Clinical trial FDA links

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Drug and Device Information from the US Food and Drug Administration

http://clinicaltrials.gov/ct2/info/fdalinks

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Index to Drug-Specific Information

http://tinyurl.com/yjon665

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There are studies being done with Zileuton and Gleevec to treat leukemia, but

not yet in trial, so you may be hearing more about this drug trial soon. The

two drugs are already widely used to treat asthma and CML, so we may not have to

wait too long before the first trial begins. They are talking about a possible

cure. There are trials now where long time Gleevec users who are PCRU are

taking a vacation from Gleevec, under the supervision of their CML specialists.

No one should try this on their own unless you are used to playing Russian

roulette.

http://clinicaltrials.gov/ct2/show/NCT01130688

" The leukemic stem cells (LSCs) are cells that self- renew and give rise to

leukemia. Eradication of LSC is required for cure. In chronic myelogenous

leukemia (CML) LSCs are not eradicated by imatinib (Gleevec) alone. Recent

discovery by Dr. Shaoguang Li at University of Massachusetts indicates that the

LSCs can be targeted by a new drug zileuton (Chen et al. Nature Genetics 2009;

41:783-792). Zileuton (approved for asthma) will be tested in a combination with

Gleevec. This combination has not been used previously to treat leukemia. This

is a Phase I study. The goal of this research is to evaluate the safety of the

standard anti-cancer drug imatinib and experimental drug zileuton. " Last

Updated: September 9, 2010

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We spoke of this on Skype this evening. Zyflo and Singulair is in the same

class of drugs and I found this regarding warnings about these drugs.

I took Singulair for some time and never had side effects from it, so I would

think that the incidence of having many of these sides effects would be small.

Side effects seem to affect me more often than average and Singular gave me no

problems.

" Neuropsychiatric events have been reported in some patients taking montelukast

(Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has

requested that manufacturers include a precaution in the drug prescribing

information (drug labeling). Montelukast is used to treat asthma, and the

symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the

nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are

used to treat asthma. The reported neuropsychiatric events include postmarket

cases of agitation, aggression, anxiousness, dream abnormalities and

hallucinations, depression, insomnia, irritability, restlessness, suicidal

thinking and behavior (including suicide), and tremor. "

FYI,

Lottie Duthu