Accutane, pre trials and the FDA

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Gabes-Apg
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Accutane, pre trials and the FDA

Post by Gabes-Apg »

for those that are interested

Tex - as per our recent discussions
interesting article about drug trials and Accutane

it is a shame that drugs like this are on the market for 10 years or more before someone gets an article published showing the link between the drug and dehabilitating side effects/conditions


http://www.drugwatch.com/news/2010/07/2 ... egligence/
One female participant in the trials who became pregnant while taking Accutane was pressured by the company to have an abortion in order to prevent awareness about the medication's risk of birth defects, according to one of the trial monitors. When Roche submitted Accutane to the FDA for approval, the company claimed no pregnant women had been exposed to the medication during the trials.

Opponents allege the company also resisted disclosing other important information regarding Accutane's questionable safety profile. Many contend Roche hid the results of a key study showing the medication increased the risk of suicide from the FDA, even though the FDA had already suggested that the company consider adding a suicide warning to the medication label.

And despite the fact that a potential association between Accutane and inflammatory bowel disease was first discovered in the early 1980s, many patients maintain they were never informed that the medication could cause gastrointestinal problems. In the Accutane prescribing information packet that spanned more than 20 pages, inflammatory bowel disease was granted little more than a paragraph.
Gabes Ryan

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tex
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Post by tex »

Yep, that one was pretty flagrant. It went on for a long time. I have a niece who used it, and about 2 years ago she was diagnosed with, (believe it or not), IBS. :roll: After her doctor's recommended treatment didn't help much, I convinced her to try the GF, DF, diet, and as far as I know, she is doing OK now, but I haven't seen her in a while.

Thanks,
Tex
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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Accutane

Post by JLH »

DISCLAIMER: I am not a doctor and don't play one on TV.

LDN July 18, 2014

Joan
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