Glatiramer acetate is safe in pregnancy. #ClinicSpeak #MSBlog #NewsSpeak
Pregnancy is an important issue in the DMT space. As you know the majority of pwMS are women and as the average age of onset is 30 years of age pregnancy is a big issue. The good news is that the EMA have allowed the pregnancy guidance of glatiramer acetate to be updated; in short GA is safe in pregnancy. The label change was based on the outcome of over 8,000 pregnancies over a period of more than 20 years.
The label now reads: “Studies in animals have not shown reproductive toxicity (see section 5.3). Current data on pregnant women indicate no malformative or feto/neonatal toxicity of Copaxone. To date, no relevant epidemiological data are available. As a precautionary measure, it is preferable to avoid the use of Copaxone during pregnancy unless the benefit to the mother outweighs the risk to the foetus.”
Please note that despite overwhelming safety data Teva and EMA prefer to sit on the fence by asking the person with MS and their HCP to make a judgement call.
I must admit that we at Barts-MS have been advising our patients that glatiramer acetate is safe in pregnancy. The label change is useful and helps protect us and makes our prescribing safer. The issue of off-label prescribing has been described many times on this blog and remains an issue. In essence doctors are allowed to prescribe off-label, but if anything goes wrong and they are challenged legally they will have to defend their decision. Their defence is often based on what their peer-group is doing and if their peers will support them. Off-label prescribing should at least have a sound scientific rationale and some evidence to support it. This is why it is becoming increasingly difficult to innovate in medicine; the suits (lawyers and administrators) are making us wear straight-jackets. Gone are the days when you had an idea and asked your patient if you could try drug x, if it worked you would try in a few more patients and see what happened. If the results looked good then you would proceed to doing a trial. The latter process is how so many drugs were repurposed.
Labels: EMA, glatiramer acetate, pregnancy, press release