Reporting serious problems to FDA

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degan
Posts: 5
Joined: Wed Feb 03, 2016 3:53 am

Reporting serious problems to FDA

Postby degan » Sat Jun 25, 2016 3:44 am

Just wondering if anyone has reported their experience of augmentation and/or weaning off Dopamine drugs to the FDA. It can be done online at fda.gov or by calling toll-free (855) 543 3784

Earlier in the year I reported an issue when my insurance company switched to mail order and the medication I received definitely wasn't the same pill I had been taking for the last few years. Although the name and dosage on the container was correct, the medication gave me severe nausea and lightheadedness and did not work at all (spent the ENTIRE night pacing up and down with severe RLS symptoms). After some research I found that the manufacturer was different (mail order company used Mylan Manufacturing). As mentioned I reported the issue to the FDA and actually got a letter in the mail from them requesting that I complete a one-page questionnaire and send it with the medication to Mylan to investigate further.

Based on my experience earlier this year, just thought it would be worth mentioning that serious problems should be reported.
Hey you never know...might help.

ViewsAskew
Moderator
Posts: 15775
Joined: Thu Oct 28, 2004 6:37 am
Location: Los Angeles

Re: Reporting serious problems to FDA

Postby ViewsAskew » Sat Jun 25, 2016 8:02 pm

Thanks for that. Definitely something we should all do.
Ann - Take what you need, leave the rest

Managing Your RLS

Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

degan
Posts: 5
Joined: Wed Feb 03, 2016 3:53 am

Re: Reporting serious problems to FDA

Postby degan » Sun Jun 26, 2016 2:31 am

Wouldn't it be great if everyone who experienced augmentation made the FDA 'aware' of it? If you have any suggestions of how my dream can come true PLEASE let me know. Not sure how I can get the word out to other members :)

Maybe I'm too optimistic, but if the FDA heard all the horror stories I read from RLS sufferers about augmentation, maybe they would take it seriously and make some change.


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