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Reductil Gets FDA Review

Written by Stuart Stevens| Tuesday, 21 September 2010| There are 4 comments

Reductil is one of the most tested weight loss medications in the world

Following the controversy around in the use of the weight loss medication Reductil, (which is called Meridia in the US), the Food & Drug Administration have undertaken their own extensive review of the drug in order to determine whether they should follow the lead of the European Medicines Agency which has withdrawn the drug from sale.

reductil gets fda review

There is some good news for Reductil manufacturer Abbott Laboratories in that the regulatory advisory panel did not decide to pull the obesity drug and are in fact split right down the middle about what they should do.  The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee has sixteen members and eight of them voted to withdraw the drug and eight of them voted to enforce and label more clearly the existing regulations with careful monitoring of sales.

The reexamination of Reductil was initiated by the results of the SCOUT study which monitored the long term cardiovascular implications of sibutramine in 10,000 patients with already existing cardiovascular problems over a six year period. The SCOUT study showed that there was an increase risk of having a stroke or heart attack in these patients.

What everybody seems to forget however is that Reductil is not indicated for use by people who do have existing heart problems and must only be used by men and women in good health. Doctor Sun who is the head of global pharmaceutical development at Abbott explained that this vote highlighted the "complexity of this scientific debate" and said that he and the company he represented still believed the significant benefit of Reductil to treat people suffering from obesity.

Doctor Sun made a very relevant point when he argued that the SCOUT clinical trial did not look at the men and women for whom Reductil is specifically indicated i.e those who do not have any history of heart disease and only examined those who had existing heart disease who should not be using Reductil in the first place.

There have been over 100 clinical trials with over 20,000 men and women taking part making Reductil one of the most tested weight loss medications in the world. Reductil is a prescription drug because it is contraindicated for some men and women. The European ban on Reductil has led to a proliferation of fake Reductil products using poorly manufactured sibutramine being sold on the black market which is another reason why we hope that it will be reinstated for sale in the UK soon.

The FDA will have to make the final decision on whether Reductil can continue to be sold in the United States over the next few weeks.

© 2012 This content has been exclusively written by UKMedix [request source information]
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There are 4 comments on this article.

On September 23, 2010 @ 01:35
martyne said:
yes my point exactly! i read alot about this when my GP said that I could not get it from him anymore..but even he admitted the studies were nt fair..
I am not a patient with a pre-existing heart condition but I will be if I dont take my reductil and i put on more weight! I actually managed to get mine from reductil by mail in the end and got it checked by my doctor, he now recommend it to 'certain old patients'.

bring reductil back!
Separate Comment
On November 26, 2010 @ 07:19
Jess said:
pls, just bring reductile back!
Separate Comment
On January 09, 2011 @ 10:12
helen said:
anyone been able to purchase from reductil by mail recenttly? just been on and it's saying that the website is down due to work being carried out on its 'secure servers'
Separate Comment
On February 17, 2012 @ 13:08
kate said:
reductill saved my life but now I have put on over two stone again I wont go out of the house,my confidence has plummeted and my family are suffering.
Separate Comment
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