Monday, 6 February 2017

#ClinicSpeak & #NewsSpeak: glatiramer acetate and pregnancy

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. 




CoI: multiple

6 comments:

  1. Prof. G did Teva pay you for the free advertising? In addition, as a KOL you should not be recommending off-label prescribing; you and your colleagues are being irresponsible.

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    1. Re: "Prof. G did Teva pay you for the free advertising?"

      No not a penny. We have debated advertising before with the community and the message was clear that reader's want to keep this site advertising free.

      We post product specific information when it is relevant to pwMS. This includes press releases. You can search for other product specific press releases using the tag NewsSpeak. You may not think this post is relevant to people with MS, but it is. In addition, this information is as relevant to branded Copaxone as it is the emerging GA generics.

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    2. Re; "As a KOL you should not be recommending off-label prescribing; you and your colleagues are being irresponsible."

      You must be a newby to the blog. We have been actively promoting off-label prescribing for years. Off-label prescribing is allowed. We have a Barts-MS Essential Off-label DMT list to help HCPs manage MS in resource-poor settings.

      In addition, to this we have numerous posts and debates on the politics of off-label prescribing. Contrary to what you think off-label prescribing is alive and kicking.

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    3. I don't know what a KOL is either... First up on Dr Google Kingdom of Loathing...maybe this is where the questioner comes from :-)

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    4. I think I prefer Kingdom of Loathing ;-)

      Delete

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