Adverse event reporting system symptoms and conditions

Hi, my name is M. I just got up with my son Jo Jo as usual about 2:00 pm. Nightmares--severe. Leg and foot pain. In fact I thought he was having restless leg syndrome and the doctors had him tested for seizures. His moods are horrible. Tantrums have been out of this world. After two years of sleep deprivation for both of us, something said look at side effects of Singulair. Actually, I believe that something was God because as I massaged my son's legs I prayed. I came to the computer, found his website and saw my son's symptoms written out clear as day. We are done with Singulair. Forever. I just walked back to the room and apologized to my sleeping son. I can not tell how horrible I feel as a parent for my child to have suffered so. I also can not begin to describe the relief I feel right now. My son has enough problems without medication causing him to suffer. I have suffered as well. As a single parent I have to work but I am often sleepwalking through my days. Thank God for all of you who posted. You have saved my son's health and quality of life. And mine. Thank God!

I was prescribed Singulair on a Tuesday & started taking it that evening & that night I began to have horrific dreams. My dreams are usually very vivid & crazy but once I started taking the Singulair they turned really dark & scary. I would wake up freaked out & didn't want to go back to bed. My day time events would roll into my dreams & become so warped and I would wake up confused if what I dream was real or not.

By the Friday after I started taking Singulair I was experiencing anxiety. I felt like I had been drinking coffee all day (I don't usually drink coffee so when I do I get very anxious). By Saturday I was depressed. I didn't want to go out & socialize & I didn't want to be around my husband. I just sat on the couch with my mind spinning out of control with sad thoughts - for example - wondering why husband loved me, whether my parents were healthy & imagining what I would do if they died.

On that Sunday night I was laying down trying to go to bed & my right side was tingling. Since it wasn't the left side I didn't think much of it & tired to ignore it. It took me a long while to fall asleep that night because of worrying about the tingling sensation as well dreading what I was going to dream of. Well, I had the most messed up dream that night that I can't even talk about it without crying. I woke up at 3am & finally came to the realization that it could be the Singulair causing all these problems. I got on my computer & found this website.

Needless to say I stopped using Singulair immediately after reading these testimonials. I met with my doctor that next Tuesday & told her what happened & what I had read. She told me how she had just read the FDA report about 2 weeks before I saw her but didn't think too much of it because she prescribes Singulair about once or twice a week & has never has a patient complain about a mental side effect. I told her to be careful b/c these people may not know what is going on with them & may not be able to put 2 & 2 together b/c who would think an asthma & allergy medication would mess with their mind.

My doctor then prescribed me the Symbicort inhaler and I haven't used my albuterol inhaler once since I started using Symbicort. Mind you I have very mild asthma symptoms.

On January 13, 2009, the FDA released a Follow-up to their March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair). Included in this update is the following information:

"Post-marketing reports of neuropsychiatric events associated with montelukast, zafirlukast and zileuton have been reported to FDA’s Adverse Event Reporting System (AERS). Most of the reports of neuropsychiatric events are associated with montelukast, currently the most commonly prescribed drug that acts through the leukotriene pathway. The clinical details of some reports involving montelukast are consistent with a drug-induced effect. Because of the paucity of reports involving zafirlukast and zileuton, assessment of a drug–induced effect with these is limited. Accordingly, at this time, patients and prescribers should monitor for the possibility of neuropsychiatric events associated with these agents."

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.

Post-marketing reports of neuropsychiatric events associated with montelukast, zafirlukast and zileuton have been reported to FDA’s Adverse Event Reporting System (AERS). Most of the reports of neuropsychiatric events are associated with montelukast, currently the most commonly prescribed drug that acts through the leukotriene pathway. The clinical details of some reports involving montelukast are consistent with a drug-induced effect. Because of the paucity of reports involving zafirlukast and zileuton, assessment of a drug–induced effect with these is limited. Accordingly, at this time, patients and prescribes should monitor for the possibility of neuropsychiatric events associated with these agents..........................................This is the small print that is missing from some news reports

I was shocked last night on the news, when they reported that "there is no link between Singulair and suicide". I guess Merck is going to stick their heads in the sand, and let children continue to be harmed by a drug that I feel should never be prescribed to a child in the first place. I'm shocked at how young some of these children are! It makes me sad that Dr.'s, the FDA, and Merck will continue to put profit before the safety of the people being prescribed this drug and having terrible side effects from it...and most Dr.s are not fully aware of!!!!

If you know of anyone developing alopeica areata(hair loss which causes bald spots on the scalp) after receiving the Gardasil shot, please call and report to Merck at 1-800-444-2080. They must be made aware of all of the symptoms associated with this shot.

I have founded an advocacy group called Parents United for Pharmaceutical Safety and Accountability. The activities of this group will include supporting Kate and Dave Miller's efforts to initiate change in the adverse event reporting system and failed system of updated drug info notification to physicians and pharmacies, and to educate the public and motivate them to demand change too. Another activity will be to educate the public about the dangers of Singulair and how to spot adverse reactions. And finally, the biggie: putting pressure on the FDA to AT LEAST "black box" Singulair.

I personally wonder how many people out there have experienced adverse reactions to Singulair. At some point, if the FDA lets us down, I want the group to conduct its own study to determine this and maybe identify new adverse reaction?

Hopefully the website will go live next week. Anyone who wants to volunteer or give input is invited to sign up via a private message to me at this site. If you provide your email address I will contact you when the site goes live. If you would like to speak to me directly, send me your phone number and I will call you.

I have already contacted some of you directly, and if I have not yet gotten back to you, forgive me, I will.

Thanks in advance for any support you can give!

Jenna M.

I have already posted my side effects to Garasil previously...I have severe alopecia. This started over a year ago and is getting progressively worse. I just wanted to take a minute to urge all of you to do TWO things.

1) Submit your side effects to the FDA Vaccine Adverse Event Reporting System (VAERS); here's the link: https://secure.vaers.org/VaersDataEntryintro.htm

2) Call & report this to the MERCK National Service Center: 1-800-NSC MERCK (8am - 7pm ET)

Thank you for taking the time to do this, I know that it can be time consuming; but maybe we can prevent someone else from having the same miserable experience.

Hello Ladies,

I have posted several times before and thought I would add a few things. I have experienced the EXTREME weight gain and bloating in a very short time, sweats, migraines, problems with vision and contact lenses, chest pains, on and on. As with many of you, my side effects only got WORSE when I went off. I was only on for 5 months! I've been off since July 19 and I'm continuing to expand, which is SOOOOOO depressing.

Anyway, I've reported all of this to Berlex Labs and suggest you all do the same. I've also requested a call back from one of their "health care" professionals to see if they know of a recomended protocol to turn this monster around and get my body back. You can write me privately for contact info.

I'va also contacted FDA and the individual with whom I spoke was a very kind and understanding gentleman. He HIGHLY suggested we post our problems with YASMIN on FDA'S adverse event reporting system. I haven't done it yet but he said you just go to FDA.gov and on the right side click on "FDA activities", which will take you to their MEDWATCH site. This is where we should report our problems. This can be done directly on-line or copy and send a fax. If you send it online be sure to click "SUBMIT REPORT" at the top to be sure it goes through and you will receive a confirmation email.

I am FURIOUS that we've all been put through this and want to stop it for other women if possible. I understand that b/c pills have their share of consequences, but this one really takes the cake.

Blessings to you all,
Rita