause harm to an unborn child. How could that work?
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They’ve added that warning because they have no data on fetal toxicity, and are covering their legal butts.
There’s no data on fetal toxicity for obvious reasons – that’s pretty low research priority for a prostate medication.
But it’s not inconceivable that someone would take their husband’s medication by mistake, so they’re checking off the “told ya so” box in case of frivolous lawsuit.
The laws that say they have to put the warning up there, or at least what they interpret as such, does not bother to differentiate between drugs that are advertised to female, men, kids, dogs, grandmothers, etc. It would just be too much to have to go through each possible symptom and check who can get it or not. So this warning is shown on any drug which have not been proven to not cause birth defects. It is even possible that a doctor prescribe this drug to females as it often have other uses then what they are advertising for. For example if this is a pain killer which does work well with prostate cancer that may also work well in other cases, for example pains associated with pregnancy. They just chose not to advertise this in the same advertisement.
When clinical studies are done, you have to document _everything_ that happens and, unless you can **prove** otherwise, list those things as _potential_ side effects of the medication.
In this case, it is likely that someone in the clinical trial had a child born with some defect or malady, so it was listed as a potential side effect – true or not.
I don’t know about this medicine specifically. However, there are medicines that shrink the prostate that cause birth defects.
Females who may be pregnant shouldn’t touch Finasteride or Dutasteride because it can be absorbed by the skin and cause birth defects. You should also be using protection with sex, since it can get into the semen.
It’s possible this medicine does something similar, so the warning is in effect.
The laws that say they have to put the warning up there, or at least what they interpret as such, does not bother to differentiate between drugs that are advertised to female, men, kids, dogs, grandmothers, etc. It would just be too much to have to go through each possible symptom and check who can get it or not. So this warning is shown on any drug which have not been proven to not cause birth defects. It is even possible that a doctor prescribe this drug to females as it often have other uses then what they are advertising for. For example if this is a pain killer which does work well with prostate cancer that may also work well in other cases, for example pains associated with pregnancy. They just chose not to advertise this in the same advertisement.
I know a couple whose child had birth defects because the dad was on some acne medication when they conceived. It can affect the sperm.
When clinical studies are done, you have to document _everything_ that happens and, unless you can **prove** otherwise, list those things as _potential_ side effects of the medication.
In this case, it is likely that someone in the clinical trial had a child born with some defect or malady, so it was listed as a potential side effect – true or not.
They’ve added that warning because they have no data on fetal toxicity, and are covering their legal butts.
There’s no data on fetal toxicity for obvious reasons – that’s pretty low research priority for a prostate medication.
But it’s not inconceivable that someone would take their husband’s medication by mistake, so they’re checking off the “told ya so” box in case of frivolous lawsuit.
Thalidomide can cause birth defects when taken by men for cancer treatment because it can be transmitted in semen.
The warning can also be there for off-label use. Lots of medications are used that way.
Thalidomide was originally intended to be a sedative (which it apparently didn’t do) but was found to be an effective anti-nausea drug and doctors gave it to pregnant women with severe morning sickness. It had never been tested on pregnant women. That caused a rash of severe physical deformities in babies born to those mothers and it was taken off the market in the early 60s. FWIW, the FDA never approved the drug as it never passed trials. It was approved in other countries though.
Came back into use as a treatment for leprosy, and the FDA approved it for that use, and then it was found to be effective for treating cancer.
Quite a journey for that one.
I don’t know about this medicine specifically. However, there are medicines that shrink the prostate that cause birth defects.
Females who may be pregnant shouldn’t touch Finasteride or Dutasteride because it can be absorbed by the skin and cause birth defects. You should also be using protection with sex, since it can get into the semen.
It’s possible this medicine does something similar, so the warning is in effect.
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