Fda symptoms and conditions

I was only on 25 mg of Topamax for two months and had to stop due to the terrible side effects of mouth numbness, taste aversion and severe dry mouth. Unfortunately, the side effects have gotten worse and persisted now for six months after going off this medication. My personal thoughts: Topamax is the worst drug on the market, has negatively impacted my life, and my neurologist could care less. These symptoms are with me 24/7 and only mildly helped by expensive mouthwash and lozenges specially formulated for dry mouth. Actually, eating certain foods makes these symptoms worse and I am afraid this is permanent, but can find no scientifically plausible evidence to explain such lingering effects. If anybody else has experienced such long-term symptoms after going off this medication, please share.

Two years after taking Chantix a tumor was found on my brain. I also have the pain all over every muscle, bone and joint every day. Do not take risks like I did. I trusted the FDA, and Pfizer and now I regret being so trusting.

EVERYONE....LET'S HELP OTHER WOMEN FROM TAKING THIS MEDICATION AND REPORT THESE SIDE EFFECTS TO THE FDA. GO ONLINE AND FILL OUT THE FORM....IT'S EASY AND WELL WORTH IT! ALL OF YOU WHO HAVE EXPERIENCED THESE DRAMATIC SIDE EFFECTS KNOW THAT THIS DRUG IS HARMFUL

Get off this nasty drug. It has the most horrible side effects.Is there a lawsuit against this drug. If so I need to follow-up.I had,:
THROAT SWELLING AND LIPS SWELLING
EXTREMELY DRY ITCHY THROAT.
DRY HACKING HEAVY COUGHING CONSTANTLY(could not get sleep)
ENDED IN ACUTE TONSILLITIS WITH FEVER
after getting of the drug I had no more problems with coughing or respiratory infections.these side effects are common with this drug. Yet the docs are pushing it. What are the pharma companies giving thes doctors??I no longer trust doctors.

We believe the following are among the most important shortfalls in the conduct of research involving infants, children and adolescents:

Failure to examine alternative methods of obtaining needed information so that research involving risk for children is minimized. The goal should be to limit the exposure of children to trials that seek vital information that is "unprocurable by other means" - as mandated under the Nuremberg Code and as stipulated in current federal regulations - 45 CFR 46 Subpart D - which restrict the exposure of children to greater than minimal risk. Indeed, until the FDA adopted the "Pediatric Rule" in 1998, high risk, phase I trials in children "had been primarily limited to life threatening diseases and children who had the disease for which the new drug was being proposed." It is difficult to justify a shift in policy that will increase children's exposure to pain and risks of harm.
Inadequate review: failure to evaluate risks relative to existing empirical evidence of harm.
Failure to minimize risks, including psychological risks, or to justify them from the perspective of the child.
Absence of evidence-based guidelines for classifying research protocols "minimal risk," "minor increase over minimal risk," or "greater than minor increase over minimal risk."
There is a pressing need to examine cases that resulted in harm to children - and to draw policy recommendations on the basis of that evidence - so that we can avoid causing harm in the future. Such an analysis was carried out by the Advisory Commission of Human Radiation Experiments (ACHRE), and for that reason ACHRE stands apart from all subsequent ethics advisory committees whose recommendations were unsupported by evidence.
Absence of boundaries to limit the level of risk and pain to which a child may legitimately be exposed.
Pervasive conflict of interests of all involved - including, and especially, institutional review boards that have been shown to rubber stamp approval of harm producing trials.
Absence of an independent child subject's advocate to monitor his/her well-being.
Lack of accountability or enforcement of federal safeguards.
Lack of penalties for those who violate ethical standards.
................................................................................................................................................................................................................................i found this on the best for childrens pharma act websight,it was a letter of worry from several doctors

My 7 yr old daughter has been off of Singulair for 12 days now. The change in her personality is amazing. She experienced two nights of strange dreams and waking in the middle of the night. We put her back on Flovent once a day as a substitute. Her aggression and frustration went away within days. She is so happy and content with herself. I can see that she is no longer frustrated by emotions that she could not explain. She's silly, funny, happy. She no longer hates us, pulls her hair, or tries to slap herself because she's thinks she deserves it. She has been on the drug since she was 3-1/2. We were doing family therapy to try to help her. This is no longer needed. She's back to her old self. What a shame no one warned us of this potential side effect. I also wondered how I missed the news story since I just found this site in September 2008. The news story about Singulair came out in March - just around Spring Break. Since we were out of the country, I missed the news. Isn't that a convenient time of the year to break a story? I'm sure many other families missed the news.

Today is 4years exactly that Matt had his one and only asthma episode,that sent us done the road of singulair disaster,7 months of the drug now thanks to Kate who went public with her story.Each new day brings more hope for a full recovery,although the road is long and strewn with guilt and anger.First i was angry with my doctor,then Merck now the FDA,but the guilt always stayed with me.Ive spent hours on wouldas couldas and shouldas but none the less it is what it is.I have had an education in things i really didn't want to know,the medical system,the justice system,and our government.I have written hundreds of letters reported 3 times to the FDA,never a response other than your email was received,called and reported to Merck twice,they were always ready and willing to take my info,so today i wrote to the FBI asking if they could investigate corruption at the FDA,proberly they will laugh and trow it out,or maybe even put me on a list of some kind,but i will leave no stone unturned until some one explains to me how this happened in America

I have a 26-month old grandson who has been on Singulair for "27 DAYS". His pediatrician knows that his immune system is already compromised due to some developmental delays. However, before he started taking his Singulair he was a very happy, funny and loving child. Within 2 weeks on this medicine we started to notice a few changes in him. He started waking up at night "screaming" and he has been sleeping through the night for at least a year now. And when his mother would go in to get him out of his crib, he would be so frightened and afraid to leave her side. It would take her a very long time to settle him down and put him back down for the night. At the same time, he started not wanting to drink his normal daily glasses of milk or eat his regular meals. He was simply a mess most of the day and would fuss, cry, bang his head and we were having a very hard time trying to figure out what was wrong with him. He is not yet talking due to his delayed speech, so he could not tell us what was going on. Yesterday, I told my daughter let's look at the side effects of Singulair since it was the only thing that had changed within the last few months. When I found this site, I could not believe what the parents/grandparents were saying about their children on this drug. We immediately took him off Singulair. This will be his second day without being on the drug. According to my pharmacist, it will take approximately 50 hours for it to get out of his little system. The pharmacist had not heard the latest that aired on the TV station, so she asked me to call her back in a few days to tell her how my grandson is doing. Parents should be able to trust the medications that are prescribed by their Pediatricians, especially at such young ages. My daughter is REALLY UPSET and has a call into my grandson's doctor. Thank God I found this website. I simply searched on "side effects of Singulair in children" and this site came up. I do believe the Lord is watching over my grandson. Thanks.

Hi All,

I was diagnosed with dermatologists when I was 14 years old and put on very high dosage of prednisone to get my disease under control (40 mg a day at the beginning). My muscle enzymes were out of control (CPK was almost 8,500 when it should be s no control so I would suggest contacting doctors in Europe or Asia directly or through your doctor here in the states. Anyways, I wanted everyone to know that some people do get better and I wish you all the best of luck!

I have a 4yr old boy who has been on singulair for 5 months. Before he began singulair he was the most happy, kind, gentle, loving boy. We had an awesome close relationship. I enjoyed just sitting there watching him play. I could not wait for him to learn something new, but EVERYTHING has changed now. I took him off of singulair on Sept 19, 2008 after accidentally running into this site while looking up children and OCD. Thank God I did. It has been 12 days since I found this and took him off. I couldn't type then because I was to upset. My son who never had ANY mental problems or anxiety is now completely riddled with it. Instead of playing all day care free like 4yr old are supposed to do, my son spends his days now clinging to me in fear that I may leave or go into a room without him and he will not be there to open the door. He obsessively has to open every door now. He spends his days getting upset at the smallest things. He now gets mad at everything I say, or I don't say it right. Our relationship is not the same now, and I am devastated. Before Singulair he slept through the night every night. Now he wakes up every couple of hours to go to the bathroom and say "are you still there mom?" ok "I love you" "Don't let the bed bugs bite" I have to answer "I love you to" and "you either" If anything different is said he will go nuts, and he will obsessively say this over and over and over again. This is not my son. He is a totally different person. I am so very scared that this poison has permanently ruined him. I mean he is so young and his brain is developing. It has been developing with this poison in it, that has ruined him. It has been 12 days and he is still doing the same ocd stuff. He still seems really agitated. His muscles hurt, his tummy hurts, his eyes hurt, his ankles hurt, and he has diarrhea. My beautiful boy is now mentally and physically SICK because of singulair. I feel really bad to, because I did not know at first that the singulair was causing this and I was always getting on to him for his behavior and putting him in his room. At pre-school a couple of days after first giving singulair to him he started crying ALL DAY at school, and I made him stay there because I thought it was just because he had gotten a new teacher and he needed to get used to her. I feel terrible!! Does anyone know if the ocd will go away or has he now learned the behavior?

I have had the Merina for 4 years. I never had any problem with it...up untill now. Insertion was easy and my periods stayed regular. No problems at all. I even recommended it to all my friends. This last year I have had so much depression and phantom pregnancies. I keep thinking I am pregnant when I am not. I think my body is not agreeing with the hormones.

My friend had hers removed after 1 month due to weight gain.

My sister's started to fall out and now she is 6 months pregnant. She had it removed as soon as she found out she was preg.

I wanted to let you all know there is a link and phone number on the Merina website to report negative side effects to the FDA.

Hi,
I'm a 38 year old woman who went on Singulair in September of 2006. By December of that year I started experiencing heart palpitations,dizziness,and nightmares that stayed with me in my waking hours. By January of 2007 I was having full blown anxiety attacks. My doctor ran every test under the sun and I went to several therapists. By the end of January my doctor had me on Effexor, and several other short term aids such as atavan. The summer of 2007 I started experiencing stomach pains and sever diarrhea. As much as I loved my 20 pound weight loss, it was not a lot of fun. Again every test under the sun showed nothing. This spring I heard of the concerns of Singulair and immediately went off of it. Within a few weeks I felt like my old self. I am still weaning off of the Effexor and my asthma is not as good as it was on the Singular, but it is worth having my health and my life back. I feel that Singular almost ruined 2 years of my life. It should be taken off of the market.

I aged ten years in a month. My legs lost any muscular power and I needed help to get up our 3 steps to the front door. My eyes are sore and my balance is also affected. What I do not know is how long am I going to be affected like this. I began to think that I was starting with either motor
neurone disease or Parkinson's disease.
Muscle weakness, loss of balance, bad dreams,anxiety, irritability.joint pain.sore itchy eyes and difficulty focusing on printed pages.
A., Yorkshire, England.I am 69 years old and prior to Singulaire I was pretty fit for my age.

Wow- this floors me. My daughter is 20 now- we had her on Singulair for years for her asthma. She suffered from horrible leg pain, but she was a 4-sport varsity athlete and we attributed the pain to over training.

Her first year at college she started suffering from severe depression and lost a lot- I mean a LOT of weight. She went about a year and a half with no period due to low body weight. We wanted to check her into an inpatient treatment center for eating disorders but couldn't because she was over 18 and didn't want to go.

In June we sent her to a new allergy doc who retested her and switched her from Singulair to Symbicort as the Singulair was not managing the asthma well. It was like we flipped a switch- she stopped having vision problems, stomach pain, and insomnia almost overnight. She has gained back at least 10 pounds and is looking like her old self again.

I'm so glad we stopped the Singulair, even though it was accidental. A year ago, we thought we might lose our bright and beautiful daughter. We had no idea it could be as simple as the asthma med. I'm telling everyone I know about possible side effects of Singulair.

THIS IS A HORRIBLE DANGEROUS DRUG!!!!!
Doctors prescribed this to my mother for 5 years!!!! Because of it's devastating side effects it is FDA approved for short term 4-12 weeks and only as a last resort. And NEVER for Parkinson's patients. It is unclear if Reglan caused the Parkinson's like symptoms or if she had it prior. Either way the doctor was so wrong to prescribe this medication to her. She is completely disabled can't walk or even get out of a chair had a auto accident and falls one time a metal frame fell on her head causing a hospital visit another time she fell into cactus! I was horrified to learn that no one caught this error. Not one doctor or the drug store told my parents REGLAN could cause her to end up using a walker and unable to function even the simplest daily tasks and that these symptoms could be permanent.

If you google the words fda singulair side effects......the third result down is a link to the FDA's consumer information page on Singulair.......the information has NOT been updated since 2001. Why have they not updated this since 2001?

I am a loving mother of a 5 1/2 year old boy. He has been on Singulair for over 3 years. In this past 3 years my son has suffered in an unspeakable amount. He came down with Rota Virus and was hospitalized at 2. He then came in contact with Pneumonia in the hospital while he was there. They automatically put him on Singulair, Zyrtec, Prednisone, and antibiotics to treat the pneumonia. Since that day, my son has gone though more tests than I have in my entire life. He has had asthma, sinusitis, leg cramping ( to the point he cannot walk for 2 years), IBS, Acid reflux,(they gave him laxatives for a year that made things worse and addicted to them also), stomach pain, constipation and diarrhea back and forth. He also got Erythema Mulitforme TWICE, while on this drug. All of which the doctors said could NOT be caused by Singulair. He has had several Upper GI's and CT scans. Along with Barium enemas, several hundreds of blood tests, and many many pokes and prodded that were not necessary. All since he has been on Singulair. He now has frequent bathroom trips, depression, confusion, and anger outbursts. He also has to go to the restroom every 5 minutes. He has had genital swelling, and many other aches and pains. None of which his "doctor" ever said could be a result of Singulair. I am 100% sure it was!!!! He currently has anxiety and emotional sporadic issues causing problems in school The teachers and counselors say that it is so strange because there is no TRIGGER and the outbursts are completely inconsistent. His preschool teacher and director are sure he has ADHD. Well, we had him tested and he does not have any part of it. He has no learning disability what-so-ever. So that brought me back to square one. He is in a positive loving enviroment. How could he be depressed and want to hurt everyone around him? He cannot sit still. He cries and says he is 'stupid" and "can't think" like the other boys. He has nightmares and cannot sleep alone. He is scared of everyone and everything. So, as I sit here crying, I realized that this has all been a reaction of his "medicine" Singulair. He never should have gone through all of those painful tests, only to prove they couldn't find anything. So many treatments and sound full advice speeches from his doctors. How could they be so naive and selfish in the life of my son?

When I called my pediatrician of 5 years, she told me that " parents that have children with behavioral problems will LOOK for something to blame their problems on." She also said "drug companies only put side effects on their labels to PROTECT the drug companies. (as she laughed at me) They are not always valid". Then she said "if you take you child off of Singulair you will be playing Russian Roulette in his life." Then she said that all children around 5 or 6 go though this emotional time in their lives." She told me that if I take my child off of Singulair that she would no longer be a part of his health regimen for his asthma. She told me to see a Pulmonologist for further treatment.
Who is paying who? This is my son's life???????? I decided to go with my mother-gut instinct and get him off of this medicine. No matter what. He has been a different person since. He is currently going though a lot of side effects and withdrawals (leg pain, insomnia, hic-ups, emotional distress) but every day is getting better. How can the drug companies say that this is a "wonder drug?" There are more reported side effected patients then clinical studied patients! How can a "medication" that stimulates the brain not be connected to other problems? This "medication" interferes with the bio synthesis and action of LTs and has been marketed as NOVEL medication against asthma and allergic rhinitis. Who the hell is playing God here??? The pocket books of Merck or our over PAID "doctors?" Who pays the price? Our children? Or us. Thank god I found this before it was too late. I would not be able to withstand the pain of losing my son due to their lack of scientific evidence. They are lucky I am one of the smart ones. I will not settle for less than Justice for the drug companies and their paid "doctors?" You all end up in the same place. HELL

There are 18 million people on this drug. Most of them are children. Please save a life if not your own child's life. Thank You

I have been on Topamax since Jan of 08 for complex partial seizures. I was very pleased with it at first but started having
some more unpleasant symptoms. My hair recently started falling out about two months ago in massive handfuls! I was
and am very upset about it. I did have the tingling in the hands and feet when I first started taking it and I don't drink sodas
at all which I did all the time before. I did not lose weight at first but did a couple of months ago when I got very ill with a GI
problem. I actually lost about 20 lbs in about a month. This is when my hair started falling out. I have had a lot of labs
drawn and my TSH was undetectable but my thyroid levels (T3 and T4 are normal) and my antibodies are normal as well so,
there is no telling what is going on?? I just want off of this medication before I am bald!!

POLL: If you or your child have been adversely affected by Singulair could you please reply to this and let me know what ethnicity you are and skin tone. (fair, med., dark, etc.) I'm interested in the demographics of this drugs effects.
Thank you!

I have been on Wellbutrin XL for 2 years with no ill side effects and it has worked well. 2 1/2 months ago my script changed to the 'generic' BudeprionXL. Since this change, I have been experiencing severe muscle and joint pain, my hands go numb, my skin crawls to the point that I have scratched myself to the point of bleeding. Sleeplessness has just recently started to occur and my teeth have also become very sensitive. General irritability has also set in. I have not yet started to get the headaches most get with the Budeprion and it a good thing as I'm already taking 1600 mg a day of Advil to try and arrest the muscle and joint pain. After reading these other ill effects of this drug I'm now very scared and will be calling my doctor to get her to represcribe Wellbutrin -only- 'no generic'. It is clear to me the FDA did not do the proper research or makes me think TEVA has a friend in the FDA's office.

I have been on singulair for several months or more. In the last month or so I have had a handful of breakdowns emotionally, crying like a little baby some worse than others. I feel paranoid but i don't know if that is just a case of anxiety.Leaving the house has become an issue if it is a bad sad feeling day. I just learned about an investigation tonight and googles it. It lead me here.

I don't know what to do.

My Daughter is almost 11 and has been on Singulair since the age of 3. She has some very serious signs of anxiety. I was never told of any of the possibilities of these kinds of side effects. As a matter of fact the doctor never discussed any side effects. I only know what I read on the prescription information almost 8 years ago. I am horrified to find out about this information. She has also been complaining for a very long time of spasms and pains in her legs which I have brought up to her doctor and he claims they are and have been growing pains. She came home from school the other day and was devastated over some bullying that had occurred toward her that day. I was heartbroken to listen to this from her knowing I cant be at school to protect her from this unnecessary garbage and at the same time was waiting for the 11 o'clock news on the singulair information. Now reading all of this, I am sincerely concerned about what is really going on in her mind after I watched her get up the next morning on her own at 5:30 a.m., ready by 6:00 in a full blown anxiety attack about going to school, and dreading going period. I will be speaking to her doctor immediately and I will be removing her from this prescription to see if there is a difference.