Clinical trials symptoms and conditions

I just want to reply to you and everyone else who is having difficulty with doctors acknowledging mirena side effects. I work in pharmaceutical research and what people need to understand is that clinical trials only test on samples of about 5,000 patients and the side effects observed in those people are the ones acknowledged in the literature your doctors are referring to. The problem with that is for a drug sample population to statistically represent the actual US population it would have to be at least 30,000 people. This is not feasible even for the most profitable big pharma companies. So once these drugs get to market, there are inevitably going to be people experiencing side effects not reflected in clinical trials.

That said, I had Mirena put in 6 weeks after giving birth to my son in August 2008. Pre-preg I weighed 132, at 9 months I was 173. I left the hospital weighing 152. When i got mirena inserted i had been loosing slowly due to breastfeeding, but I was loosing and weighed 145. By Christmas 2008 I weighed 155. So I started working out, circuit training 45 minutes, 5 days a week, and eating much healthier for 6 weeks. Like others assuming it was a change in lifestyle, stress whatever. I didn't loose a pound. After no success I cut down to less intense workouts but kept eating well. By June 2009 I was 163. At 132 lbs pre-preg at 5'4" I never worked out, I'm not kidding, ever and I was not a healthy eater, I just wasn't a big eater.

So August 10th 2009 at 168 lbs and fed up, I went to the doctor to have it removed. They insisted it was not the mirena, but if for no other reason I had to find out for myself why I could not loose weight, if i was still overweight afterwards then so be it, but I had to know.

I'm glad to announce that today September 21st, I have "inexplicably" lost 21 pounds in counting. I have not worked out like I did in those six weeks, brisk walks at the most,and I have continued eating healthy. I'm not advising anyone on what to do, I just know when I was contemplating getting this thing removed, I wanted to hear from someone who had actually gotten it removed. Also, I did not the emotional or dermatological side effects others described.

I have posted a couple of times previously about negative side effects, i.e. migraines, weight gain, acne, chin hair, eczema, lower back pain, no sex drive...and the list could go on. As a mature 36 year old woman I have educated myself over the past couple of years and can really only attribute all these issues to having the Mirena inserted 4 months after the birth of my daughter 3 years ago. Although at this time my doctors will not openly acknowledge these side effects, I am confident that one day they will. I encourage women to report adverse side effects to the FDA. It onlt takes a minute or two. Who knows, it may be the hormones or it may be the silicone plastic? It has to be something. It should also be acknowledged that some women, my very best friend for one, have had wonderful experiences with the Mirena. I really think it may just depend on the woman and her own body. I am having mine removed tomorrow after researching all of this for about 8 months. All I can say is, thank goodness. I am also scheduled for the Essure(permanent birth control). Food for thought for the older women in the group. Whatever each of you decide, realize you are not alone and you do not have to continue to feel the way you do if you believe that the Mirena could be making you feel so bad. Take care.

My 11 year old son started singular in March of 2009 for exercise induced asthma. Within weeks he started having symptoms of heartburn - which he had never had before. I brought him back into the dr. mid June- they said wasn't related to singulair and actually increased his does from 5 mg to 10 mg. Since increasing his does, he started experiencing, daily headaches, stomach pain, leg cramps, night sweats w/ shaking & overall FEAR. Last night he was in tears - he kept saying there is something seriously wrong with me - I can't stand feeling this way he was afraid he was going to die and didn't want to go to sleep.

Last night I did my own research and found this board. THANK GOD!
He didn't take his singulair last night & he never will again.

I called his dr. this morning to tell them I think he is having negative side effects from singulair. They actually told he it was "HIGHLY UNLIKELY" his symptoms were related to singulair and NOT TO STOP USING IT. They instead said I should start giving him pepcid. I told them he had stopped it - for good and that we need a plan B for is exercise induced asthma. Looks like my plan B is finding a new Dr. that isn't in bed with Merck.

Has anyone had any experience with a NATURAL approch to controlling exercise induced asthma?

I just recently posted about my experience with mirena and had then read some more posts, and I had a thought. With SO MANY of us experiencing these symptoms-can't we do something about it?? Couldn't we send copies of these thousands of posts to Bayer or whomever is the top of mirena, I think it's Bayer. Or someone who can help us! Obviously we're are not all crazy! There is obviously something going on here. I mean I want to make sure other women are aware that this product may not be the greatest thing in the world. Anyone else who has a thought on this msg or reply please.
Thanks for listening!
And blessing to all.

I am 51, when I was a child I had asthma and it went away in my twenties. Yesterday the doctor told me I have asthma and allergies. I took 10mg singulair last night, today I have a sore throat. Is this a temporary side effect that will eventually go away?

Has anyone been in contact with any doctors, hospitals, or researchers who are willing to recognize that Singulair targets a receptor CysLT1, with known genetic variations? As you know, I have been posting that I know of researchers who are doing work about how the genetic variations can determine the efficacy of Singulair. If genetic variations cause differences in efficacy, then, of course, these variations can also cause unpleasant to very serious side effects. These seems to be some kind of disconnect. How can the genetic component be recognized in the area of efficacy and ignored in the area of adverse drug reactions?

I have been on Singulair longer than I can recall... at least 10 years, maybe longer. My 7 year old son has been on it since he was probably 12 months old. Neither one of us have had any problem reported here. No depression, no sleeplessness (until I weaned him from naps, he slept up to 13 hours a day), no leg cramps, nothing. We are two of the happiest, most well adjusted people you could know. And, best of all, we haven't had any asthma attacks. Bottom line, different drugs react differently in different people. Don't let the post here stop you from trying a medication that for some could mean the difference between life and death depending on how asthmatic they are. As with any drug recommended by your doctor, try it. If you experience adverse reactions, stop it ASAP. It's that simple.

I am a male in my 30s and I am predisposed to situational anxiety hypersensitivity and phase of life triggered depression. 90% of the year I am fine with no problems with depression or anxiety. I have had 6 treatments of amoxicillin over the last 2 years for sinus infections and wisdom tooth extractions. In each case, within 72 hours of the start of treatment, I experience constant depressed mood and hopeless and experience evening crying spells as a release from severe depression all day. In all 6 cases, within 48 hours of the last dose of amoxicillin, the depression subsides and my mood reaches a normal state. My doctor at the time did not attribute the depression to the antibiotic since I suspect it isn't listed in his PDR and did not show up with statistical significance in clinical trials. I don't go to that doctor any longer due to this and have a new doctor that has 20 years of experience and noted a lot of anecdotal evidence of amoxicillin triggering depression in those that might be predisposed to situational anxiety, panic attacks and/or stress/phase of life induced depression.

I started taking Yaz about a year ago. I started taking it around the time my brother died in a car accident. I thought that my loss of libido, tiredness, lack of interest in everything, emotional outbursts, arguing with my husband for any reason, crying over nothing, unable to concentrate while studying and unable to remember a thing were all because of my brothers death. I am now thinking that this may be due to Yaz. Does this sound like Yaz side effects? or am I suffering from depression because of my brothers death. I just haven't felt right lately and I cant figure it out.

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.

This drug has not been properly examined in clinical trials. I will gladly suffer with allergies rather than suffer from anxiety and panic attacks caused by Singulair. It may be beneficial to some people, but not to me. Never again, Singulair.

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.

My 6 1/2 year old daughter has been on Singulair for 3 1/2 to 4 years now and we have had horrible experiences! She was having night terrors, mood swings, angry issues, self control issues, crying over small things, etc. We have been to psychiatrists and psychologists who have diagnosed her with mood disorder, sensory processing disorder and anxiety disorder! Well she has recently been having stomach problems so we have been going to a GI to figure that out. I got online to research and found numerous sites that told how Singulair causes all these things in children. We took my daughter off the meds and within 3 or 4 days seen a tremendous difference! She is a totally different child! It just really frustrates me and saddens me that all these children and their families are going through all this and the doctors do not seem to care. The allergist or psychiatrist didn't believe me. They say no study has ever proven such things. I don't care what they say we as parents know our children and we are the experts when it comes to seeing how they change when on this medicine, we are the ones that live with them and are with them everyday not the doctors! I think they just don't want to lose out on their money from prescribing this drug 90% of children with allergies and asthma!

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.

I am totally upset by reading the posts here. my son is just now 8 months old. he was put on singulair when he was just 6 months old. at first it seemed to be working...for maybe 2 weeks...then everything went crazy. he was started out on it when his pediatrician stated that he had asthma and apparently was on a very high dosage of it. they started him on 10 mg of the oral granules. before taking it he was a very happy baby, even with him being so young i never had any problems with him crying excessively or being massively irritated. since he started on the medication he has had massive irritability spells, constant fussing and crying and cant seem to fall asleep at night let alone stay asleep very long. i had taken him to the emergency room on christmas eve because a new problem showed up. he now was having a massive hard time breathing, he had a persistant cough, congestion in his chest and was almost always gasping for air. the staff at the hospital were in disbelief when they were informed that his pediatrician had put him on singulair at such a young age and at such a high dosage. i am now in the process of obtaining a lawyer and filing a lawsuit against the pediatrician for medical malpractice. this drug is very dangerous for anyone especially children. i would suggest anyone else having these problems with their child and this drug do the same. it can apparently cause long term lung damage, pulmonary disorders and even death. my son has been off of the medication since christmas eve and has already done a massive turn around. he sleeps well and through the night again, his breathing has improved and his cough is almost gone. they did say in the E.R that he has congestion in his chest due to the singulair but it should clear up over time with the help of zyrtec. please help make a stand and protect our children from the dangers our own pediatricians present to them.

My 3 year old daughter was put on Singulair for her asthma and supposed allergies. I did not notice any behavior issues, but when I read the very very fine print saying that it could cause stunted growth AND had had no clinical trials in children, I took her off. I have cured her asthma with herbal supplements (a combo that fights bronchial inflammation ans desensitizes the liver to minimize/eliminate allergic reactions - from GAIA labs, look up asthma/bronchitis / allergy). She is now 11 and has not needed any treatment of any kind for at least 6 years now.

About Singulair and being INCOMPATIBLE:

Merck acknowledges that there is a certain percentage of patients for which Singulair is "NOT EFFECTIVE" because of incompatibility issues. That problem is "all over" the research reports and clinical trials. Merck is even conducting research trials to try to determine why.

The issue of being incompatible as the reason for negative adverse side effects is not recognized as of now.

WHY? If Merck can recognize that Singulair is not effective or some patients, why doesn't it recognize that for others it causes negative side effects???

A series of articles published by the Boston Globe in 2001 revealed

that the number of children enrolled in clinical trials in 1997 was

16,000: by 2001, the number reached 45,000. The Globe found that children

enrolled in clinical trials had suffered and died, and that ethical

standards had been violated.

Financial incentives for parents, physicians, and researchers had undermined

children's welfare. Children are currently being recruited with Toys

'R Us gift certificates. Parents in need of money are offered as much

as $1,000 to "volunteer" their children for drug experiments that involve

risks of harm. The physicians

who are engaged in such coercion receive as much as $5,000 in kickbacks

(euphemistically called, "referral fees") for the recruitment of children.

None of these disturbing facts were brought to the attention of the

U.S. Congress when it passed the Best Pharmaceuticals for Children Act

in 2002. The evidence, however, shows that children are being deprived

of existing, more protective federal regulations under 45 CFR 46, Subpart

D, and are being subjected to foreseeable risks of harm and discomfort,

often on the basis of a presumed potential risk for which there is no

empirical evidence. The FDA

acknowledged that before FDAMA the use of children as subjects in phase

I safety drug studies "had been primarily limited to life threatening

diseases and children who had the disease" in question.

The policy prior to FDAMA protected children from harmful experiments

in accord with the 1983 federal regulations (45 CFR 46.404-409). Following

passage of FDAMA, however, federal policy broadened the criteria for

inclusion of children in research generally and for participation of

children entered in high-risk experiments. In 1999 the FDA acknowledged

that the post-FDAMA policy change "led to an increasing number of proposals

for studies of safety and pharmacokinetics, including those in children

who do not have the condition for which the drug is intended."[64

YOU have to get together and fight for change,the big pharm companies are running the show,they just about have diplomatic immunity,they can pass out poison and not be held accountable,change needs to happen,write everyone your congressman,your rep,they are supposed to work for the people.Somebody has to be made accountable.Pharm companies get to police themselves,they are in charge of their own clinical trials,it is a for profit business both for pharm companies and the clinics running the trials,nobody has your best interest at heart only their bottom line.Even the fda gets a bonus...IT IS WRONG

Thanks for the update Kate,as we wait with interest in what Merck has to say,I hope it is not a repeat of the Lung Associations report.To review past clinical studies,i dont know feels crazy,to ignore post marketing reports,well ignorant.My fear is after making my report to the FDA,that was the end of it not one follow up for further information,not one question on how our recovery was continuing nothing.All my letters to my congressman not one reply,i did not ask for a reply,but if someone wrote to me as often as i write,i would at least want to rule out stalking.Clinical trials are what they are,they are for profit,and not the profit of the participant,but profit for the companies and clinics holding trials,this by itself is a conflict of interest.We must continue to demand change the very future of our children demands it.Those of us who have seen the ravages of this drug must still shout out till we are heard our experiences do count no matter what the out come of this investigation.Good luck to all keep fighting

Just read an FDA article out today, I believe. The FDA is looking to publish quarterly a list of "potential problem drugs". That is fantastic! But where will this information be posted, and how often should a medical prescriber visit and hunt for such information?

I still maintain every medical professional with the appropriate credentials to prescribe any medication should be required to register with an email address with a database within the FDA to immediately communicate this new-found quarterly list, as well as any investigations launched (as with Merck/Singulair). Wow - what a concept.

I suppose I should be somewhat more optimistic with a slight move in the right direction - but I know with all my heart neither my daughter's pediatrician, nor my personal intern will receive, nor be aware, of any of the quarterly "lists".

Will keep trying to get a change within the FDA.

I am currently 58 years old and lead a very active, healthy lifestyle. I began taking 10mg of Zocor, along with 1000mg of niacin in the summer of 2004 to reduce cholesterol (251) and triglycerides (571). The therapy dramatically improved my blood tests, however, within 6 weeks, I began to experience minor chronic skin infections, both fungal and bacterial. They were easily controlled with topical over the counter type medications, but they were annoying. At no time was this new condition linked to the statin/niacin therapy by my doctor(s). The infections became progressively worse over the next 3 years, and evolved into chronic folliculitis in my scalp, neck, and face, cystic acne, and persistent fungal infections that were becoming more difficult to control. In addition, I began to get chronic eye infections. It was as if my immune system was becoming ineffective. I stopped taking niacin in December of 2007 and the symptoms immediately lessened. I stopped taking Zocor in March of 2008 and within 2 weeks, all the skin problems and eye infections completely ended. My health was restored completely and I am glad to have put that whole mess behind me! I have been taking Omega 3 supplements to control my cholesterol and triglycerides and have had results that equaled the Zocor and Niacin therapy, with cholesterol at 160, triglycerides at 91, and a favorable HDL/LDL ratio. My physician is skeptical, but I know that my body was not functioning correctly with the statin/niacin treatment. I have found anecdotal reports from others who seem to have experienced a change in their immune system, but no mention of this as a side effect by the medical establishment.

I've never responded to a site like this, but now feel compelled to. I had my Mirena fitted 13months ago, after a friend recommended it on the strength of her excellent experience with it. I was on anti-depressants already, so haven't felt an overwhelming sense of depression, but have been thinking for the past 10 months or so, that I get way more tired, have an overall achy body often, painful joints and swollen ankles. All stuff I never experienced before. But the thing that really did it for me was the weight gain. I was only slightly over normal weight at the time of insertion but have been gaining weight steadily. Initially I thought it was just a bit over over-indulgence, but after weighing myself last week, I've made the horrifying discovery that I've gained 13kg in 13 months!!!!!!!! I've never fluctuated more than about 4 kg in my whole life, eat healthily and am normally active. Nothing has changed to what I was eating/doing before. I specifically searched the internet today to see if weight-gain is a problem. It's not listed as a major side-effect on the 'official' sites, yet I see it on many of the postings on this one.
And for those of you who are into alternative therapies, I had myself checked with a kinesiologist for dietary intolerances/allergies that could have caused this weight issue, and what came up is that the problem is progesterone. When she checked if my Mirena was a problem for me, it came up VERY positive. When checked if I should have it removed, the response was equally positive.
It's a pity, as I had none of the other problems mentioned and it's such a convenient method of bc. But in my case it's coming out, before I have to come out as a seriously obese 41 yr old!!!!!

I have been reading all of these posts and have another question. I hope that someone can help. My daughter, 8 years old, has been on Singulair since she was 4. She is normally a very happy girl with a wonderful disposition. For the last year or so, she has been having trouble getting herself to sleep at night. She says that she hears things in her head such as ringing or "noises". A few hours before she knows it's bedtime, she cries and when we ask her why she's crying, she can't give us a reason. We initially thought that she was crying for no reason because she didn't want to go to sleep. I remember reading about the side effects of Singulair causing mood swings, etc., but her's are not violent mood swings. Just very emotional and has a hard time coming down from the "episode". I'm at a loss...I have not talked to her doctor yet about it, but have told her that we will make an appointment this week to discuss it with him. My husband suggested that maybe it sounded like she was having a panic attack or anxiety attack. I hate to label her as that at such a young age. My mind now goes back to the side effects of Singulair and maybe this is to blame. Any help or suggestions would be greatly appreciated. Thank you! Concerned Mom