January 15th
2009
2:14 PM
To clear up any misunderstanding about the FDA Singulair investigation.
FROM THE FDA STATEMENT ABOUT THE SINGULAIR INVESTIGATION
"FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton."
"although (the clinical trial) data do not suggest that montelukast, zafirlukast, or zileuton are associated with suicide or suicidal behavior, these clinical trials were not designed specifically to examine neuropsychiatric events. As a result, some events may not have been reported."
The FDA is continuing to investigate a link between Singulair and suicide .
They stated that they have not "closed the book on suicidality". Any news reports stating there is no conclusive link are incorrect.
January 15th
2009
10:37 AM
I want to post this because this site has given me good perspective on this Rx and side effects experienced by others; its good to know I am not alone. As far as an agenda, I have none, in fact I was all for the Singulair initially, because it seemed to be a good alternative to inhaled steriods which I had read could interfere with normal growth. My son, 4 yrs. old, with a diagnosis of Asthma, started Singulair about 2 weeks ago. Asthma seems to have been improved by Singulair. Within a couple days of starting it, though, he reported vivid (but not nightmare-ish) dreams, a week later he dropped his afternoon nap, which we were expecting to happen eventually, so didn't think much of it. He is a wild child generally, but we also noticed an uptick in bad and aggressive behavior within a day or two of starting the Singulair; we really clamped down on him though, so that effect has been somewhat muted. He has always occasionally complained of indigestion stomach aches, but these complaints have increased to several times a day in the last week, also complain of lower abdominal pain which he says is "different" than his earlier indigestion stomach aches. Last week or so he's been up late at night, had trouble going to sleep, looks a little pale with dark circles under his eyes ("he's becoming a Goth" I joked with my wife). Last night he got out of bed late, appeared disoriented and seemed to be half awake, half asleep. He was talking, but not making sense and seemed to be upset and/or confused, but when pressed he assurred me nothing was wrong and nothing hurt--put him back to bed and this morning he remembers getting up, but also keeps telling me he had a "weird" (not scarry) dream and that he keeps seeing it while he's awake. Luckily this weird dream was not scarry for him, but he was clearly a little freaked out by seeing it again this morning. He seemed o.k. heading off to preschool, but we are taking him off the Singulair as a precaution. My advice to anyone else out there seeing similar symptoms in their kids is to go with your gut -- I always tell people that a Doctor's job is to tell you the odds, like only 1 in 500 or 1 in 1000 kids will have a certain reaction, or condition, or illness, it is the parents' job to be sure that their kid is not that 1. So I'm taking my kid off the Singulair because I think he may be that 1 kid who experiences these unusual side-effects. How wide spread they are, I have no idea. I will get on my soapbox and say I think it's time for the FDA to require drug companies to conduct long and short term clinical studies on kids for any drug that will be prescribed to kids--entrusting our childrens' health and well being to a drug company's own short term study conducted on fully developed adults is foolish and insane.
-- By chwaterman | Reply | (3) replies | Private Message me
January 15th
2009
9:35 AM
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!!!!
-- By froglover1069 | Reply | (3) replies | Private Message me
October 15th
2008
11:12 AM
d27gayle POSTED INCORRECT INFORMATION ABOUT THE SIDE EFFECTS OF SINGULAIR. I JUST COPIED THIS FROM MERCK'S SINGULAIR WEBSITE. THIS IS THE CORRECT AND UPDATED INFORMATION. THIS INFORMATION DOES LIST DEPRESSION AND SUICIDAL BEHAVIOR AS SIDE EFFECTS.
IF PEOPLE ARE GOING TO SHARE INFORMATION ON THIS SITE, PLEASE MAKE SURE IT IS CORRECT BEFORE POSTING!!!!!!!!!
What are the possible side effects of SINGULAIR?
The side effects of SINGULAIR are usually mild, and generally did not cause patients to stop taking their medicine. The side effects in patients treated with SINGULAIR were similar in type and frequency to side effects in patients who were given a placebo (a pill containing no medicine).
The most common side effects with SINGULAIR include:
• stomach pain
• stomach or intestinal upset
• heartburn
• tiredness
• fever
• stuffy nose
• cough
• flu
• upper respiratory infection
dizziness
• headache
• rash
Less common side effects that have happened with SINGULAIR include:
• increased bleeding tendency
• allergic reactions
• behavior and mood related changes
• drowsiness, pins and needles/numbness, seizures (convulsions or fits)
• palpitations
• nose bleed
• diarrhea, indigestion, inflammation of the pancreas, nausea, vomiting
• hepatitis
• bruising
• joint pain, muscle aches and muscle cramps
• swelling
Rarely, asthmatic patients taking SINGULAIR have experienced a condition that includes certain
symptoms that do not go away or that get worse. These occur usually, but not always, in patients who
were taking steroid pills by mouth for asthma and those steroids were being slowly lowered or stopped.
Although SINGULAIR has not been shown to cause this condition, you must tell your doctor right
away if you get one or more of these symptoms:
• a feeling of pins and needles or numbness of arms or legs
• a flu-like illness
• rash
• severe inflammation (pain and swelling) of the sinuses (sinusitis)
These are not all the possible side effects of SINGULAIR. For more information ask your doctor or pharmacist. Talk to your doctor if you think you have side effects from taking SINGULAIR.
-- By zsmom | Reply | (3) replies | Private Message me
June 20th
2008
10:51 AM
This testimony should help strengthen our case for warnings for Singulair.
Neurologist Sought Warning for Pfizer Drug
By JEREMY SINGER-VINE
June 20, 2008; Page B10
A British neurologist who analyzed effects of the drug Neurontin told a court hearing Thursday that he advised its maker -- now a unit of Pfizer Inc. -- to include a warning on the drug's label for potential side effects of depression and aggression, but his advice wasn't followed.
The University of London neurologist, Michael R. Trimble, was testifying at a hearing to decide whether civil cases brought against Pfizer alleging suicides linked to Neurontin can proceed. The hearing was jointly held by judges for U.S. District Court in Boston and a New York state court who are hearing similar cases. In various lawsuits consolidated in the federal court, plaintiffs allege more than 100 suicides were connected to Neurontin usage.
Dr. Trimble described what he said was a "plausible biological pathway" that could lead from the compound gabapentin -- the chemical name for Neurontin -- to suicidal behavior, hostility, and aggression. Dr. Trimble said that in 1995 and 1996, he was hired to write two confidential reports for Parke-Davis -- now a unit of Pfizer -- because the company "was concerned about psychosis in relation to their drug." Dr. Trimble said he was unable to find a link to psychosis, but noted effects of depression and aggression.
Lawyers for Pfizer argued at the hearing that the evidence linking the drug to suicidal side effects wasn't scientifically sound. Under cross-examination, they challenged his description of a pathway as a patchwork of studies that didn't prove a biological connection. Neurontin and generic forms of gabapentin are approved for treating epileptic convulsions, but have also been prescribed widely "off label" for other conditions.
In five of nine patient cases he analyzed in 1996, Dr. Trimble said he saw depression and aggression in patients who had no previous symptoms of the side effects, so he said he recommended to the company that the drug "should carry some kind of warning" for susceptible patients.
Thursday's proceedings were the initial phase of a hearing requested by Pfizer to challenge the opinions of the plaintiffs' experts. Under cross-examination and a subsequent examination by the plaintiffs' attorney, Dr. Trimble said the biological pathway between Pfizer's Neurontin and suicidal events were plausible and supported by a series of peer-reviewed neurology research.
-- By concernedcitizen | Reply | (3) replies | Private Message me
April 3th
2008
9:38 PM
My 8 year old son began experiencing depression, aggression and suicidal behavior in the past two months (on Singulair since age 4). I immediately took him off of Singulair 4 days ago and I see a change already. He is smiling, laughing and singing again. He's had meltdowns (crying, tantrums, etc) since age 4, but I never suspected the drugs. I HAVEN'T SEEN ANY CRYING OR TANTRUMS IN 4 DAYS! We'll see if the change in behavior "sticks." After reading everything on this site, I have a feeling it will.
-- By nonstop934 | Reply | (1) replies | Private Message me
March 28th
2008
5:51 PM
WASHINGTON (Reuters) - U.S. health regulators are probing a possible connection between Merck & Co Inc's blockbuster Singulair asthma drug and suicidal behavior in adults and children, the Food and Drug Administration said on Thursday.
The persons who have no symptomatic effects are so fortunate with Singulair. A medicine out in circulation abusing one's emotions, lifestyle, threatening life is a circumference, detrimental side effect.
-- By piky | Reply | Private Message me
January 24th
2008
5:39 PM
My son will be 4 next month he was only on Singulair for a month and a half to control his asthma and it has been such a stressful and sad nightmare for me as his mom. He was always been a smart and sweet kid, really calm and had a great attention span now after Singulair I feel like someone took my son and I can't get him back. His behavior is sporadic he has no attention span he can't sit still he has had leg pain, no appetite, not even for his favorite foods. He is about to be kicked out from his preschool because he has shown heightened levels of aggression for no reason and I don't know what to do. The pediatrician tells me that he has been off it for 9 days and it should be out of his system I don't believe it and I'm wondering when my son will be normal again. I feel terrible disciplining him because I feel like its not his fault its this medication that I didn't want to give him in the first place and I regret trusting her because of what its done to my son. There has to be a way to issue some kind of warning or lawsuit against this company this medication is NOT FOR CHILDREN! Please don't give it to your children.
-- By josiahz_mommy | Reply | (1) replies | Private Message me
May 15th
2007
5:00 PM
My daughter is 5 years old and has been on singulair for 1 week. i have already noticed a dramatic change in her behavior. she has become irritable, mean, nasty, and emotional. she has had me in tears on a daily basis. she has turned into a monster. we will be calling the doctor in the morning!
-- By lessa621 | Reply | (45) replies | Private Message me
January 16th
2009
4:49 PM
I am 34 years old. I am a pharmacy tech. I have asthma and allergies. I have taken singulair pretty much every day since it came out on the market. I've had asthma since i was about 10 years old. I took theophylline as a kid. Steriods on and off especially during times when my allergies are bad. I still use Advair during the fall and spring. Every drug has a side effect. However breathing is pretty good damn thing. Do I have days when I feel low? Yeah. Do I sometimes have nightmares? Yup. Are "natural" products the answer. Not always. The fish oil that some of the posters are touting can also cause GI problems. Some of the natural products contain herbs and other plant derivatives that can be harmful for a child that suffers from allergies. Not proactively treating asthma can be deadly. Some of the parents are suggesting steriods as the answer - those can cause weight gain, growth suppression and can lead to a worsening of asthma.
Singulair has never made me feel like I've wanted to kill myself. I was more depressed and angry as kid when my asthma did not allow me to partipate in normal childhood things. I was sad and hated life when I couldn't keep up with friends at recces because I was having trouble breathing. You have to outweigh the costs with the benefits. I am more irritable when I have asthma flareup then I am on a normal day. For me, I choose to breathe. And singulair has been helping me for almost a decade.
I'm not saying the medication isn't causing these symptoms but maybe there is an underlying cause to your child's depression.
Any drug has a side effect. But without medical research and the medications that come with them - people would still be dying of simple diseases and we wouldn't have vaccinations. As a society, as a whole, we are a culture that looks to someone else to fix things and then blames the people who try to fix it. We need to stop being the "hot McDonald's coffee'" society.
-- By vabenavidez | Reply | (23) replies | Private Message me