Consumer complaint symptoms and conditions

My 4 year old son started taking singulair when he was two. I don't think I picked up on his behavior change right away b/c I thought that he was just entering the "terrible two's". But over time, his allergist added on Nasonex (I know the docs say that it doesn't cause side-effects b/c it's a nasal spray, but I don't buy that...it's a steroid, plain and simple) and more recently zyrtec was added on for his hives. Well, the zyrtec was the straw that broke the camel's back. I mean, he has been a real "handful" since the singulair, but after zyrtec was added 5 months ago - let's just say he was completely out of my control. His meltdowns were so bad that I couldn't go ANYWHERE with him. I either got a sitter or just didn't go anywhere. He became aggressive, defiant, emotional, unhappy. And to top it off he started to have serious "autistic-like" self-stimulatory behaviors (grinding teeth, squinting eyes shut, flapping his hands, punching himself...). At this point my life had become a complete nightmare, and my poor 10 month old son was getting NO attention b/c my 4 year old was so out of control and aggressive. I was afraid for the baby's safety...oh, I could go on all night. This medication has impacted my marriage, my finances, my sanity. Shortly after he started Singulair I had to go on an antidepressant b/c it too so much out of me just to be his mommy. Anyway, a week ago I had him scheduled for a psych evaluation (thought for sure we were going to walk away with either autism or bipolar diagnosis), but two days before I decided to look up the meds he is on and BINGO! All of these posts sound like what we have been going through. I stopped all of his meds that night, cold-turkey, and he has been the most pleasant little boy I have ever met!! My husband and I have fallen in love with him over the past week - we had no idea he was such a sweet child.

Now, while I'm ecstatic that we have found the answer to our nightmare, I also feel SO STINKIN' ANGRY! We lost out on 2 years with our sweet boy, there were times when we raised our voices at him when he just couldn't help himself - he was suffering inside!! When I went to talk to the allergist about my findings this past week, he said, "well, maybe he just had a good day. I'd like to see what happens if he goes off all his meds for a week". Well, there you have it, he has been off for one week and he's an absolute angel. He has an amazing heart and is so caring!!!

Singulair is awful (and so is zyrtec). Please don't give this drug to your children. Research other alternatives (I am giving my son Nordic Naturals Fish Oil, Culturelle probiotics, vitamin c, and am changing his diet - increased magnesium and decreased dairy. I came up with this after hours of research...).

There is a woman on this site whose daughter committed suicide after 3 years on Singulair. This is no joke and the FDA needs to get with it.

BTW, I used to date a Singulair rep (I knew there was something I didn't like about that guy:)

I have been reading all of these posts and have another question. I hope that someone can help. My daughter, 8 years old, has been on Singulair since she was 4. She is normally a very happy girl with a wonderful disposition. For the last year or so, she has been having trouble getting herself to sleep at night. She says that she hears things in her head such as ringing or "noises". A few hours before she knows it's bedtime, she cries and when we ask her why she's crying, she can't give us a reason. We initially thought that she was crying for no reason because she didn't want to go to sleep. I remember reading about the side effects of Singulair causing mood swings, etc., but her's are not violent mood swings. Just very emotional and has a hard time coming down from the "episode". I'm at a loss...I have not talked to her doctor yet about it, but have told her that we will make an appointment this week to discuss it with him. My husband suggested that maybe it sounded like she was having a panic attack or anxiety attack. I hate to label her as that at such a young age. My mind now goes back to the side effects of Singulair and maybe this is to blame. Any help or suggestions would be greatly appreciated. Thank you! Concerned Mom

Because of a “Global economy” - I suspect ingredients (even for Brand names) are coming from China or being manufactured in India with poor to non-existent quality control standards, and is the primary reason for the majority of Adverse Reactions to the Statins in general. Please take time to submit your complaint directly to the FDA, and hope they investigate and take action (see bottom of page for web sites to submit complaint).

My own recent experience with statins: After 3-weeks of being on generic Simvastatin 80mg for elevated LDL, I experienced significant fatigue, shortness of breath with tightness around my chest and a bout of Gout in my left foot. I would encourage patients/consumers to directly send their complaint to the web sites listed at the very bottom, if you are either a U.S. (FDA Form 3500) or Canadian resident. Also, if your physician is unresponsive to your negative experience with Statins (generic or Brand Name), inform him/her that you refuse to continue with this drug, and that you have sent an adverse reaction complaint to the FDA/Canadian equivalent. Provide both your doctor and pharmacy with a copy of the FDA Form 3500 if you’re a U.S. resident, so they know you're serious. Lastly, I'm back to feeling normal, after I "demanded" my physician switch me to generic Pravastatin 40mg (2 tabs a day - 80mg), manufactured by Teva Pharmaceutical - corporate HQ Israel with manufacturing facility in Pennsylvania. By the way, a 90-day supply of this quality-controlled drug is available at Walmart Pharmacy for $10. I hope this helps, especially seniors on a fixed income.

U.S.A.
http://www.fda.gov/opacom/backgrounders/problem.html

CANADA
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/gui-44_consumer_complaint-plainte_consommateur-eng.pdf
Contact Name: Drug Compliance Verification and Investigation Unit Tel: (613) 952-9906 Fax: (613) 954-0941 E-Mail: DCVIU_UVCEM@hc-sc.gc.ca

I posted the following information belolw under Simvastatin, the generic equivalent of Zocor, which may apply to the brand name as well:

"In follow-up to my posting 3-days ago, regarding an adverse reaction to Simvastatin 80mg, I would encourage patients/consumers to directly send their complaint to the web sites listed at the very bottom, if you are either a U.S. (FDA Form 3500) or Canadian resident. Also, if your physician is unresponsive to your negative experience with generic Simvastatin, inform him/her that you refuse to continue with this drug, and that you have sent an adverse reaction complaint to the FDA/Canadian equivalent. Provide both your doctor and pharmacy with a copy of the FDA Form 3500 if your a U.S. resident, so they know you're serious. Lastly, I'm back to feeling normal, after I "demanded" my physician switch me to generic Pravastatin 40mg (2 tabs a day - 80mg), manufactured by Teva Pharmaceutical - corporate HQ Israel with manufacturing facility in Pennsylvania. By the way, a 90-day supply of this quality controlled drug is available at Walmart Pharmacy for $10. I hope this helps, especially seniors on a fixed income. -

U.S.A.
http://www.fda.gov/opacom/backgrounders/problem.html

CANADA (http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/gui-44_consumer_complaint-plainte_consommateur-eng.pdf). Contact Name: Drug Compliance Verification and Investigation Unit Tel: (613) 952-9906 Fax: (613) 954-0941 E-Mail: DCVIU_UVCEM@hc-sc.gc.ca "

In closing, I would encourage discontinuation of your statin, if it's made by a company based in India or China (call your pharmacist, they can tell you the country of origin).

In follow-up to my posting 3-days ago, regarding an adverse reaction to Simvastatin 80mg, I would encourage patients/consumers to directly send their complaint to the web sites listed at the very bottom, if you are either a U.S. (FDA Form 3500) or Canadian resident.

Also, if your physician is unresponsive to your negative experience with generic Simvastatin, inform him/her that you refuse to continue with this drug, and that you have sent an adverse reaction complaint to the FDA/Canadian equivalent. Provide both your doctor and pharmacy with a copy of the FDA Form 3500 if your a U.S. resident, so they know you're serious.

Lastly, I'm back to feeling normal, after I "demanded" my physician switch me to generic Pravastatin 40mg (2 tabs a day - 80mg), manufactured by Teva Pharmaceutical - corporate HQ Israel with manufacturing facility in Pennsylvania. By the way, a 90-day supply of this quality controlled drug is available at Walmart Pharmacy for $10.

I hope this helps, especially seniors on a fixed income.
-------------------------------------------------------------------------------------
U.S.A.
http://www.fda.gov/opacom/backgrounders/problem.html

CANADA
(http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/gui-44_consumer_complaint-plainte_consommateur-eng.pdf).

Contact Name: Drug Compliance Verification and Investigation Unit
Tel: (613) 952-9906
Fax: (613) 954-0941
E-Mail: DCVIU_UVCEM@hc-sc.gc.ca

i was a healthy 35 year old male but had high cholesterol, so the doctor prescribed lovastatin (mevacor) and tried it for a month but developed muscle weakness. months later, i'm still experiencing severe muscle spasms and my neurologist is stumped -- mri's, spinal tap, emg -- all normal. I just want to feel normal again. can anyone help? please email me!

just another update on my other 2 postings. Things have really hotted up here, lets just say the doctors surgery will get a nasty surprise in the post!! I urge anyone who has been conned into taking this drug to make a stand, sooner or later the medical community is going to have to listen. Websites like this are a godsend, but....POWER TO THE PEOPLE!!!! Give them what for, they can't brush this under the carpet for much longer and they have no right to make anyone take this drug. My doctor behaved as if nothing had happened, I nearly pegged it and they treated me like a nutcase! The most annoying thing is that I already have Crohn's Disease so I should never have been put on it, but they completely disregarded that fact, something they have been aware of for many years...NO EXCUSE at all. There is a definate cover up, have you seen the news this week??? More people are to be started on simvastatin because the government wants to save money on heart operations!!! They are either incredibly stupid (no surprises there), or have been completety sucked into the statin hype. There is going to be a massive strain on the NHS because of all the other health problems this drug causes, I saw 3 different specialists because of my sudden ill health, do they really think it will save them money??? Any one from the Government reading this?? get your bloody finger out and do something! Apart from not saving money, what cost to all that have been put on it??? what about their health? and by the way, I am the patient but I HAD to ask the doctor for a test for muscle wastage even though he knew this had been occurring, non admition of guilt then? National Health? NO National Joke and we are on the recieving end. I am not a lab monkey and don't want to be a test subject for these poxy drug companies and neither should anyone else, get RID of these awful drugs!