Marketing symptoms and conditions

I have posted a couple of my feelings of the Mirena recently, including the fact that I might be pregnant (after having the mirena over a year) ..... but before now, I thought I was losing my mind in regards to me being irritable, losing my temper, moodiness..I was going to make an appointment with my doctor to get on a anti-depressant. Now, after reading all of the posts on this website, it may be all attributed to the Mirena use. Are the executives of those that market the Mirena or those regulating the use of this contraceptive reading any of our posts? Maybe they should. I am extremely disappointed. If I am pregnant, this is life changing. Think that Mirena should change their marketing scheme to say that the mirena is only 85% - 90% effective, if that....

SINGULAIR'S LABEL HAS BEEN UPDATED:

The following has been added to the "Precautions" section of Singulair's label:

"Neuropsychiatric Events
Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking SINGULAIR. Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some post-marketing reports involving SINGULAIR appear consistent with a drug-induced effect.

Patients and prescribes should be alert for neuropsychiatric events. Patients should be instructed to notify their prescribe if these changes occur. Prescribes should carefully evaluate the risks and benefits of continuing treatment with SINGULAIR if such events occur (see ADVERSE REACTIONS, Post- Marketing Experience)."

I have been taking Singulair for one week now due to my exercise induced asthma and allergic asthmatic symptoms. I feel very stressed out and anxious and yell at my parents a lot. Also, I feel kind of paranoid, like I feel as if somebody is watching me at all times. It is scary because I've only been on it a week. Also, my face is red and blotchy and my acne has gone from very little bumps to full blown breakouts all over. I have a barking cough and runny nose now that the doctor prescribed it. When I cough I have a pain on my left side that feels like someone is stabbing me.

I feel like I am walking on clouds; I feel light-headed; I can't think straight/logically; I feel drowsy; I see strange images that are not really there; my stomach is bloated and I have severe, disgusting gas; and my vision is blurred. All this to kill my carpal tunnel pain? It's high time I get off of this poison. I suggest all of you do too.

On January 13, 2009, the FDA released a Follow-up to their March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair). Included in this update is the following information:

"Post-marketing reports of neuropsychiatric events associated with montelukast, zafirlukast and zileuton have been reported to FDA’s Adverse Event Reporting System (AERS). Most of the reports of neuropsychiatric events are associated with montelukast, currently the most commonly prescribed drug that acts through the leukotriene pathway. The clinical details of some reports involving montelukast are consistent with a drug-induced effect. Because of the paucity of reports involving zafirlukast and zileuton, assessment of a drug–induced effect with these is limited. Accordingly, at this time, patients and prescribers should monitor for the possibility of neuropsychiatric events associated with these agents."

I wrote about a year ago. My 17 year old daughter was suicidal and horribly depressed during the year she was on Singular. Her asthma doctor had seen this is girls her age and took her off it immediately. Turns out it was not even helping the asthma as she improved on only Asthmanex.
She got better after being off Singluar 2 weeks but was never the happy, outgoing girl she had been before she started. She is now suffering again form an episode of major depression.

Are the effects of this drug permanent? She got so much better after she stopped it, it was like I had her back, almost. She never made ti back the whole way.
I filed a post-marketing MedWatch adverse drug report form one year ago. It is the only way we can prove what is going on. I used to be a certified clinical research co-oridinator. The FDA can't know unless we tell them. Please let them know what a dangerous drug this can be.

I was given Singulair a week ago when I went in for bronchitis. I have noticed I do stay tired all the time & that I've become more disconnected from emotions. I am normally a very sensitive person, and it's not that its been an extreme change, but the change is there and I don't like it. I also have had to continue using my inhaler due to tightness that the Singulair does not completely get rid of for me. Yesterday, I was having dinner when my head just spun. I grabbed my composure and was ok as long as I stayed more relaxed & didn't talk a lot. I have terrible allergies and I knew that my bronchial tubes were constricted very tight & that was the cause for dizziness. This morning, my lips were starting to swell and I was starting to feel the puffiness in my eyes. I wanted to know if I could take benadryl w/ Singulair & came across this site. I took the benadryl I feel much, much better. Seems to me that if Singulair is supposed to control the tightness I would be getting better, Not worse. I have made up my mind to stop the Singulair & will contacting my doctor for something different to help with bronchial contrition.

Thank you all for sharing your experiences.
R. in Tx

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.

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.

Post-marketing reports of neuropsychiatric events associated with montelukast, zafirlukast and zileuton have been reported to FDA’s Adverse Event Reporting System (AERS). Most of the reports of neuropsychiatric events are associated with montelukast, currently the most commonly prescribed drug that acts through the leukotriene pathway. The clinical details of some reports involving montelukast are consistent with a drug-induced effect. Because of the paucity of reports involving zafirlukast and zileuton, assessment of a drug–induced effect with these is limited. Accordingly, at this time, patients and prescribes should monitor for the possibility of neuropsychiatric events associated with these agents..........................................This is the small print that is missing from some news reports

Oh my gosh. I am on this website because I googled "behavior issues with Singulair" Both of my children are on Singulair. One from as young as 5 months old. Both Pulmonologist, allergist and Internal med Ped. insisted that it was a safe drug. They aren't living with it. My 7 year old has taken it consistently for 5 years and recently upped is having behavior, aggression, insomnia and constant reports back from the teacher on his behavior. We had him psychologically evaluated and they found nothing uncommon to his age. All his issues are described in almost everyone of these side effect threads. I am just afraid to take him off and feel the blame if something serious happens. I am calling tomorrow for possible alternatives.

Just started today with 40 mg dose of Sortis (Swiss-branded Lipitor).
60-90 minutes later, I am very dizzy, sweating, funny taste in mouth.

I am done... no more. My cholesterol is normal, but recommended as complementary treatment with Glucophage, as I am very slightly diabetic.

I am still spaced out as I write this note. Called the MD to tell him that I the one dose is all that will enter my body.

My daughter had been on singulair from the time she was 8 yrs old until she was 14. This will sound as if I am a horrible mother but I just thought that she was a raging bitch. Without my knowledge, she stopped taking her Singulair for a few months and she became a different person. She was so sweet and loving. One night she came in my room having an asthma attack and I asked her if she was taking her meds, she admitted that she had stopped taking her singulair and I got on to her and immediately got her prescription refilled. Within a few days of taking the singulair she turned into a raging, screaming emotional wreck, a TOTALLY different person. I feel so bad that for 6 years of her life I put her on medicine that caused her to have screaming, uncontrollable tantrums, and severe mood swings that caused her to be miserable. It does seem to be the only thing that effectively controls her asthma symptoms but the emotional havoc that is causes her and the people around her is not worth the benefits. We have an appt. with her doctor to see what other options we have.

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

I was given 40mg Lipitor for elevated cholesterol. I took it until I started having muscle weakness .I am a retired nurse of twenty five years, and knew this symptom was not correct. So I stopped taking the medication and told my doctor of this.He did not protest in any way.My symptoms now include;two torn ligaments, sob,mental deficits, muscle wasting, night sweats, weakness,h/a's, and more. I have not taken Lipitor for two years now. Damage is done.My doctor said it should be out of my system by now. Is this a cover up?

I have been on Zocor 40mg for many years and doing fine with it, until my doctor thought it was not working that well, hence, switched me to Lipitor 10mg. After a few months I developed severe chest pain along with neck pain. It felt like it might have been a heart attack, but it lasted more than 24 hours. I was admitted to ER for 1 night in the hospital and released the following day. They checked my heart and found it was fine. They ran my blood work, chest x-rays, cat scan and checked my lungs. All O.K.!!! The next morning they told me I had Slight Diabetes and an Under Active Thyroid and thought Esophagus Spasms were the cause of my pain. OH yeah, I also told them it hurt more with each breath of air I took in rather than out. It did not matter to them. They gave me Protonix 40mg because they thought it would reduce acid reflux to the esophagus, thus reducing my pain. Furthermore, they gave me Synthroid 25MCG for my Under Active Thyroid. After about 10 days of these medication plus LIPITOR, I had a recurrence of the same pain. I decided to research and came across this Website. I stopped the Lipitor and the next day my pain was subsiding. By this evening, my pain is almost completely gone. I am scheduled to have an Endoscopy in about a week from now and I am hesitant. Are the pharmaceuticals and physicians in cahoot with each other. I can't believe I was required to take all these tests and even more tests before the pain started (EKG, Heart Monitor, Nuclear Stress Test, Heart Scan and Angiography). Did I forget to mention I was diagnosed with High Blood Pressure and put on X-Forge a few months before all this started, but I was taken off it because of side effects (dizziness, lethargic, and so on). I did research on X-Forge and it said to NEVER use it as a first method of treatment for high blood pressure. I also was having pain under my right armpit. WHY DO WE HAVE TO SUFFER LIKE THIS BEFORE ACTION IS TAKEN TO PREVENT THIS FROM HAPPENING TO SOMEONE ELSE. Well, I guess it's just the price we have to pay before we decide to do things OUR WAY!! GOOD LUCK TO ALL OF YOU! THANKS FOR THE POST! PS. Can't wait to see what my Endocrinologist has to say about me next month $$$$$$$$$$$$$$$$$$$$.

If you are taking this medicine, STOP! I took this medicine for about three months. I started to feel like I had a congestion. I cough lightly at first then into a hard cough which progressed into a hacking. My wife thought I was critically ill. I was spitting up clear congestion at work into my garbage can. This stuff is bad, I found this site and stopped taking the medicine. It took 3 week for the cough to subside. It’s been about 4 months, and I would say I am only about 98 percent back to where I started . About every 3 weeks I out of the blue start to slightly hack. I know one thing this is not a good medicine. When I started my BP was 138/109. My doctor told me to try this. Because of this medicine I could not do my job and my doctor never told me it was the medicine. When I told him he told me he didn’t think it was the medicine and prescribe some cold medicine

I was prescribed Simvastatin four days ago, against my wishes, as I had heard about the side effects of muscle pain and numbness in the joints and feet. However, what I had not expected were the terrible nightmarish dreams that followed. On the fourth night I stopped taking Simvastin as I was literally too afraid to go to sleep.
I then slept fitfully but did not experience the vivid and disturbing dreams of the previous three nights.
I shall ask my doctor for alternative medication. If she cannot offer me anything other than statins, I shall stick to Benecol and research further!

Jacqui M.

I was prescribed Simvastatin 40mg four weeks ago and had horrendous side effects almost immediately eg deep depression, diarrhea, bad stomach aches and night cramps in my legs. Last week my doctor prescribed Lipitor 10mg and I feel no better in fact probably worse. The worst side effect for me is the stomach aches and constant diarrhea and complete lack of appetite. There can be absolutely nothing in my stomach any more. Does anyone else have these symptoms? After reading peoples experiences on here I feel I should stop taking this medication immediately!

Karen

i am a male 48 years old and have been taking zocor for only one month now and started getting a lot of heavy headache pain, and nausea,sinus headache and not feeling of working. ever since i feel always tired and not been able to proform at work also i m constipating with no bowel movements .

I have been taking Simvastatin 20 mg. for about two and 1/2 months now. It really lowered my Cholesterol but I have been extremely fatigued and now I am getting really dizzy when standing up and having some nausea.

I've noticed that NBC and The Weather Channel appear to be two of the biggest advertisers of Singulair. NBC can always be sure to have one on during the evening news, at least here where we live, on our local NBC channel. There for awhile, I was logging what time, and what channel I saw the ad. The ad only lists the basic side effects that aren't even dangerous. Merck must be paying NBC the big bucks because they still haven't dropped it. I don't know, should we bombard NBC with letters of negativity or boycott or something to get their attention on this murderous drug?

While I do agree that research and public awareness of the possible side-effects should be done, there are some of us that take Singulair without negative side-effects. I have been taking it for eight years, since I was 16 and have never had any of these side-effects. There was a couple of months that I did not take it because of financial issues, and the only thing that I noticed was that my asthma and allergies were horribly worse. These were both relieved dramatically when I resumed taking it. Without it, I would spend my days in an allergy/anti-histamine fog not being able to breathe while still taking my inhaler 4+ times a day and several during the night. That is just the beauty and flawed nature of medicine: they work perfectly for some but for others the negative side effects outweigh the benefits. I am sorry that so many have had negative experiences with it themselves or in their family, but please have an objective attitude toward it. Some people need it to live normal lives.