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Reporting serious problems to FDA

Posted: Sat Jun 25, 2016 3:44 am
by degan
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.

Re: Reporting serious problems to FDA

Posted: Sat Jun 25, 2016 8:02 pm
by ViewsAskew
Thanks for that. Definitely something we should all do.

Re: Reporting serious problems to FDA

Posted: Sun Jun 26, 2016 2:31 am
by degan
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.