Fda symptoms and conditions

My son has been taking Singular as well as Advair and Zyrtec and Nasonix for the past 6 months. He is doing so well. He has not had to go to emergency, he has not been sick, and he has not had mood swings. If you look at the prescription information that comes with Singular, you can see what the side effects can be. My recommendation is to take your child off of them if they have a side effect. I contacted my Dr. and Merck is studying only 1 case with a child that had side effects, but they did not say if this child was on other Psych medicine at the same time. The 2 psych meds that have shown a bad interaction with Singular are Phenobarbital and Rifanpin (spelling may be wrong). With all the posts I have read, very few people indicate if they are taking other medications at the same time as Singular. My suggestion is that you consult your Dr. and then send your case to Merck for more studies. If all you are doing is posting on the web, you are not solving this issue with the makers of the medication.

Dear Friends,

Just want to reconfirm that this drug, that according to the Lab, present this side effects as "rarely" now we can see that it is not, I have a 2.5 year old boy, that is presenting these same side effects that you are mentioning. In a sudden he starts to act really nervous, his eyes turn red and cries while he tries to express something, but he does not know what is going on, in the meantime he has this truly visible crisis, his heartbeat goes up like hell, and his hands shakes. My wife and I got really scared the first time we experienced this with him, and we did not know what to think, we asked the Doctor and the stupid guy told us that he needed a shrink, but we did not believed it. Today he had the second same crisis, not as hard as the last one, and we discussed and came up with the idea to find out what were the side effects of this drug, and voila, is the gdm Singulair. I just can't believe that the Doctors that are prescribing these drugs do not warn the people that this may happen. The only thing that I can do is write my experience to you, thanking you for your attention, and spread the voice to the other parents that are around me that they take care of this and prevent their children to go through this process. I really feel like trash, because I did not do this before starting giving him this drug. Thanks for listening.
By the way this is an international problem, I am writing you from Mexico City.

I've been on Singulair for more than a few years now. I'm 43, with exercise and allergy induced asthma.....but mild. I also have VERY bad allergies. Talk about being allergic to EVERYTHING outside....that's me. I also suffer from migraines and depression. I've been on every antidepressant out there....still depressed. Now I know why...Singulair. I've tried tons of migraine meds....and I'm wondering if some of my side effects are really from Singulair. I'm moody, I don't care about other people's feelings like I used to, I snap at my kids like crazy,I cry at the drop of a hat....at stupid stuff. And now I'm thinking that my joint pain in my hips is from Singulair. But Singulair was my miracle drug for my asthma and a huge help to my Allegra D for my allergies. I'm asking the doc for an alturnative drug. As soon as I get it I'm off Singulair. ADIOS!

My 16 year old son took Singular for three days. Almost immediately after taking the first dose, he starting having increased blood pressure, rapid heart beat, tiredness, depression, thoughts of death, muscle soreness, tingling in his arms and legs, numbness, weird dreams (when he was actually able to sleep) and decreased appetite. He seriously thought that he was going crazy. It was not until I did some internet research that I finally linked all of his symptoms to this horrible drug. He stopped taking it on Friday of last week and each day since has been feeling better. He is not 100% back to normal yet, but each day seems to be better. It was a scary three day period while he was using this medication. Hopefully it will only take another day or two to get out of his system completely.

To all the people who are just starting to make the connection between their symptoms and Levaquin or other fluoroquinolone antibiotic: There is a lot of information available on the internet. Check out the following websites: fluoroquinolones.org, antibiotics.org, medicationsense.org, fqvictims.org, fqresearch.org. There are also support groups on yahoo for sufferers. Please don't forget to file a medwatch report with the FDA. Finally the FDA is starting to listen to the victims!

I have had progressive muscle weakness, pain in my joints with swelling of the knees, ankles and hips. My doctor said it is not related to the antibiotic and to continue taking it. The symptoms are so disabling I can barely make it to the bathroom alone and I have had to miss work. I also told him the inside of my throat felt swollen, and my tongue is turning white. It just isn't a pleasant drug to be on.

Its hard to say for sure what people will experience with any of these drugs, but its nice to hear from you all.

I am looking at whether geodon or lamictal is causing me these horride nightmares.

It seems both drugs can.

I started taking catapres, which is a blodd pressure med that has an off-label use to control nightmares which helped quite a bit...

but beware...missing a dose or two of caterpress will give you a rather bad day, as it suppresses adrenaline...which causes nightmares.....so imagine what happens when this suppression suddenly stops???? BAD.

i am tapering off geodon, i had no issue with it, but being seroquel is the only FDA approved anti-psychotic med to treat depression/aniexty....i will find out soon if the geodon was causing the nightmares or the lamictal. i will post later.

just know- for me..tappering off geodon is not going pleasant for me.

my doctor said the drug rep even mentioned it had a high side effect profile...

Have taken 500mg Levaquin for 10 days on numerous ocassions to fight lung infections in between Cat Scan follow-ups for Lung Cancer since 2006.

Worked fine for my lungs, and I've been LC free for some time. Two months ago rt elbow swelled up, first like a mushy sack, now more firm, size of an egg, no pain then or now. Few weeks later Lt elbow began to swell but not as large and no pain. Dr. said wait few weeks and he'll refer me to surgeon. Now this FDA report on Levaquin has me wondering. I have full motion and no pain. Could this be a pre-cursor to possible tendon damage from Levaquin. Your input would be appreciated. Bill B

The following article in the WSJ may explain the reason for the significant number of Adverse Reactions to statin drugs.

Why You Can't Tell Where
Your Medication Was Made
April 8, 2008; Page D1- Wall Street Journal
Bananas come with those little stickers listing their country of origin. Why not pharmaceuticals?
That's what some consumers -- and even some physicians -- are asking since the Food and Drug Administration linked the deaths of 19 people to contaminated batches of the blood thinner heparin from China.
*******

I encourage every patient with a bad experience taking statins to contact the FDA (see, July 1, 2008 posting for FDA contact info).

The following article in the WSJ may explain the reason for the significant number of Adverse Reactions to statin drugs.

Why You Can't Tell Where
Your Medication Was Made
April 8, 2008; Page D1- Wall Street Journal
Bananas come with those little stickers listing their country of origin. Why not pharmaceuticals?
That's what some consumers -- and even some physicians -- are asking since the Food and Drug Administration linked the deaths of 19 people to contaminated batches of the blood thinner heparin from China.
******

I encourage every patient with a bad experience taking statins to contact the FDA (see, June 29, 2008 posting for FDA contact info).

My 3 years old daughter was on Singulair for 8 months, that was prescribed by her Pedestrian from the Asthma clinic in Canada, Quebec. Lately, some of the symptoms of adverse effects are surfacing in her, including depression, action very emotional, constant having bad dreams (which causes tiredness), crying almost whole day in the daycare, refusing to eat and drink, refusing to join her favorite activities... Her Pedestrian told us there is no side effect on Singulair when she renewed the prescription 2 days ago. Because of my doubt about that, I started research on the web and found out that the early communication was issued by FDA. Of course, I took my daughter off from Singulair right away.

I work in the drug development clinical research field. I know that nothing the FDA or Health Canada will pursue until a lot of cases on adverse events (side effects) reported to them. Please everyone, if you or your child has had developed any side effects on this particular drug (Singulair), please report to FDA at once. It got me so upset is that this drug is constantly and widerly prescribed to children, and the Pedestrians are not caution enough to tell the parents. I definitely do not want to see other children suffer the same symptoms as my daughter had.

I was prescribed Levaquin in Feb./March for 30 days. I have had tremendous pain in my heels since then. I am walking slower as every joint and muscle in my body hurts. I can barely stoop down and it is getting worse. I can not sleep. I thought I was just going through some depression and stress until I started reading about it in the WSJ and now realize I fit many of the symptoms being discussed.
We all need to take some action as this is only going to get worse for everyone.
FDA?????????????????

My husband has COPD and was prescribed Levaquin along with prednisone for bronchitis. He developed acute tendinitis in both achilles tendons and then the right achiiles totally ruptured about 6 weeks later. It has been a nightmare for him.

It is so important that everyone who has suffered an adverse affect report it to the FDA. Unless they receive these reports, they do not know how serious this problem really is and most doctors are totally oblivious.

It is quite amazing how when the story hits the news, the number of postings here jumps up! How sad it is that many people now realize the same things that many of us have known for quite some time. I only hope that the floodgate have now opened and that everyone will now keep the pressure on to limit the use of thee dangerous chemicals.

After 20 months I have had my right distal tendon surgically repaired, I endure tremendous pain in my left arm daily, and I fight the other unmentionable adrs. A black box warning is a start but it is not nearly enough.

New side effects: intense anger with the FDA and drug manufacturers, distrust of the medical community, and the required development of pain management skills.

My daughter has been off Singulair for approx 2 months and is back to her old self. Talkative and happy! How about contacting the media to see if they would be interested in doing a story on the problems that have been associated with this drug. Yesterday morning there was a story regarding the poor health of our children-high cholesterol etc, and my first thought hmm-wonder if they are on Singulair. I think if more light was put to this drug, maybe we could get answers faster.

Hello,
I have just found out about this and have been on cipro and levaquin and guess what. 2 weeks ago i was jumping in a pool and the tendon in my arch let loose. I went to the orthopedic doctor and he sent me for MRI then put me in a boot cast. It felt like i stood on a golf ball and it still hurts like hell. I have problems walking on it still. My doctor stated that i will most likely be flat foooted now in the foot that the tendon let loose. then i seen this on the news. Damn i have never had problems in my foot. He called planter facititus.

I am diagnosed with COPD. On March14, 2008, I visited my pulmonologist due to having a bacterial infection in the lungs and nose. I was given a script for Levaguin 750 mg for 7 days. After my first dose, my feet felt like they were on fire. I spoke with the pharmacist and he said it could be a side effect. I finished the meds with a lot of trepidation, feeling uneasy and anxious. However my large toes began to have a tingling sensation, which I reported to my PCP and he said to keep a check on it. I just came from my PCP today, July 8,2008 and now, in addition to my lung problem, I have peripheral neurophathy, involving all my toes and also my hands. This medicine is dangerous, as looking back at the time after I took this medicine, I was seriously considering ending it all! I will never take any medication in the future until I research it thoroughly. I trust my PCP and I trusted my pulmonologist, but I feel the pulmonologist should have informed me of the possible bad sich effects. Be careful out there!!!

All I can say is that when I heard that CIPRO and if I understand correctly LEVAQUIN will now have the "Black Box" warning, I thought THANK GOD. .I wonder how many people are "the box" from the drug and/or from committing suicide from this horrific drug?

THANK YOU, FDA, for listening to those who contacted you via letters and emails. Also, who knows? Maybe this board made a little bit of difference.

Either way, a warning is not a ban. I can't understand how Bextra could be pulled off the market and LEVAQUIN "lives all" to do more damage to some.

Pray for this drug to be further scrutinized and researched!!!!!!!!!!!!

Lipitor an all Statins deplete the natural enzymes from your muscles.
Your Heart is a muscle. I haved been on Lipitor for a number of years
with many of the side effects posted here. I have had Heart Failure fo
a year now and the best doctors could not help me. My son recently
researched an found a possible solution the indicated Statins deplete
th heart muscled of COQ10 a natural enzyme in the Heart Muscle.
This depletion over time can caused Heart failure due to weak walls.
Since my doctors could offer no solution, I decided to try it for 90 days.
I am off Lipitor an taking 400mg of COQ10 per day.
I am now in day seven an have slept in my own bed with my wife for the first time in a year. I am less restless, an have ha no recurrence of Heart Failure. The drug companies know the problems but thy have
deep pockets an the best lobby to get laws passed and FDA approvals.

They have now received approval to get kids on Statins so they can
make even more money before the patient run out. Thy should be ashamed but they are not!!

I am 24 years old and I had a pulmonary embolism last month. I was on the birth control YAZ for only 3 months, and that's what doctors seem to think caused it. My insurance only paid for me to be in the hospital for three daysand I was sent home with lovenox shots and Coumadin pills.

One month later, my INR is still unstable, fluctuating so much that they are checking it twice per week. My dosage is constantly changing. I have a red, painful rash on my buttocks - it hurts of sit for more than a few minutes. I am losing clumps of hair. I have lost my libido. I am very irritable and snap at my husband several times per day. I have a headache almost daily and frequent nausea.

I hate these side effects!

Besides feeling very strongly that YAZ should be taken off the market from mine and everyone elses complaints of lossing thier minds I also feel all these symptoms should be reported to the FDC, FDA, and APA. Please take time to report your concerns to the organizations that use them in the best ways possible maybe even help prevent others from your same expierence even if it is just w/ a label or warning change. Thank you, I'm just trying to help others.

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

Everyone make sure you report your ADR's to the FDA. Here is the link. It only takes a few minutes and maybe we can stop this. I have filled one out before but since I have ruptured another tendon I am filling another one out.
http://www.fda.gov/medwatch/

I'm seeing some posts from parents who say their children have returned to normal after discontinuing the use of this medication. However, there seem to be a lot of diagnosed "ADHD" or "BIPOLAR" conditions. Are your children really returned to normal? Or have they been diagnosed with a psychological issue and are receiving treatment? There seems to be a connection here, even after discontinued use, especially male adolescents. Any thoughts?? The increase in cases of ADD, ADHD, AUTISM, etc has been multiplying at a very disturbing rate in the last 10 years. I'm thinking definite connection to the "new" breed of "receptor blockers". What is it triggering? Any thoughts out there? Lets post anyone with similar cases and see how many are out there.