Investigations symptoms and conditions

I am 27 had my Mirena inserted May 05 as I could no longer take the pill and I was diagnosed with endometriosis. It's known as a preventative for the spreading of endometriosis due to the lack of menstrual bleeding. I've not had menstrual bleeding since August 05 and not suffered from any side effects. I thought it was the best contraceptive ever invented, so happy with it.To think no periods, cramps, remembering to take the pill and not to forget how much money I've saved over the past years by not having to buy contraception or female toiletries. How ever I've had four UTI's since the Mirena was inserted. I never suffered from UTI's before the mirena was inserted. I have not changed my hygiene practises, fluid intake and I'm having less intercourse. So is it caused by the mirena??? I can't be sure but I'm am very suspicious. Think I'll consult my Gynecologist

I have been making inquires as to how and if the fda will conduct investigations in to permanent damage left from this drug.Although on taking my son off this drug i saw a 90% improvement,i am still missing the final piece,is it that he lost 3 years to this drug or did it do damage that cannot be fixed,we as parents need to know.The FDA responded to my letter,they said if they see a trend in reports from medwatch,it may prompt an investigation .I am asking all who still have missing pieces to file a report.What has happened is a tragedy,we need to explore ever option for continued success for our childrens future.Good Luck to all,Keep Fighting

I have had the mirena 13 months. After reading all these postings I have decided Im calling the doctor tomorrow and having this ridiculous thing removed. I have ALL of the symptoms everyone has wrote about: headaches, horrible back pain, weight gain of 15 pounds, decrease sex drive, severely depressed, terrible mood swings, constantly tired, hot all the time - sweating, unexplained joint problems, heavier periods now then before mirena, and nausea, sick feeling every night. Thanks for confirming that Im not going crazy and that I can be me again!

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 just viewed a commercial for Singulair now marketing directly to children. Has anyone seen it? They're promoting cherry flavored chewables and a cute little kitten in the background. The side effects so many of us have experienced with our children are still not mentioned instead they've done the exact opposite. With this drug under investigation(Dr. Sarah Sellers has already sent a personal email from the FDA) this is immoral! What can we do to stop any more children from being injured? Merck has no ethics, NONE!

I discovered this site last Wednesday morning - without taking the time to list all of the grief I felt reading through the pediatric postings, I will briefly note my 4 year old daughter has been on Singulair for 2 years now. What I now realize is all the behavior issues, night screaming, etc. are so easily dismissed as stages of a toddler. She has suffered (as well as our family) every symptom and behavior listed by parents on this site with the exception of leg cramps.

Our entire family can see the dramatic results since taking her last pill last Tuesday night. The melt downs and tantrums are all but over, she even commented "hey, I listened right away" on the second day without Singulair. She is still having night terrors - I call them that because they are in no way a dream or nightmare, but rather agonizing moments that break our hearts to hear. I hope those will soon go away as well so her sleep pattern results in a restful night.

Am I angry that we have all suffered for 2 years only to find we have been basically poisoning her? Am I angry that for the 2 years her dad and I have sunk pretty low, feeling inadequate as a parent to teach and discipline our child? Am I angry that after 20 years of marriage, raising a great 16 year old in the midst of all this, we were to the point of the ADD, bipolar, etc. theory that would have been misdiagnosed? Heck no, we are all so thankful to have come across this site and are so giddy and excited to be happy again.

What I am angry about is this - when I called our pediatrician last Wednesday and relayed what I had seen on the Merck website for side effects added in recent months she had not heard this information and asked where I saw it. At that point I had not seen this site. I asked her how is it the well dressed pharmaceutical reps come in with doughnuts, exotic trips, etc. to market a drug with "ABC" treatments and "XYZ" side effects, continue to market the drug and never update the doctors when original selling points are altered - ie; new side effects.

The FDA website is troubling for two reasons: Merck is in charge of their own investigation regarding recent complaints and the FDA expects this to take 9 months. Gee, who gets to investigate themself? Secondly, in February the site notes the FDA and Merck are trying to find the best way to communicate the concerns being investigated to prescribes and patients. HELLO - we live in a world of real time, instant communication methods, two examples being the United States Postal Service and an internet connection.

Today is April 30 - a full two months after "trying to decide how to pass this information on" and my doctor, nor my pharmacist have received any information. Apparantly since we missed the story and coverage on Dateline we are out of luck.

I plan to start from ground zero to get our voices heard to change the way, or the law if you will, to implement an immediate communication link between the FDA and prescribes when an investigation such as this has been initiated. I realize Singulair has most likely benefited more humans than it has destroyed while on the drug and the FDA would have to clearly not communicate "panic". However, when a drug is used for pediatric treatments we need information quickly to assess on behalf of our children. In my case, since my daughter had been on the drug since 2 years old, I do not know what her "normal behavior" should be as that is the age they start to develop and show personality. Additionally, when enclosed prescribing information is updated with a prescription -MARK IT IN RED, "UPDATED INFORMATION". I read every ounce of information that accompanies a new prescription for any family member. I would NOT, however read the information every 30 days for an ongoing, long term prescription over the course of 2 years.

I am looking for anyone that may have started contact with a congressional representative or otherwise to change the communication to our doctors. Please note - I am in no way interested in any legal action regarding Singulair and our nightmare. We are moving forward and do not wish to live the nightmare one moment more. I simply want to see our doctors and pharmacists have vital information as it happens.

Thank you to all for sharing your experiences - I truly believe it is changing lives and making a difference. I am personally telling everyone I know about what is happening with our child and all of yours. Andy by the way, by telling one of my long time friends our amazing discovery, she realized she had been suffering from depression for some time and chalked it up to various things going on in her life. She had her last Singulair last week and feels tremendous! So keep the word going!

So after reading enough of these replies I've come to a few conclusions:

1) Apparently Singulair should not be prescribed to children.

2) We have some extremely over-reactive parents.

3) It sounds like many of you describing side-effects from your young children also mention that they are on other medication(s). Don't be so quick to blame Singulair for everything. Many medications share the same possible side effects. Unless Singulair is the only medication your child takes, hold your tongue until more definitive studies and investigations are done.

About me -- I'm a 30 year old man who developed asthma when I was 11, and has fairly nasty seasonal allergies (I live in Austin, TX). I started taking Singulair several years ago as I had literally tried every other prescription allergy medicine on the market available for my seasonal allergies. OH MY GOD! I CAN BREATHE AGAIN!

Not only could I breathe through my nose, but the Singulair helped me fight off seasonal allergens (namely mountain cedar tree pollen and Texas oak tree pollen) so much that I was no longer waking up having asthma attacks from my sinuses draining. No longer was I missing days and days of work from "cedar fever" and "oak fever." At long last I finally found an allergy/asthma medicine that works for me.

Now, I also take use Advair (250/50) every day as well. Without a doubt, my life is 100 fold better now than it was before I used the combination of Singulair and Advair on a daily basis. If I miss a day or two of my Singulair, which I have done before, my allergies are noticeably worse and magically get better when I get back on Singulair.

I can honestly say that I have never experienced any depression or suicidal thoughts/tendencies since I have been on Singulair. Undoubtedly there are many others like myself who thank God every day for this medicine. I honestly feel very bad for those of you who have issues with Singulair because it has been a life-saver for me.

My sister is 48 and now hospitalized for suicide watch. She takes Sinulair or took and now they are looking into the relationship of the two. I am happy it was caught before it was too late.
This drug needs investigations.. real investigations before we lose our loved ones...

MY WIFE HAS BEEN TAKING ZOCOR FOR ALMOST 4 YEARS, SHE NOW SUFFERS FROM BACK PAIN ,JOINT PAIN ,MUSCLE PAIN,GENERAL STIFFNESS ,BACK MUSCLE TWITCHING,STOMACH PAINS AND FATIGUE. IN THE LAST YEAR ITS GOT SO BAD THAT IT HAS COMPLETELY CHANGED HER LIFESTYLE(MINE TOO...I NOW KNOW WHERE THE HOOVER IS KEPT!!!!!!!)
DEXA SCAN MRI SCAN NEUROLOGIST ORTHOPEDEIC SURGEON
NONE COULD FIND ANYTHING WRONG!! WHILE ALL THESE INVESTIGATIONS HAVE BEEN CARRIED OUT HER G.P. CONTINUES TO PRESCRIBE ZOCOR!!! THANK YOU FOR YOUR INFORMATION FROM THIS MOMENT SHE WILL NEVER TAKE ANOTHER ONE