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Epilim Warning

Filed under: General — Downunder @ 9:27 am Thu 14th December 2023

Safety Alert 7 December 2023

Sodium valproate (Epilim) use in people who can father children:

important new safety information
Update to original communication

The Epilim data sheet and consumer medicines information leaflet have been recently updated with additional information about sodium valproate (Epilim) use in people who can father children.

Educational resources are also being updated.

The additional information includes the following.

Use of sodium valproate in people who can father children within the 3 months prior to conception may increase the risk of neurodevelopmental disorders in the child.

The potential risks to children fathered more than 3 months (the time taken for new sperm to be formed) after stopping sodium valproate are unknown.

If stopping sodium valproate, continue effective contraception for 3 months.

Do not donate sperm while taking sodium valproate and for 3 months afterwards.

Correction to the retrospective observational study results following reanalysis of one data set.

3 Comments »

  1. I looked up the drug, this was from the first site.

    “ If taken during pregnancy, sodium valproate can cause problems for a baby’s development, including birth defects and long term learning difficulties. For this reason, sodium valproate is not recommended if there’s a chance that you could become pregnant.”

    So for women the drug is bad, they have pregnancy prevention.
    To now say it’s bad for men, how is the drug even legal.
    The illness must be severe, to prescribe something so dangerous.

    Comment by DJ Ward — Sat 16th December 2023 @ 9:11 am

  2. There is thousands of medicines, all must have risks.
    The drug companies do studies, but they can’t test everything.
    But as we know, it seems even harmful medicine is OK.
    Every medication, has side effects for someone.
    So risk is not legislated away, side effects are acceptable.

    The medicine we have, looks more like the wild west.
    People selling ointments and concoctions, that didn’t work.
    New medicines are legalised, faster than we can assess them.
    Medicine we see as good, with side effects that were never tested.

    Birth defects sounds very bad to me, I bet that wasn’t in the approval.
    If you think about it, there will be thousands of bad medicines.
    What we see as good, one day we will see as bad.
    The medicine of today, is likely not the medication of tomorrow.

    Comment by DJ Ward — Sun 17th December 2023 @ 8:06 am

  3. Male fertility is an important subject, that has big consequences.
    We can find medicine, that does affect male fertility.
    Or something with a similar effect, like stopping sex drive.
    The ability to get an erection, a real problem for many.
    It’s not only about making bad sperm, many things are happening.

    But if it is true that medicine, can change male fertility.
    Why don’t men have a medicine, we should have contraceptives.
    Clearly we don’t, and is almost never mentioned.
    Thousands of medications, but nothing to stop male fertility.
    I guess there’s many things, sold as improving fertility.

    If men could control fertility, could society have a birth rate of two.
    Hence why male fertility, is only about improving fertility.
    If both genders could control fertility, the species would die.

    It’s an interesting question, why does the medication affect sperm.

    Comment by DJ Ward — Mon 18th December 2023 @ 7:26 pm

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