FDA Proposal to Remove Midodrine from Market

[Andrew]

From the IACFSME

Dear Members.

The U.S. Food and Drug Administration has proposed removing ProAmatine (generic: midodrine) from the market, saying the required follow-up clinical studies haven't been conducted. The indication for use of midodrine hydrochloride is in the treatment of symptomatic orthostatic hypotension. A number of patients with CFS/ME say the drug helps them.

For more information, the FDA websites are:

www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm

www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222640.htm


Thank you.

Fred Friedberg, PhD
President
IACFS/ME

Here are some references about the drug, taken from Broken Marionette

Duschek S, Hadjamu M, Schandry R. Enhancement of cerebral blood
flow and cognitive performance following pharmacological blood pressure
elevation in chronic hypotension. Psychophysiology. 2007 Jan;44
(1):145–53.

AACFS conference January 2001. Report by Dr. Rosamund Vallings.
http://www.cfs-news.org/aacfs-01.htm

Naschitz J, Dreyfuss D, Yeshurun D, et al. Midodrine treatment for
chronic fatigue syndrome. Postgrad Med J. 2004 Apr;80(942):230–2.

Naschitz JE, Rosner I, Rozenbaum M, et al. Successful treatment of
chronic fatigue syndrome with midodrine: a pilot study. Clin Exp Rheumatol.
2003 May–Jun;21(3):416–7.

Goldstein Jay. Tuning the Brain: Principles and Practice of Neurosomatic
Medicine. Haworth Press 2004. p. 93.

 

[ahimsa]

This is going to affect a lot of patients in the USA. I think I read in one article that there were about 100,000 prescriptions for midodrine last year?

Here's an interesting analysis of the conflict between the business issues and the FDA regulation rules:

"Pill pickle: Hypotension drug quandary spotlights tough FDA's dilemma"
http://www.theheart.org/article/1113069.do

For those who are taking this drug and who want to take action the Dysautonomia Youth Network of America web site has an "urgent call to action" web page all about contacting the FDA:

http://www.dynakids.org/midodrine.jsp