Misunderstanding symptoms and conditions

To clear up any misunderstanding about the FDA Singulair investigation.
FROM THE FDA STATEMENT ABOUT THE SINGULAIR INVESTIGATION

"FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton."

"although (the clinical trial) data do not suggest that montelukast, zafirlukast, or zileuton are associated with suicide or suicidal behavior, these clinical trials were not designed specifically to examine neuropsychiatric events. As a result, some events may not have been reported."

The FDA is continuing to investigate a link between Singulair and suicide .
They stated that they have not "closed the book on suicidality". Any news reports stating there is no conclusive link are incorrect.

My wife had Mirena inserted last year around May. Side effects were similar to those detailed here. Non-existent libido. Acne. Consistent with other's reports of joint pain, my wife experienced symptoms that were diagnosed and treated as Lyme disease. At the time we wondered how it could be Lyme disease when the doctor reported that several tests for Lyme disease came back negative. Now we wonder if the joint pain was actually the Mirena.

After reading the comments on this site, we had the Mirena removed in late May, despite a skeptical doctor. A week of uncomfortable heavy period, but not to bad. My wife's libido has returned, her face has cleared up, and I've gotten a vasectomy.

best wishes, Jim in VA

I just got a very condescending private message from a doctor on this site who said that while my articles from Europe are very helpful that I don't know what I am talking about and that I could mislead the public. Then I see how many parents and patients got a condescending attitude from their own doctors.

Well the public has been mislead but it is not my fault. I don't see any experts in this field stepping up to the plate to acknowledge that these side effects exist, have been reported by authorities in other countries, and that these experts are interested in learning why they are happening. This is an extremely widely prescribed medication that involves the lives of millions.

Merck's research director was quoted as saying that they know of no mechanisms by which these side effects could be related to psychiatric adverse drug reactions. That was a flat out LIE. So what if I quoted you a research article from China that was very complicated and yes, could possibly be misinterpreted by somebody? I just needed to give you an example. The only expert so far that had the guts to give you a truthful statement was Dr. J. Douglas Bremner. Thankfully, he corrected a misunderstanding about saying that it was "unclear."

I hope that we will all hang in there and something will be said by somebody, anybody on this site that will make the FDA listen and investigate Singulair (montelukast) all the way back to the very original studies done in test tubes not on people. And, then take a new look at it from the standpoint of what we now know about human genetics. I guess I will keep repeating myself about one size does not fit all.

I would also PRAY that all clinical studies on Singulair (montelukast) would be suspended until the FDA decides why these side effects occur. And that they would issue a statement to doctors to make conservative decisions regarding treatment with Singulair until the results of the investigation have been reported.

I hope that nobody thinks that I am trying to mislead anyone. The answers are either unknown or being hidden by Merck. How would I know the answers? I don't work for Merck. How many other people are out there trying to translate articles in foreign languages to see what's going on? American doctors are calling Merck and being assured that there is nothing to these claims.

I wonder how many experts there are that just don't want to be another Jeffrey Wigand or don't know what is wrong?

I know that I am ranting but somebody should do it.

Some of these stories read like a diary of our life.our son went from a reasonably confident, happy, somewhat easy going 10/11 year old to a now 16 year old with no confidence, somewhat paranoid, dealing with depression and tremors so bad that he could not hold his pencil to draw a straight line in drafting. He often says he hates his life, can't see any hope for the future and feels he is a failure- he is an honors student with a nearly perfect 4.0 average, yet he is never sure it is enough.

some of it we put down to being a teenager, who had inherited hubby's fathers shaky hands. some we figured came from my dad and his troubles with ocd and depression. i have worried, cried, prayed, ranted and begged for things to be different for him.

what changed at 10/11 years of age? he started taking Singulair. at first a low dose but about 3 years ago the doctor uped the dose to full strength, the symptoms also escalated - however he had entered the teenage years and changes they go through.

the allergist last year,put him on Pulmicort and at that point did not need the Singulair but through a misunderstanding we kept giving it to him. hubby is a pharmacist and questioned it, he has never been wild about Singulair because he says it opens you up to infections.

which may answer a secondary question of why he has had more cases of bronchitis and has had 3 bouts with pneumonia, more since the dosage was raised.

i have to wonder if the history of depression in our family made our son more open to the symptoms and side effects of the Singulair. the suicide part of it really scares me as my uncle and aunt both committed suicide, we didn't need any push in that direction. we have talked extensively about it and he assures me he does not consider it an option.

i know some kids take it no problem, but this recent set of reports, and the fact that the FDA has changed the warning labels 4 times in a year, causes me to take notice for him

please pray that we can see some improvement as he is now off of the Singulair. I stopped mine last year due to recurring ear infections. now i am especially glad i did. i have felt very hopeful today that this may be an answer to prayer. two days off and he had a good day today.

Hi again. I think some readers may be misunderstanding what I am talking about when I posted my story and talked about natural progesterone. Natural progesterone is a bioidentical hormone derived from plants. It's only side effects are that it may make you sleepy, and it may calm you. It is NATURAL; I am not talking about synthetic hormones like in BC pills or HRT. You can buy natural progesterone cream in any health food store OTC. I happen to have mine compounded into a capsule in a compounding pharmacy. Natural progesterone and other bioidentical hormones are not manufactured by the pharmaceutical companies, and are therefore, not pushed by doctors. You will not hear about them from your general practitioner or your OBGYN. They are generally recommended & prescribed by holistic & wellness minded physicians. Dr. John Lee is a famous author who has written many books on the subject if you want to research him for more information. Or just google bioidentical hormones for more information. I just wanted to clarify what I was recommending. I think some of you just heard "hormone" and got scared. I totally understand. I think synthetic hormones are evil too. My friend and I have been suffering from anxiety as the result of Yasmin for a few years now, and we have tried several things together trying to recover ourselves. This is the only thing we found that works for us. I'm not saying it is the answer for everybody.

Mydaughter is 8 and in second grade. She has been diagnosed with adhd. We have been taking adderall xr for about a month and a half. While the school day goes well for her, the afternoons and ugly for us. She is very agitated, cries for nothing and irratic for about 1-2 hours. We also have a hard time getting her to sleep. Her doctor prescribed Lunesta 1 mg, but it takes a long time for her to go to sleep. We start around 9:00 or10:00 and it takes a good 1 1/2 hours to get her to go to sleep. She does not sleep thru the night either and has never been a good sleeper. ALong with this add she also has hydrocephalus. While this works great for her attention problem in school, it is very exhausting for me in knowing how to handle her moods, outbursts and the sleep issues. Any advice on either? Thank you