Actually, I think they made a good move, myself. It's not only the risk of drug abuse but they didn't have data about drug interactions for people that take other meds. Most of us do take other meds. That would be quite frightening to think a drug could be approved without knowing interactions. Anything could happen.
Also they were worried about risks for patients with multiple coditions and also problems with the complex dosing. There could be abuse...even accidental. Many of us are suffering with other illnesses besides fibro so this is a protection for us.
I went to a weight loss doctor 40 years ago and he put me on a weight loss medication called escatrol. They no longer make it because it became a street drug. It was an upper but I didn't realize it. I knew nothing about those types of drugs but just blindly trusted my doctor. Also, even though I took it according to the script...one a day....I did become addicted to it. I know I wouldn't want to have that happen again.
So, I do agree with what the FDA did. I'd rather they take their times with approving medications than rushing things through that people get sick or even die...like Vioxx.
Thank you, though, for the article! This gives me more hope that they are really working on finding things to help people with fibro. So even though this drug wasn't approved, something might come along soon that meets a more strict criteria.
Sherrine