Mhra symptoms and conditions

Has anyone experienced vision problems ? Seeing red and green dots ?

Does anyone know if Singulair can cause heart valve problems? I just found out that I have Mitral Valve Prolapse, and have never had any problems until after taking Singulair. Any info would be greatly appreciated...especially from Concerned Citizen if he's out there...

Thanks,

K.

May 16 y.o. daughter has chronic sinus infections and sever headaches. They said it was allergies and put her in Allegra D and Singulair. Headaches seemed better with slightly fewer sinus infections. Once I heard about the mood swings and Singulair I took her off. Then the Allegra did not seem to be able to keep up with keeping the sinus infections at bay. We finally figured out that she has a deviated septum and will need surgery. Anyway, we put her back on Singulair so we can get though the season with as few sinus infection until we can schedule surgery around high school and sports. Then we were noticing how her hair has become so thin. She used to have really thick hair and now her pony tail is to thin and small. After doing internet searching, we found out that other people are having this problem with Singulair. I took her off of it 4 days ago and already the shower has less hair in it. You can't tell a teenager that she needs to stay on a medication and lose a ton of hair. I am hoping that her hair will grow back quickly.

I am a 57 year old man, who has been suffering from asthma several years. This spring my doctor put me on Singulair as an additional medicine to my cortisone-inhalator. after one month I feel symptoms of depression an mood-changing, severe ups and downs.
AND - as an additional symptom i have partially lost my feeling in some fingertips, and now parts of my left thumb and even a feeling of "cold2, mostly in my left hand.
anyone who share that symptom?
M.

From a UK Yellow Card Report.

Montelukast

The product information for montelukast has been amended to include the following ADRs: Reaction No. of UK Yellow Card reports

Nausea 63 Diarrhoea 54 Rashes 52 Insomnia 44 Dizziness 42 Fatigue 37 Vomiting 24 Pruritus 24 Arthralgia 20 Urticaria 19 Malaise 18 Dyspepsia 13 Myalgia 12 Dry mouth 9 Anaphylaxis 4 Angioedema3

In addition, the following suspected ADRs have been reported and are still being evaluated: psychiatric disorders (63) ; also nightmares (13), sedation (13), palpitations (12), tremor (10) and increased sweating (10).
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Zafirlukast The most frequently reported ADRs under the Yellow Card Scheme for zafirlukast have been rashes (7), headache (7), abdominal pain (6), nausea (6) and pruritus (5). All of these are included in the product information which has also been updated to include the following ADRs that have been identified from data other than UK Yellow Card reports: urticaria, angioedema, blistering, bruising, bleeding disorders, including menorrhagia (rare), thrombocytopenia and agranulocytosis (both very rare). Churg-Strauss syndrome Churg-Strauss syndrome (CSS) is a rare syndrome characterised by a history of asthma, and often rhinitis and sinusitis, with systemic vasculitis and eosinophilia. There has been a recent increase in the number of reports of CSS associated with the use of anti-asthma drugs, particularly the leukotriene receptor antagonists. The MHRA/CSM have received 63 reports of CSS through the Yellow Card Scheme since 1963, 59 since the beginning of 1998; Of these, 90% were associated with drugs used to treat asthma (mainly leukotriene receptor antagonists). In many, but not all cases there was documented evidence of a reduction or withdrawal of oral corticosteroid therapy prior to the onset of the reaction. There are clear warnings regarding the possible association with CSS in the product information for montelukast and zafirlukast. Prescribers should be aware of the possibility that, although rare, CSS may be the underlying cause of asthma in their patients. In patients prescribed a leukotriene receptor antagonist prescribers should be alert to the development of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or peripheral neuropathy. The identification of new and suspected ADRs emphasises the important role of the Yellow Card Scheme in helping to ensure the safe use of medicines. The safety profile of leukotriene receptor antagonists remains under close review. Please continue to report all suspected ADRs to montelukast (Singulairt) and zafirlukast (Accolatet) through the Yellow Card Scheme.1. MHRA/CSM Current Problems in Pharmacovigilance 1998; 24:14.
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http://64.233.169.104/search?q=cache:3fU602hhlG8J:www.mhra.gov.uk/home/groups/pl-p/documents/publication/con2023236.pdf+montelukast+ADR&hl=en&ct=clnk&cd=10&gl=us

HOW TO REPORT YOUR SIDE EFFECTS (UK ONLY)

Since having awful problems with my Mirena, I have been staggered that the wealth of reports from women on the internet and yet the corresponding lack of knowledge by doctors. This is because the information provided to doctors is wholly inadequate and does not inform doctors that severe and debilitating side effects can occur in the long term. In order to do something about this, we all have to report our side effects to the MHRA (the body responsible for drug licenses and labeling in the UK). You can do this on-line at www.yellowcard.gov.uk or you can phone them on freephone 0808 100 3352.

Nothing will be done unless we ALL report what we have suffered.

I had the Mirena inserted in October 07 because of very heavy menstruation problems. I have never tolerated the pill so I was nervous about the possible hormonal side effects of the Mirena, My GP and Gyno both played the side effects down and maintained that the dose of hormones was so small and only released "locally", whatever that means. The first month was ok, I spotted daily and did not experience any other serious side effects, just the occasional cramping. The first day of my Mirena period I had a massive vertigo attack, spinning out of control for a couple of hours. I was due to catch a plane that day and had to cancel my weekend away with my husband. My GP maintained it had nothing to do with the Mirena and that I had an inner ear infection. From that day on I experienced chronic dizziness, and increasing symptoms of heart palpitations, nausea and anxiety. By the end of the second month, I felt I was loosing my mind, becoming extremely irritable and very anxious for no apparent reason. My body felt like it was in a constant state of alert. I decided to have the Mirena removed and experienced almost instant relief form the dizziness and chronic anxiety. I "crashed" 9 days later for about 4 days when all my symptoms came back with a vengeance and it felt pretty scary. 6 weeks post Mirena I feel chronically fatigued and have achy and weak legs. I have consulted a naturopath who has given me a cocktail of vitamins, minerals and instructed me to be alcohol free, caffeine free, wheat free and cow's milk free. I try to walk my dog once a day and eat extremely healthy food and sleep. I have had to stop work for a month.The Mirena experience has been a disaster for me and I am still waiting to get back to my normal self. Reading this site does give me support in knowing that others have experienced similar debilitating symptoms. I have felt very let down by the lack of medical support and understanding of what Mirena can do to you.

hi ladies,
further to guest 35696 's point about reporting side effects to the fda etc here is the website for the uk's equivelent. www.mhra.gov.uk click on the "yellow card" tab this will send a report about the side effects of medicine. if you also want to look up reported side effects then go to the download side effects page but remember when you do the alphabetical search that yasmin will be listed under it's chemical ingredient (D for drospirenone not under Y for Yasmin.) it makes for quite interesting reading.
It really is very important that we report the bad effects as if no one reports it, it will never be taken off the market or even prescribed with more caution than it is now,it is our responsibility to try to protect other young ladies from this hell that we have all suffered.

silke,maybe i have mis-read the previous post, i find it so hard to figure out meaning when reading a post or text messages,a perfectly harmless comment can sound rude in a message, as i said i did not mean my posting to sound rude,i agree that we should have a "chat room" for all the ladies who want and need contact with other sufferers,this site is getting pretty heavy going now for newcomers that are just looking to see if their specific symptom is here.there are a lot of pages to get through!!!!! if i knew how to start up a chat room i would do it myself but i am a total idiot at anything to do with computers!
hope your gig went well the other night,i love the abba song you were going to sing.

remember ladies please report your side effects.

sarah

just wanted to post the address again for uk residents to report side effects and adverse reactions of yasmin. it is www.mhra.gov.uk about half way down on the right hand side of the home page is a bit that says yellow card report side effect.click that. if you want to look up previous reports look on the download side effect link and select drosperinone (the main ingredient of yasmin) it makes for interesting reading to say the least! please please ladies if you haven't already done this do it as soon as you can,it takes minutes and could spare another lady the nightmare we have all been through. with more and more doctors prescribing this pill we have to try and speak out. i came across a site that is suggesting yasmin as a treatment for pms....how many women are going to believe the hype and end up on here distressed and ill ???????? we may not be able to stop this drug being prescribed but the more people we can warn about the possible effects the better.

sarah

hi all,
for all you ladies in the uk that want to report your side effects please fill out the yellow card section on the following website. i am so angry about the problems i have had since being put on yasmin that i really really wanted to do something. i know many ladies on here have listed sites for reporting the side effects but they seem only to apply in the USA. this is the uk equivelent. www.mhra.gov.uk click the yellow card tab on the right hand side or click on the online services tab on the top and follow the links there. please please please ladies do this,maybe if enough of us report the awful things we have suffered someone will listen instead of just fobbing us of with a dodgy diagnosis! it may also stop other women having to live the nightmare we have had to.it only takes a few minutes and could potentially prevent this happening to other women or at least make our gp's aware of the possible mental,psychological and physical side effects instead of just sending us off with a prescription for anti depressants.

hope you are all hanging in there...... sophie,silke,murph70..how are you all doing?

sarah