Pregabalin (Lyrica): findings of safety study on risks during pregnancy

[helvella]

Particularly in the light of diogenes post the other day about Sodium valproate, this MHRA warning needs to be read and spread.

The emphasis on the risk being only slight seems unsatisfactory. If you are the mother, or child, affected, what does it matter that you drew the short straw?

Pregabalin (Lyrica): findings of safety study on risks during pregnancy

A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy unless clearly necessary.

gov.uk/drug-safety-update/p...

Please feel free to copy this and pass it on however you wish.

[Mollyfan]

With the best will in the world I am not sure what you would prefer them to do? It clearly states to avoid in pregnancy unless clearly necessary and to use contraception. Would you prefer that a really useful drug was withdrawn from use for everyone? I do think that patients and doctors should discuss the pros cons and risks and make an informed choice but surely the patient bears some responsibility too….?

The danger is that there will be a blanket ban on drugs in pregnancy despite the individual situation and we will then be moaning because the doctor didn’t listen and do what we considered best.

Smoking, recreational drugs and alcohol have well recognised risks in pregnancy but a large number of women choose to use them.

[helvella in reply to Mollyfan]

I think that the warning should be a black box warning.

And even a fairly up to date SmPC only says:

4.6 Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females

As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential.

Pregnancy

There are no adequate data from the use of pregabalin in pregnant women.

Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

Pregabalin Mylan should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).

medicines.org.uk/emc/produc...

[Mollyfan in reply to helvella]

I don’t mean to be difficult, but isn’t “Pregabalin Mylan should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).” Clear enough?

[helvella in reply to Mollyfan]

No. It isn't.

a) It should say MUST - not SHOULD.

b) It shouldn't require careful reading to reach the warning. That is, it should be in a black box - the usual way of highlighting important issues.

The epilepsy section of the BNF is more helpful and complete:

bnf.nice.org.uk/treatment-s...

But few patients would get to read that.

[BadHare]

This is a very dangerous drug. I have met several people at pain management that find it beneficial as well as others that have had potentially terminal consequences. It was prescribed for me by a consultant at a time I was too ill & drugged on other pharmaceuticals to read the enclosed information leaflet. Retrospectively, the written warnings were insufficient.

[SarahJane1471 in reply to BadHare]

I think that’s quite a harsh statement. Quite a lot of medication CAN be dangerous if incorrectly used. Pregabalin pretty much saved my life when I was prescribed it for PTSD. I still take it and it keeps me sane. It was originally used for epilepsy then pain relief and is now the recommended treatment for PTSD sufferers. Of course at 57 I won’t be getting pregnant. It is a drug that can be abused as can many drugs. Helvella was pointing out the risks to pregnancy and that the warning should be clearer.

[helvella in reply to SarahJane1471]

Yes - I was pointing that out.

But only because the MHRA has decided to issue a warning email. In this instance, I feel I posted as a messenger.

May I ask, despite the point you make about your age, were you fully aware of the issues of its use during pregnancy?

[SarahJane1471 in reply to helvella]

No. But by the time I was prescribed it by a psychiatrist 9 yrs ago I was past the age of getting pregnant 🤷‍♀️. But I agree with your point. It has only recently become a drug on the controlled list ( couple of years ago). I believe it’s not prescribed so easily now. In fact at the time it was only psychiatrists that could prescribe off label for PTSD.

[BadHare in reply to SarahJane1471]

I had a very harsh reaction after two tablets. A friend even more so.