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Phase ii symptoms and conditions

Here are side effects posted by other members, that mention phase ii.
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50 Side Effects posted for phase ii

January 17th
2009
8:02 PM

Science has NOT conclusively ruled out a link between Singulair and suicide. In fact, science DID reveal a link between Singulair and depression (a risk factor for suicide). In the clinical trials one montelukast participant dropped out and the investigator cited the reason as depression that was "drug related". Additionally, in the primary and Phase II/BIII Studies, 12 out of 1955 participants taking montelukast reported depression, vs. 5 out of 1108 on placebo, and 1 out of 251 on beclomethasone. This information is presented in the FDA's medical review for Singulair and is available on the FDA website. Depression was not only reported post-marketing as some would like us to believe. As the FDA explained in their update to the investigation, Singulair's clinical trials were not designed to measure neuropsychiatric events so some may not have been reported. Using clinical trial data to prove that Singulair cannot cause a particular symptom or outcome is as foolish as discounting post-marketing reports that show that some neuropsychiatric events associated with Singulair are consistent with a drug-induced effect.

-- By ms76 | Reply | (1) replies | Private Message me

January 16th
2009
4:49 PM

I am 34 years old. I am a pharmacy tech. I have asthma and allergies. I have taken singulair pretty much every day since it came out on the market. I've had asthma since i was about 10 years old. I took theophylline as a kid. Steriods on and off especially during times when my allergies are bad. I still use Advair during the fall and spring. Every drug has a side effect. However breathing is pretty good damn thing. Do I have days when I feel low? Yeah. Do I sometimes have nightmares? Yup. Are "natural" products the answer. Not always. The fish oil that some of the posters are touting can also cause GI problems. Some of the natural products contain herbs and other plant derivatives that can be harmful for a child that suffers from allergies. Not proactively treating asthma can be deadly. Some of the parents are suggesting steriods as the answer - those can cause weight gain, growth suppression and can lead to a worsening of asthma.

Singulair has never made me feel like I've wanted to kill myself. I was more depressed and angry as kid when my asthma did not allow me to partipate in normal childhood things. I was sad and hated life when I couldn't keep up with friends at recces because I was having trouble breathing. You have to outweigh the costs with the benefits. I am more irritable when I have asthma flareup then I am on a normal day. For me, I choose to breathe. And singulair has been helping me for almost a decade.

I'm not saying the medication isn't causing these symptoms but maybe there is an underlying cause to your child's depression.

Any drug has a side effect. But without medical research and the medications that come with them - people would still be dying of simple diseases and we wouldn't have vaccinations. As a society, as a whole, we are a culture that looks to someone else to fix things and then blames the people who try to fix it. We need to stop being the "hot McDonald's coffee'" society.

-- By vabenavidez | Reply | (23) replies | Private Message me


 

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