Asthma treatment symptoms and conditions

I URGE YOU TO PLEASE SUBMIT ANY ADVERSE EVENTS OF THIS TERRIBLE KENALOG DRUG TO THE FDA--JUST CLICK THIS LINK AND COMPLETE THE FORM: http://www.fda.gov/medwatch/. The FDA is responsible for assuring safety of medications. Therefore, it is imperative that the FDA recognize the adverse effects to provide any credibility to a class action suit. Please consider forwarding your case to the FDA to force them into action and begin addressing these atrocities.

Here's my case: I am also a victim of having the Kenalog injection administered over a year ago to alleviate poison ivy itching symptoms. Prior to having the injection, I was not informed of any side effects. Not only did the injection not alleviate the symptoms, but has resulted in a discolored and uncomfortable indentation in my left buttock area and psychological anguish because of disfigurement of my body. It is over a year later and the indent remains and continues to cause discomfort. The dermatologist who administered the injection stated that there was nothing I could do to reverse such effects. I reported my case to the FDA (Food and Drug Administration) Med Watch and strongly urge others to report their adverse event to the FDA (see link above).

I have a 4 year old whom was diagnosed with Asthma over this winter. She has always had coughing at night and Asthma treatment seemed to really work. We wanted to take her off the breathing treatments to build her system back up so she was given two months of Singulair. It seemed to work great. Asthma symptoms seemed to be controlled without puffers and nebulizers. However the last week which would be the 6th week on singulair she suddenly had severe separation anxiety. Even at Vacation Bible School which she loved and knew her teachers she had what I would call an anxiety attack which was completely not her normal disposition. I didn't put it together though until last night. She woke up and got in bed with me. After barely falling asleep about 3am she woke up screaming that there were bugs everywhere. She "saw" them and "heard" them and began slapping at her legs arms and face. At first I thought it was just a nightmare that I couldn't get her to wake up from. I put her in the shower and she still screamed. This went on through the rest of the night. She finally calmed down a little after an hour of histarics but still said she saw bugs. The more I thought about it I thought it may be the singulair and as soon as I searched for it I found this site. Needless to say she will not be taking this drug again. We will try to find some other way to treat her asthma. Thanks for all the insight.

I was just asked by Dr. ???, if these European reports lead to change in product information in these countries. I did post that I thought that we should try to find that out. I don't have access to that information. But I do see that the Netherlands did require that depression be added to the product information. It doesn't say the date but Merck agreed.

Artie wanted to tell us about the blood brain barrier. Where are you Artie?

The report says:

In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptoms before they started montelukast, the short latency, and recovery after withdrawal of the drug all strengthen our hypothesis that depressive symptoms are an ADR related to the use of montelukast. According to the Marketing Authorisation Holder of montelukast, depression will be added to the product information.

Mechanism: The mechanism of montelukast-induced depressive symptoms is unknown. However, montelukast has earlier been associated with adverse drug reactions such as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .

From the Netherlands 2006.

This is the html version of the file http://www.lareb.nl/documents/kwb_2006_4_montel.pdf.

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Nederlands Bijwerkingen Centrum LarebMei 2007Montelukast and depressive symptomsIntroductionMontelukast (Singulair®)is a leukotriene receptor antagonist available on the Dutchmarket since 1998. It is indicated for the treatment ofasthma as combination therapy forpatients with light to moderate forms of chronic asthma which cannot be adequately controlledby inhalation corticosteroids and short-acting ß-agonists. For asthma patients for whommontelukast is indicated as asthma treatment it can also relieve symptoms of seasonal allergicrhinitis. Montelukast is also indicated in asthma prevention, if exercise-inducedbronchoconstriction is the main factor

Reports On September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depressive reactions associated with theuse of montelukast.Patient A is a female aged 55 who used montelukast 10 mg once daily for asthma associated with COPD. Concomitant medication included ipratropiumbromideinhalation, salmeterol inhalation, fluticasone inhalation, acetylcysteine, budesonide nose spray and desloratadine. Two weeks after montelukast therapy was initiated the patient experienced nightmares, a depressive symptoms, fatigue and increased dyspnoea. When montelukast was withdrawn, the first three symptoms resolved. It is not known if the dyspnoea resolved. The reporting pneumonologist stated that the increased dyspnoea also could be a sign of progressing COPD. Patient B, reported by a pneumonologist, is a female aged 39 who used montelukast 10 mg once daily for asthma. Concomitant medication included salmeterol/fluticasone inhalation, mebeverine and psyllium seed. One week afterstarting montelukast treatment the patient experienced chest discomfort, malaise,depressive symptoms and dizziness. Montelukast was withdrawn, patient outcomeis unknown. Patient C, reported by a pharmacist, is a male aged 46 who used montelukast 10mg once daily for asthma. Concomitant medication included omeprazole,salbutamol inhalation and budesonide/formoterol inhalation. Six days after starting montelukast treatment the patient got in a depressed state. The patient continued to use montelukast for four weeks but the depression did not resolve. When montelukast was withdrawn, the patient recovered. Patient D, reported by a pharmacist, is a female aged 59 who used montelukast 10mg once daily for mild to moderate asthma. Concomitant medication included mometasone nose spray, salmeterol/fluticason inhalation, oxazepam and paroxetine. Three days after starting treatment with montelukast the patient experienced insomnia and aggravation of her depression. When montelukast was withdrawn the symptoms resolved.

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Nederlands Bijwerkingen Centrum LarebMei 2007 Other sources of information drugs are known to cause depressive symptoms. However montelukasthas not been associated with depressive symptoms earlier . A Medline searchbased on the MeSH terms montelukast, leukotriens, depressive disorder and mood disorders did not yield any relevant publication. DatabasesOn September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depression associated with the use ofmontelukast (ROR 2.1 95% CI 0.8 - 5.7). The same day the database of the WHO contained 3466 reports on montelukast, 43 of these concerned depression (ROR1.2 95% CI 0.9 – 1.6)MechanismThe mechanism of montelukast-induced depressive symptoms is unknown.However montelukast has earlier been associated with adverse drug reactions such as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .Discussion and conclusionLareb received four reports of depressive symptoms in patients using montelukast.Possible confounding includes that asthma itself has been associated with the development of depression . Inhalated corticosteroids can also exert effects onthe central nervous system. Fluticason in combination with salmeterol which isused by patients A, B and D, is associated with hyperactivity and irritability where as budesonide, which is used by patient C also has been associated with depression . The latency of montelukast-induced depressive symptoms variesfrom 3-14 days. In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptomsbefore they started montelukast, the short latency, and recovery after withdrawal ofthe drug all strengthen our hypothesis that depressive symptoms are an ADRrelated to the use of montelukast. According to the Marketing Authorisation Holderof montelukast, depression will be added to the product information.

From the Netherlands 2006.

This is the html version of the file http://www.lareb.nl/documents/kwb_2006_4_montel.pdf.

Page 1
Nederlands Bijwerkingen Centrum LarebMei 2007Montelukast and depressive symptomsIntroductionMontelukast (Singulair®)is a leukotriene receptor antagonist available on the Dutchmarket since 1998. It is indicated for the treatment ofasthma as combination therapy forpatients with light to moderate forms of chronic asthma which cannot be adequately controlledby inhalation corticosteroids and short-acting ß-agonists. For asthma patients for whommontelukast is indicated as asthma treatment it can also relieve symptoms of seasonal allergicrhinitis. Montelukast is also indicated in asthma prevention, if exercise-inducedbronchoconstriction is the main factor

.ReportsOn September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depressive reactions associated with theuse of montelukast.Patient A is a female aged 55 who used montelukast 10 mg once daily for asthmaassociated with COPD. Concomitant medication included ipratropiumbromideinhalation, salmeterol inhalation, fluticasone inhalation, acetylcysteine, budesonide nose spray and desloratadine. Two weeks after montelukast therapy was initiated the patient experienced nightmares, a depressive symptoms, fatigue and increaseddyspnoea. When montelukast was withdrawn, the first three symptoms resolved. Itis not known if the dyspnoea resolved. The reporting pneumonologist stated thatthe increased dyspnoea also could be a sign of progressing COPD.Patient B, reported by a pneumonologist, is a female aged 39 who used montelukast 10 mg once daily for asthma. Concomitant medication included salmeterol/fluticasone inhalation, mebeverine and psyllium seed. One week afterstarting montelukast treatment the patient experienced chest discomfort, malaise,depressive symptoms and dizziness. Montelukast was withdrawn, patient outcomeis unknown.Patient C, reported by a pharmacist, is a male aged 46 who used montelukast 10mg once daily for asthma. Concomitant medication included omeprazole,salbutamol inhalation and budesonide/formoterol inhalation. Six days after startingmontelukast treatment the patient got in a depressed state. The patient continued to use montelukast for four weeks but the depression did not resolve. Whenmontelukast was withdrawn, the patient recovered.Patient D, reported by a pharmacist, is a female aged 59 who used montelukast 10mg once daily for mild to moderate asthma. Concomitant medication included mometasone nose spray, salmeterol/fluticason inhalation, oxazepam and paroxetine. Three days after starting treatment with montelukast the patientexperienced insomnia and aggravation of her depression. When montelukast waswithdrawn the symptoms resolved.
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Nederlands Bijwerkingen Centrum LarebMei 2007Other sources of informationLiteratureSeveral drugs are known to cause depressive symptoms. However montelukasthas not been associated with depressive symptoms earlier . A Medline searchbased on the MeSH terms montelukast, leukotriens, depressive disorder and mooddisorders did not yield any relevant publication.DatabasesOn September 20, 2006 the database of the Netherlands Pharmacovigilance Centre Lareb contained four reports of depression associated with the use ofmontelukast (ROR 2.1 95% CI 0.8 - 5.7). The same day the database of the WHOcontained 3466 reports on montelukast, 43 of these concerned depression (ROR1.2 95% CI 0.9 – 1.6)MechanismThe mechanism of montelukast-induced depressive symptoms is unknown.However montelukast has earlier been associated with adverse drug reactionssuch as abnormal dreaming, nightmares, hallucinations, agitation with aggressive behavior, irritability and restlessness, which suggests that montelukast can penetrate the blood brain barrier and exert an effect in the brain .Discussion and conclusionLareb received four reports of depressive symptoms in patients using montelukast.Possible confounding includes that asthma itself has been associated with the development of depression . Inhalated corticosteroids can also exert effects onthe central nervous system. Fluticason in combination with salmeterol which isused by patients A, B and D, is associated with hyperactivity and irritability where as budesonide, which is used by patient C also has been associated with depression . The latency of montelukast-induced depressive symptoms variesfrom 3-14 days. In three of the cases a positive dechallenge was seen.The fact that the patients (except for one) did not suffer from depressive symptomsbefore they started montelukast, the short latency, and recovery after withdrawal ofthe drug all strengthen our hypothesis that depressive symptoms are an ADRrelated to the use of montelukast. According to the Marketing Authorisation Holderof montelukast, depression will be added to the product information.References1. Dutch SPC Singulair®. (version date 11-7-2005) http://www.cbg-meb.nl/IB-teksten/23164.pdf.2. M.N.G Dukes and J.K Aronson, editors. Meyler's Side Effects of Drugs. 14 ed. Elsevier; 2000.3. Price D. Tolerability of montelukast. Drugs 2000;59 Suppl 1:35-42.4. Goldney RD, Ruffin R, Fisher LJ, Wilson DH. Asthma symptoms associated with depression and lower qualityof life: a population survey. Med J Aust. 2003;178(9):437-41.5. Dutch SPC Seretide®. (version date 12-8-2005) http://www.cbg-meb.nl/IB-teksten/23529-23530-23531.pdf.6. Dutch SPC Pulmicort®. (version date 20-10-2003) http://www.cbg-meb.nl.
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Nederlands Bijwerkingen Centrum LarebMei 2007

5 year olds do not talk about suicide...period!!!

My child was on no other medications. I have reported this to Merck and the FDA and have also changed pediatricians after a lengthy discussion with her. I cannot speak for others.

The issues with Singulair are far from over. Stay tuned.

My child started Singulair when he was seven and has been on it for 1 1/2 years. He has since had to go on anti-depressants and weekly visits with behavioral pediatrician. It has been so painful to hear my once very happy child saying, "I wish I were never born, why did you have to have me?" I have received calls from the guidance counselor asking about his anger problems and I really had no reason as to why he had become this way. I blamed it perhaps on the difficult time he has had sleeping, 3 or more hours to fall asleep. It is all coming together now. How tragic that my child has suffered this way and his asthma treatment was to blame.

My sister was prescribed Avelox on Tuesday, March 11, 2008. Within 15-20 minutes she began having breathing difficulties. Because she has asthma her initial thought was that she was having an asthma attack. She tried asthma treatment and it didn't help. She soon was unable to breath. Her husband called 911, they responded quickly but had to intubate her in the ambulance. They know that she was without oxygen to her brain for at least 3-5 minutes. This caused seizures that lasted 20 hours before I.C.U. could get them under control. Unfortunately it caused brain damage leaving her with no higher brain function (vegetative state). As she has worked in the medical field for over 14 years she did not wish to be kept alive by artificial means. On Tuesday, March 18, 2008 her ventilation tube and feeding tube were removed. It is now Thursday, March 20, 2008 and she is in a wonderful Hospice House awaiting her death.
She had taken the same class of antibiotic in the past with no reaction. Really not sure what caused this one. She was going through chemo for breast cancer, but had just finished and was scheduled to start her radiation treatment. Her chemo doctor told us that since her reaction, they have had another patient who went into anaphylactic shock after taking Avelox.
My sister is only 43 years old. This medication should be taken off the market.

Feeling like one is not all here, and, shortness of breath are a symptoms of thyroid system problems caused by lisinopril that I have had, along with weight gain, favoring sweet sugary foods (I've traditionally a meat eater, no dessert, no sugar, few starches).

The most likely action seems to be that the lisinopril creates a chemical toxicity that overdrives the immune system, which then runs the body low on or out of zinc and selenium. (Of course then there is the more direct lung dammage that lisinopril causes too.)

I have found the following helpful: Zinc, selenium, L-Cysteine, tyrosine, iodine, boron, and other trace minerals help and nourish the thyroid system. Manganese and molybdebum help the lungs function better (they are used in asthma treatment). Iron, copper, and chromium sometimes also helps the lungs work better. Sulfur (MSM), L-cysteine, and silcia (found in horsetail form or oceanic form) nourish the lungs as they are found in high concentration in the lungs. Calcium and magnesium, vit-e, vit-c, vit-b are also helpful. Since I'm in the hbp camp, I also try to get plenty of magnesium, which relaxes muscles including arteries, and potassium, which helps transport other nutrients into the cells.