Chances Midodrine Will Be Pulled?

[shan1212]

I've just now seen the survey circulating to tell the FDA to keep Midodrine on the market. It's my miracle drug so of course I immediately panicked. But then I did a little back-reading and saw that they originally threatened to pull the drug because the patent holder and original manufacturer, Shire, was refusing to go back and do more stringent trials. Shire wasn't motivated to do them because they had long since stopped making the drug, leaving it to generic companies to make. But anyway, then Shire agreed and spent millions of dollars and several years doing the studies, and now the studies are being reviewed. So what are the chances that the FDA would ask Shire to jump through those hoops only to turn around and pull it. There haven't been any deaths or anything like that, right?

Just wondering if my assessment that the FDA is unlikely to pull it, and that threatening to pull it back in 2010 was because Shire wasn't willing to do further trials, which have now been done, is correct. Fingers crossed! I can't count the number of times that Midodrine has saved me from a symptom-spiral.

[SarahA33]

It was a pretty close call back in 2010 if I remember correctly. The frustrating part is that it wouldn't have been taken off of the market for safety or effectiveness concerns. Like you said, it's about red tape with clinical trials basically. I get nervous every time I pick up my scripts and it's on back order!

I also worry about this issue happening with Ivabradine (corlanor) since it was fast tracked by the FDA in May. I hope we don't run into this problem with this medication in the future. I know Midodrine was fast tracked also.

A big concern if midodrine goes off the market is the lack of similar drugs (Not like Beta Blocker's where you can try 5 different type's!) The only other medication that I'm aware of approved for orthostatic hypotension is Northera. I don't see that mentioned all that much on the forum. I wonder if that is fast acting like midodrine and provides similar benefits. I take midodrine as a prn, so not sure if northera can be used in that way.