Adverse events symptoms and conditions

I just wanted to be sure you all read the directions in the pamphlet that they give you when you get the IUD....here they are in case you forgot to read the fine print.

ADVERSE REACTIONS
The most serious adverse reactions associated with the use of
MIRENA are discussed above in the Warnings section. Others are
presented in the Precautions section. Other adverse events reported
by 5% or more subjects include:
Abdominal pain Upper respiratory infection
Leukorrhea Nausea
Headache Nervousness
Vaginitis Dysmenorrhea
Back pain Weight increase
Breast pain Skin disorder
Acne Decreased libido
Depression Abnormal Pap smear
Hypertension Sinusitis
Other reported adverse reactions occurring in less than 3% of
patients include: failed insertion, migraine, vomiting, anemia,
cervicitis, dyspareunia, hair loss, eczema.

My 3 years old daughter was on Singulair for 8 months, that was prescribed by her Pedestrian from the Asthma clinic in Canada, Quebec. Lately, some of the symptoms of adverse effects are surfacing in her, including depression, action very emotional, constant having bad dreams (which causes tiredness), crying almost whole day in the daycare, refusing to eat and drink, refusing to join her favorite activities... Her Pedestrian told us there is no side effect on Singulair when she renewed the prescription 2 days ago. Because of my doubt about that, I started research on the web and found out that the early communication was issued by FDA. Of course, I took my daughter off from Singulair right away.

I work in the drug development clinical research field. I know that nothing the FDA or Health Canada will pursue until a lot of cases on adverse events (side effects) reported to them. Please everyone, if you or your child has had developed any side effects on this particular drug (Singulair), please report to FDA at once. It got me so upset is that this drug is constantly and widerly prescribed to children, and the Pedestrians are not caution enough to tell the parents. I definitely do not want to see other children suffer the same symptoms as my daughter had.

Hello everyone. I have had my mirena in for 2 years now and have absolutely no desire for sex at all. I decided to google the Mirena side effects to see what I could find and this site came up. Let me tell you all your story sound just like mine, but the one symptom that I haven't seen is having symptoms similar to Lactose intolerance or Gluten intolerance. I did find this ****** website and it specifically states "Glucose Tolerance
Levonorgestrel may affect glucose tolerance, and the blood glucose concentration should be monitored in diabetic users of Mirena ." Now I am not a diabetic, but my family Dr. said that I had all the symptoms of being Glucose intolerant. I was tested and came out negative. Also all my symptoms increase the longer I go with out a period. I usually go 2 months without, as soon as I have it it is like my body come back to normal for a week.
Now my husband is all about permanent solutions, so I told him that I was ready for a more permanent birth control. snip snip. I am planning on having mine taken out this year. I just want my body back.

Oh this website that I have attached is the actual Official FDA information sheet that we don't get to see, but the doctor does. Make sure you read the adverse reactions. Here they are so if you don't get to the website.

Adverse Reactions
The most serious adverse reactions associated with the use of Mirena are discussed above in the Warnings section. Others are presented in the Precautions section. Other adverse events reported by 5% or more subjects include:

Abdominal pain Upper respiratory infection
Leukorrhea Nausea
Headache Nervousness
Vaginitis Dysmenorrhea
Back pain Weight increase
Breast pain Skin disorder
Acne Decreased libido
Depression Abnormal Pap smear
Hypertension Sinusitis

Other reported adverse reactions occurring in less than 3% of patients include: failed insertion, migraine, vomiting, anemia, cervicitis, dyspareunia, hair loss, eczema.

******

I am also experience hair thinning while on Wellbutrin. I have had blood tests and there is no other detectable cause. The dermatologist said that she was only able to diagnose as possibly hereditary. However, I began noticing it shortly after starting 300mg of Well XL and then noticed increased thinning when I went up to 450mg. I don't take any other medications at all.

I searched the Wellbutrin prescribing information (a pdf on the official Wellbutrin website) and this is all I can find:

Other Events Observed During the Clinical Development and Postmarketing Experience of Buproprion

Adverse events for which frequencies are not provided occurred in clincial trials or postmarketing experience with bupropion. Only those adverse events not previously listed for sustained-release bupropion are included. The extent to which these events may be associated with Wellbutrin XL is unknown.

Skin: Rare was maculopauplar rash. Also observed were alopecia, angioedeme, exfoliative dermatitis and hirsutism.

----------------

Alopecia is hair loss. All that means is it was reported and they didn't do a study that would have produced data with which they could measure the likelihood that it is a Wellbutrin side effect. In other words, people said they were experiencing it but they can't confirm it.

I just dropped down to 300 mg and I'm contacting my shrink about tapering off completely - I feel like dealing with scalp showing through and feeling horribly self-conscious and unattractive because of it is not going to help my depression and self-esteem issues any.

I'm a woman by the way - the number of reports of hair thinning in women seems significant to me. I have no family history of thin hair on the female side that I know of.

My nephew is 7 and has been on Singulair for probably 4 years. His symptoms developed over time but recently have exploded. He has epilepsy so most of the things that he has experienced has been blamed on that. However, today his doctor took him off singulair and said he believes his symptoms are caused from the drug. He started having head drop seizures, fell out of his desk and cut his face one day. He has also been depressed, had severe anxiety attacks for the past 8 months. Several months ago, he started having such severe nightmares that it is almost impossible to get him to go to bed and go to sleep. Recently he began "seeing dead people" and "monsters" that we trying to kill him even when he was awake. He has also cried many nights with leg cramps and severe stomach pain. I will update this page in two - three weeks to let you know if these problems go away now that we have stopped the singulair.

Unfortunately my lawyer told me that they do not want to take our case because of the lack of evidence that Singulair has caused our daughters problems. :(

Does anyone out there have a pending class action lawsuit that We may be able to get in on? I have tons of proof that Singulair has caused our daughters problems and loss of almost 5 years of her elementary school career!

My phone number is *** and my email is ****** if You email me please put "Singulair" in Your subject line so I know it pertains to this posting.

Thank You in advance,
Chuck & Brenda
Jamestown New York

Here's a way out theory about my unique and to me mystifying medical situation....

I recently read where Singulair, an asthma medicine, is suspected of causing suicides, obviously an effect on the brain function. The FDA notes that over the past year, Merck has updated Singulair's prescribing information and patient information to include the following post marketing adverse events: TREMOR (March 2007), (April 2007), suicidally (October 2007), and anxiousness (February 2008). (the tremor highlight is mine since this is a major symptom of Parkinson's )

Well, I took Singulair from 1998 to 2004 and I wonder if maybe, just maybe Singulair could be a contributing factor to my strange Parkinson's but not Parkinson's problems that is
gait,
balance,
freezing of gait problems

Any thoughts or ideas on how I might follow up on my hypothesis?

I am posting an update on my granddaughterwho has been off for 2 weeks since the story broke in the news. There certainly has been a difference, she's more 'present' when I'm speaking with her, not angry, calmer and she slept through the night the other day when she came over to visit. There were actually no 'scenes' or carrying on. However, in light of the last posting I do not know how she will be affected in the long term, None of us can know that, none of us know how this drug actually works on the brain to create such side effects. I just saw a Singulair commercial on TV and almost got sick. Cody Miller's mom in her post stated that he had no behavioral problems before his death. I imagine that is true for the majority of us. My granddaughter never had the need to go see a counselor before this drug. She was a happy, normal 9-year old. That all changed in only 2 months as her mother took her to a psychologist to find out why she was acting so bizarrely. I am convinced this drug has caused untold misery and should be at least restricted to adults or at most taken off the market. This website is only the beginning at some point those who feel strongly will have to come together and organize against this giant company Merck.

I am starting a new post in the hopes that others will see what I am trying to say about the delayed reaction in those that took Singulair for allergies.

If it is consistent that Singulair does not stop allergy symptoms immediately, then the pathways that eventually stop allergy symptoms involve a change in the mast cell function, development and migration (or some combination).

I asked this question for a reason. Are allergy symptoms stopped immediatedly. My question below:

I have a question that will help me continuing looking for information. I can understand that in the case of asthma that Singulair would provide immediate relief. If it is used for seasonal allergies or other allergies without asthma, does it work right away or does it take a period of days or weeks to be effective? If it takes time, could you tell me how long it took in your situation?

My thinking was going in the right direction if the answer below is consistent of everyone or most.

about 2 hours ago on Apr 11, 2008 by catherineevans, #7045
My granddaughter was put on Singulair for allergy symptoms without asthma. Itching, red eyes, terrible congestion, etc. dark circles under her eyes all the time. When we first put her on this, we didn't see any consistent results for 2-3 weeks, then it seemed to 'kick in.' I don't know if this helps. By the way, she was 9, now she's almost 12 and was immediately taken off when this story came out 2 weeks ago.

Then after seeing one response, I gave my reason for asking.

I asked this question because I have a theory of how montelukast really works for allergies as compared to how it works for asthma.

Asthma is a hyper-sensitive state that gets going because the mast cell has a receptor (the leukotriene receptor that Singulair blocks) that sends a signal along a pathway that causes lung tissue to have that extreme response - the wheezing, the airway constriction.

On the mast cell is another receptor the histamine receptor that causes the secretions that make our noses runs and and stuff up. This is not the same immune response as the asthma response. When I saw a post that somebody's doctor said that Singulair is an anti-histamine, NO it is NOT.

So if Singulair does not block histamine immediately and your child's allergies did not go away immediately, then maybe Singulair is working through some other means such as changing normal mast cell homeostasis.
I know that this seems like "what does this mean?" I am really writing this hoping to God that there are people reading this site that know what I am talking about.

Thank you so much for responding. Your answer actually told me what I wanted to know and confirmed my hypothesis. More answers will help. I hope others respond.

PLEASE respond about the length of time that allergies disappeared if you took Singulair for allergies.

I just visited Merck's Singulair website and spent a long time really, really thinking about everything that they had for physicians. After thinking about the pathways for myself from the standpoint of chemical interactions, I wanted to know what was explained to the physician. I approached the site from the standpoint of -- if one of my patients was overdosing, how could I recognize that. What would happen? Merck's site has diagrams and movies on the nasal passages and the lungs. You get a picture of a mast cell producing-- doing it's thing. That was it. And on every page, this...

SINGULAIR is indicated for relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and children aged 2 years and older and perennial allergic rhinitis in adults and children aged 6 months and older).

In clinical trials, SINGULAIR was generally well tolerated, with a safety profile similar to that of placebo. Adverse events varied by age. The most commonly reported adverse events, occurring at a frequency of ≥1% and at an incidence greater than placebo, regardless of causality assessment, were sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis, and increased ALT.

SINGULAIR is contraindicated in patients with hypersensitivity to any component of this product.

Okay, let's talk about headache at greater than 1%. Headache is 18-19%. How do I know that from what they put on their website?

It might be a very good question to ask your doctor if they could go to the Singulair website and be able to know what would happen if they had a group of children or adults that liked to take pills. Yum, one of good, more is better. I had no clue from that website if there was a risk of overdose or not.

This is not my area. I am trying to help. I am essentially as in the dark as you are.

To Matthew:
just to let you know that mlkeene may be right about what she mentions about Singulair, however everyone has a different biochemistry and you must respect that. One man's meat is another's poison. You go down hard on a company if only you can justify how badly a drug has proven side effects, Have anyone of these patients on Singulair thought that these abnormalities were due to a drug, a specific one, Do you also know if they were on poly medication?/ These are questions to ask, before trying to run a national racket!!! These patients have not once mentioned that they reported these adverse events to the company's drug and safety department. Think about it.

when my son (now five) first started treatment for allergies at almost 3, he went on zyrtec and singulair. he was moody, grumy, and needy. i just assumed he was 3. after about 10 months the allergist switched him to pcm chewables with his singulair and he turned evil. for example, he wasn't quite 4 and attacked me one night because he didn't want a bath. it took several minutes to pry his hands of of my neck. it scared me to death. since he was already on singulair i assumed it was the pcm and finally found a pharmacist who said that it "might" can have those side effects. the allergist wouldn't accept that it could do that and wouldn't change his prescription. finally went to new allergist who changed him back to zyrtec but wanted to stay on singulair due to new asthma diagnosis. his behavior got better, but still very moody - many ppl said "spoil" because of huge meltdowns over nothing. he is now 5 and has been on allergy shots for a year. about 6 months ago the doctor said could take him off zyrtec but keep on singulair. i thought yay! mood will get better. it didn't. he was still getting notes from kindergarten teacher for talking too much, fighting, moodiness, meltdowns, etc. we took him off singulair to see how asthma would do since allergies doing better. he started getting greenlights! we still have some meltdowns and moodiness. but, it is slowly getting better. i wonder how long it takes to clear out of their system?
in the last six months we have periodilly put him back on zyrtec and singulair when allergies acting up. his teacher tends to send home notes that week asking if he is on medicine. it never occurred to me that it could be the singulair! what scares me is that 3 weeks ago he said he wanted to get a knife and cut his head off so he could "go to Jesus". i talked to him and finally decided he was just talking, don't think he truly meant it. but now, i look back and realize he was on singulair at the time!
the scary thing is that my one-year old is also on it for asthma. i got put on it recently for chronic sinus problems and my husband has been on it for years! i think I will not be giving it to any one until we talk to the doctor!

as a side note i have a friend with a 22 mo old that drs have tried to put on singulair off and on since she was 12 mo or so. every time it makes her unable to sleep. mother agreed to try it again recently because child's asthma was so bad and they ended up at the ER because the baby couldn't quit crying!

I'm one of the "no effect" people...

I've been on Singulair for over 10 years as an adult and have had none of the side effects. For me, it's changed my life. I went from 4 different inhalers (13 doses a day) to rarely using my albuterol inhaler (maybe once a year).

I was having Kenalog injections into my knee. On the ninth injection within a years time,with a few Aristospan injections in between, my knee to my foot blew up. Tripled in size, and the skin was bright red with purple marks all over the skin from my upper shin to the ankle bone. I had a big depression in the shin too, which I can not figure out because the injection was into my knee.
I went to my GP who sent me to the ER to rule out a blood clot-ultrasound.
NO blood clot. I was given no medication, nothing, and it was very painful.
Actually, I saw three doctors and not one of them seemed to care. One doctor said, "Steroids are Powerful Drugs" I do not know if this reaction was do to an infection, some side effect, I have no idea. The swelling eventually went down within six months=long time. I still get purple round marks on the skin at the shin, and sometimes my ankle swells. The skin gets red and white marks mixed into the already rash looking skin.
I asked many times what the cause was to this all, and it was like no doctor would say anything negative about the doctor that gave me the injection.
I also discovered that Kenalog is used off label for Epidural Steroid Injections and can cause Meningitis, Arachnoiditis, bowel and bladder dysfunction and more adverse events, because neurotoxins are added to the steroid to make the compound that is injected into the epidural space. Asking other people if their doctor ever told them the drug name they were getting injected by their doctor before this procedure and each and all said "NO."
This is also true for the drugs Depomedrol and Celestone Soluspan. All three drugs are used off label for epidural injections. Neurotoxins do not belong in the spine! If one gets a dura puncture-FOR GET IT!

Post your side effects at www.fda.gov/medwatch, on the Food and Drug Administration's (FDA) MedWatch site, which is under FDA's Center for Drug Evaluation and Research (CDER). According to someone from that office, CDER is supposed to report adverse events to their Drug Safety Oversight Board, and then the Board is supposed to decide if the drug should be pulled. FDA can claim they do not know about the claims if no one calls them. See staff below:

Steven Galson
Deputy Director
(301) 594-5400

Randy Levin
(301) 824-7784

Safety Policy and Communication Staff can be reached at (301) 594-0104. Staff include:

Paul Seligman
Norman Marks of MedWatch
Susan Cummins of Drug Safety Oversight Board

I took Levacquin in APril & thought it was my imagination that my hip began aching. I now have severe tendonitis & cannot drive. I am thin, an athlete & never had such a prblem. Then my kness swelled up, my neck spasms constantly & I looked this up here.

My dr. told me not to work out when taking this & I did not BUT this still happened. A small case of tendonitis is what she said might happen! Not swelled knees, bruising, fatigue like I am 90 years old. As for the idiots saying this is "whining"? I work 70 hours a week as a project manager in the FDA field. I have no time or desire to whine. Perhaps 100 plus entries does not hit you as odd but it actually is, for we educated people. DId I mention that I work in an FDA related field? I just had a sinus infection that would not clear up & I did not bargain for this ...nor was I told. I am going to go to the fda.gov website & ask for their "adverse events" reporting information (based on the drugs clinical trials) which they have to release by law. I advise that you all do as well ..... uh, except for those that have too much tome on thier hands and just don't get it.

Hycotuss is not as addictive as Tussionex because it is not a suspension. It still has hydrocodone in it so it can have a seditave effect like Vicodin ES. Although for some people hydrocodone can have an adverse events such as racing thoughts and nervousness, which is contradicted in an opiod. This applies to Xanax, too, in that it should not be given to children or psychotic patients because it may stimulate unprovoked rage and activity from them. These are called paradoxial reactions and so far the ones in the benzos seem to apply to the opiod family too. Good Luck, Mr. Pharmaceutical