Cder symptoms and conditions

I have been taking Singulair for one week now due to my exercise induced asthma and allergic asthmatic symptoms. I feel very stressed out and anxious and yell at my parents a lot. Also, I feel kind of paranoid, like I feel as if somebody is watching me at all times. It is scary because I've only been on it a week. Also, my face is red and blotchy and my acne has gone from very little bumps to full blown breakouts all over. I have a barking cough and runny nose now that the doctor prescribed it. When I cough I have a pain on my left side that feels like someone is stabbing me.

Consumer Medication Information (CMI) distributed by pharmacies with prescriptions is NOT regulated by the FDA and may not contain a complete list of side effects from the medication's FDA approved label.

CMI is usually stapled to the prescription bag or inside it and is often produced by private companies that provide this information to pharmacies. It is different than a medication guide or patient package insert, which are FDA approved, published by drug manufacturers, and and required to be distributed with certain medications.

You can get accurate medication side effect information from the United States National Library of Medicine's DailyMed website.

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!!!!

On the fda;s cder web site is a calender of meetings,there is also a calender for tentative meetings,tentively scheduled on dec 10 and 11 is a meeting of asthma allergy,risk management and drug safety,we know they hired public relations so we wonder if maybe they will be there,as this investigation comes to an end,i wonder is there more we could have done,i don't think so,i am perturbed that we were not contacted after we filed our reports,as i wonder how they will get the rest of the story.It is my understanding that these meetings are open to the public,unless otherwise specified,there is no specification on this one yet,i hope if any one is in the Dc area and they have a chance to go they will tell us what is said.I hope they look into the chances of some having maybe perm issues and give us guidance,they have been silent for so long as we have battled this in the dark.If by scheduling this meeting the investigation is over and they have a conclusion and our not going public yet ,well shame on them,if there is one thing we are disparate for is information as to what to do next,heres hoping every one,keep fighting

EVERYONE PLEASE READ!!!! GARDASIL HAS DESTROYED MY LIFE! I am 24 years old and a year and a half ago I was graduating college and planning to be a professional dancer and go to law school...I was perfectly healthy and energetic! In February of 2007 I received my first Gardasil shot. After a few days I started to feel as though I had a Urinary Tract Infection and was also feeling more tired than usual. The doctor gave me an antibiotic and sent me on my way.

In May of 2007 I received my second Gardasil shot and yet again, a few days later I started to feel like I was getting another Urinary Tract Infection. I went to the doctor numerous times between the second and third shot...all for bladder and urinary tract pain. For months I was on different antibiotics and they were not making the pain go away. After visiting a number of urologists, I found out that the urine cultures had all been coming back negative - showing no sign of an infection, so the antibiotics were pointless. All tests that I had run, both blood and urine came back normal. It is not standard procedure for a doctor to call you if your test results come back normal, but there was clearly something wrong, so I searched for a urologist who would believe me that I wasn't making up the pain I was in.

In August 2007, I had a cystoscopy done (they took a scope and went into the bladder to look in the bladder wall) and they concluded that I have an incurable bladder disease called Interstitial Cystitis. This is a condition where there becomes a defect in the bladder wall causing it not to have the protective mucus layer inside of it. The pictures of inside my bladder show red, raw skin, obviously showing the severity of my case of it.

There is no evidence as to what causes Interstitial Cystitis, and there is no proven successful way of treating it. The initial signs are exactly the same as a Urinary Tract Infection (painful bladder spasms, painful urination, body aches and back pain). The main difference is the fact that it is not an infection. There are thousands of people with Interstitial Cystitis who are misdiagnosed as having chronic Urinary Tract Infections.

I received my third Gardasil shot in October of 2007 and that is when EVERYTHING fell apart. The bladder pain became constant and there has not been one minute in a day since that shot I have not been in unbearable pain. This is when everything else in my body began to crash down as well. The other health problems and side effects from the Gardasil that I am having are constant sore throat, vicious migraines, vision changes, back pain, body aches, joint pain, sinus problems, vomiting, constipation, dizziness...I could keep going on forever!

I have tried all of the conventional treatment for Interstitial Cystitis and have gotten NO relief from the pain and other side effects. The doctors didn't know what to do, so they put me on OxyContin and a diet consisting of no acidic foods. That has now posed its own set of problems seeing as now my body is addicted to the narcotic, and I have gone from 5'6'' 125lbs to 100lbs over the course of a year due to the diet. I am extremely malnourished and have to take B12 vitamin shots once a week due to the severe anemia. I am 24 years old, and feel like I am 100. I can not live a normal life, I am going to lose my job from numerous absences, I lost my fiancé and am not able to have an intimate relationship anymore, I am extremely depressed, I have to have my family clean my apartment because I am too sick to do it, I can not do social activities because I am too tired and in pain. This vaccine has DESTROYED my life! I am desperately seeking out someone else who is having bladder problems due to the Gardasil so that I can contact an attorney. This needs to be OFF the market a soon as possible so that it does not run any other lives! Gardasil has caused some deaths, but in my mind, I'd rather die than live with the pain I am having. I did notice there are some posts regarding girls getting urinary tract infections... PLEASE PLEASE PLEASE have your urine cultured because there is a good chance it may be Interstitial Cystitis!

I am desperately looking for someone who is having some of these symptoms so that I can go to a lawyer and get something going before things like this happen: Numerous states are pushing to make it mandatory that girls receive the vaccine before they enter the 6th grade. We can not let this happen! We all need to stick together and somehow fight this and get out lives back!

Let me know if you are IN - and also what you thought about my post!

You can email me at ******

Bless All of You!

*~Amber~*

Who administers this site? I posted a side effect last night after I registered and then this morning I got an email saying there was a reply to my posting and when I tried to log in, my account was inactive and my posting had been removed, as had the reply to my posting. I don't know if it is because I put a link the an online reporting tool where the FDA is compiling feedback from people/or their children who have experienced terrible side-effects. Here is the link again and I urge you all to report your cases: http://www.fda.gov/cder/drug/early_comm/montelukast.htm

My son is 3.5 and has been on Singular for 2 months and just like all of the other stories about the other young children posted here, he is a different kid after being on Singular. Last night was the first night I took him off of it. All of the side-effects that are mentioned here are the same ones my son is experiencing, nightmares (screaming in the night), hyper, aggressive, reliving injuries from days past, the day care telling me that they now have concerns about how different he has been lately and the even used the term "bad behavior". They said he is hyper, he screams, not listening, aggressive. He is a favorite at day care since he is so loving, polite and kind. I know all parents say that, but pretty much anyone who has met him compliments me on how well behaved he is. I am even nervous to have people over since he seems out of control and I have found myself ensuring people that he isn't normally like this. I have taken him off as of last night and I am hoping he will get back to his old happy-go-lucky self soon. Does anyone know how long it can take to get this poison out of their system? I pray that there are no permanent side-effects.

I took my son off Singular a month ago, some slight improvements with the sleep and behavior problems. I voiced my concerns with my doctor twice now he looks at me like Im crazy and then he goes on the PC and says he cant find any of these side affects im talking about. My son was an appointment to see an allergist specialist.

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

It's important that you report your side effects to MedWatch under the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). The phone number for CDER is (301) 594-0104. From a conversation with someone in CDER, they review the number of complaints they receive for a particular drug, and then the complaints are reviewed by the Drug Safety Oversight Board to determine if the drug should be pulled. If you do not report your side effects to FDA, they can claim they do not have enough complaints to warrant action.

On the FDA site go to "MedWatch" and report your side effects.

Below is a list of the persons in charge of CDER. All persons listed below can be reached through the number above.

The person overseeing the Safety Policy and Communications staff is:

Paul Seligman
(301) 594-5493 (FAX)

The person overseeing MedWatch is:

Norman Marks
(301) 594-6197 (FAX)

The person overseeing the Drug Safety Oversight Board is:

Susan Cummins
(301) 594-5493 (FAX)