Asthma drugs symptoms and conditions

I have had life-threatening spasmodic breathing episodes for the last year. My GP attributed it to asthma, because that's what it looked like, and they have given me prednisone shots and later on, antibiotic shots, to control it (for about 6 weeks at a time). I have well-controlled type II diabetes, so predisone can cause it to go out of control fairly quickly. Prednisone also caused some occasional pain in my feet, probably because of the elevated blood sugar. All the asthma drugs they gave me actually made me sicker, like Advair, etc. Lo and behold, I was able to talk my doctor into a referral to an allergist, and my allergy numbers are off the charts! All grasses, most trees, and many animals were high enough to cause anaphylaxis, especially when surrounded by more than one. Anaphylaxis can cause the labored breathing I suffered. Meanwhile, I have the lung capacity of an Olympic swimmer. I have an elderly friend who has gone to the hospital several times this year with the same problem. After I found out my results, I talked to his wife, and they discussed the allergy and infection aspect with the doctor. Turns out he had fairly severe allergies and infections that made his life-long asthma go way out of control. With a medicine for infection, he is 10 times better - the asthma is under control because it is not being jump-started by the low-level infections he suffered. I don't even have asthma, it just looks like asthma. I will begin years of allergy shots, just like in my 20's. (I am 55). The upshoot? Some people are suffering severe asthma symptoms. Others have a combo of problems which are exacerbating the asthma-like problems. Doctors who think you only have asthma tend to only treat asthma. Prednisone greatly reduces inflammation, which is a common factor in all the above diseases. So, calming the symptom doesn't mean treating the source. You long-term asthmatics should also look inot taking allergy tests if it is considered safe (they DO inject a small amount of allergens in your skin), and not spend 100% of your time with the pulmonary specialist who is only looking at your lungs. Also, you really need to do some cause and effect testing with antibiotics or similar to see if you have some type of infection. My friend and I are both on our way to better health because we went beyond treating the symptoms.

From the FDA's "Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)"

6/12/2009

Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling).

Montelukast is used to treat asthma, and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma.

The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.

This information reflects FDA’s current analysis of available data concerning this drug.

Advice to patients and healthcare professionals:

Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.

Patients should talk with their healthcare providers if these events occur.

Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

Background

In April 2009, FDA completed its review of neuropsychiatric events, (mood and behavioral changes) possibly related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for these products.

The post-market reports of patients on these medications included cases of neuropsychiatric events. Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.

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To get the real information in regards to what level of research that is going into this investigation is.go to the Institute for Safe medicine practices click on Quarter watch.
To people like chris555, I believe you are engaging people for sport and say very hurtful things,your day will come and it may just be in the unemployment line.I can only imagine that you must work for Merck or you would not feel so threatened by the good that has come from Parents advocating for their childrens safety.I want you to know, that all who knew our family and our child understand what took place and our reasons for trying to get the proper information where it should have been," on the label". When our child died no one knew about all the added side effects from post marketing reports,which is "a reliable way to track a drugs adverse events".Maybe you should do more research on the legitimate information of causal relationship. Don't be so afraid of a possible drop in revenue for the drug company that I believe you might be an employee of.K. M.

I lead music for a children's choir and noticed my voice getting weaker over the past year, to the point I could no longer sing. Then my speaking voice got raspy as well, almost like laryngitis. Went to the doctor, and he told me to get off Advair immediately, replacing it with a liquid inhaler. That started to improve my voice for about a week, then my voice almost left entirely. I had to get off all asthma meds at that point, but what to do when one grows accustomed to breathing?

I am a hiker. The doc knew that. He suggested I focus on more hills to increase my lung capacity. I did my homework I made the following drink when I'd get up in the morning: 1 glass full of ice and some water, about an inch from the top. 1 heaping teaspoon of unsweetened cocoa (caffeine helps asthma and i like chocolate) 1 handful of chopped dates and here is the important ingredient - 1 full dropper of mullein oil, found at health food stores. Mullein opens my airwaves in about 2 minutes. I drink this weird shake and have no problems with my breathing and am off all other asthma meds. Asthma varies in people, as does severity, body type, health history, etc.

I hope this may help someone who would like to stop the asthma drugs and still be able to breathe.

I'm 18 years old and I've been taking Advair (500) for about 4 years. I've had very persistant asthma my whole life and my Advair seems to save me from having to use my albuterol around 6 times a day. About 9 months ago i lost my voice for over 2 months. After that went away I had a break for about one month then around 6 months ago I developed what seems like a smokers cough yet I don't smoke. I just got a chest x-ray done and they said it was normal. They put me on steroids and antibiotics but it doesn't seem to be helping.

Could it be the Advair? I don't know that I can go without it even if it is. I want to get rid of this congestion in my lungs. I'm sick of coughing up mucus daily. Does anyone have any advice?

Here is the list of asthma drugs mentioned.

Flovent- growth velocity reduction in children/adolescents, Agitation, aggression, depression, and restlessness. Asthma exacerbation, bronchospasm, chest tightness, cough, dyspnea, immediate bronchospasm, paradoxical bronchospasm, pneumonia, and wheeze. Upper respiratory infection, influenza, Nausea and vomiting, diarrhea, dyspepsia and stomach disorder. weakness, tired feeling, nausea, loss of appetite, weight loss, changes in the shape or location of body fat,

Advair - asthma-related death, Agitation, aggression, anxiety, depression. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children. Muscle injuries, fractures, wounds and lacerations, contusions and hematomas, burns, Rhinorrhea/postnasal drip; ear, nose, and throat infections; ear signs and symptoms; nasal signs and symptoms; nasal sinus disorders; rhinitis; sneezing; nasal irritation; blood in nasal mucosa. Sleep disorders, tremors, hypnagogic effects, compressed nerve syndromes, Cushing syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism, hyperglycemia, weight gain, osteoporosis

Albuterol - Dizziness; headache; nausea; nervousness; sinus inflammation; sore or dry throat; tremor; trouble sleeping; vomiting. Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; ear pain; fast or irregular heartbeat; new or worsened trouble breathing; pounding in the chest; red, swollen, blistered, or peeling skin; severe headache or dizziness; unusual hoarseness; wheezing.

Pulmicort - rash, contact dermatitis, urticaria, angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety and psychosis. neck pain, abdominal pain, dry mouth, vomiting, weight gain, insomnia, infection, taste perversion

Symbicort - Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death, psychiatric symptoms, e.g., irritability, anxiety, restlessness, nervousness, agitation, depression; skin bruising. immediate hypersensitivity reactions, such as anaphylactic reaction and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts, psychiatric symptoms, including aggressive reactions, behavioral disturbances, psychosis.
confusion; insomnia; seizures. dry hair; dry skin; urticaria; rash; pruritus; purpura; photosensitivity; increased sweating; alopecia, erythema multiforme, Conjunctivitis, dysphonia; blurred vision; earache; eye pain; blepharospasm; altered taste, Dry mouth; abdominal pain; anorexia; increased appetite and weight gain; nausea; vomiting; diarrhea; constipation; flatulence; gastritis; dyspepsia; thirst; hiccough; stomatitis. Urinary discoloration; altered micturition; menstrual irregularities; impotence; vaginitis; urinary retention; urinary incontinence; breast enlargement, Wheezing; upper respiratory tract infection; nasal dryness; pharyngitis; epistaxis; nasal congestion; dyspnea; coughing; rhinitis; hemoptysis; sinusitis; sneezing; bronchospasm; bronchitis; laryngitis. Breast pain; arthralgia; myalgia; malaise; chest pain; leg cramps; asthenia; back pain; fever; peripheral edema

I am a 57 year old man, who has been suffering from asthma several years. This spring my doctor put me on Singulair as an additional medicine to my cortisone-inhalator. after one month I feel symptoms of depression an mood-changing, severe ups and downs.
AND - as an additional symptom i have partially lost my feeling in some fingertips, and now parts of my left thumb and even a feeling of "cold2, mostly in my left hand.
anyone who share that symptom?
M.

If anyone has any access to databases that can describe the history of drug licensing in other countries and whether Merck had to amend product statements, this is worth investigating. I do know that montelukast was at least not initially licensed for seasonal allergies in the United Kingdom when the FDA granted approval in the US. As of 2006, seasonal allergies were not on the approved listed in the UK.

More to add to the files:

Safety of leukotriene antagonists
United Kingdom — The Medicines Control Agency
has published a review of adverse drug reactions to
a new class of asthma drugs, leukotriene antagonists.
Zafirlukast and moltelukast, competitive cysteinyl
leukotriene type-1 receptor antagonists, were
both marketed for the first time in 1998.
Cysteinyl leukotrienes are inflammatory mediators
and potent constrictors of bronchial smooth muscle
that attract human eosinophils and cause airway
oedema, mucus hypersecretion and reduced
mucociliary clearance. By blocking this action, leukotriene
antagonists can improve respiratory function
and lessen symptoms in patients with asthma.
The pharmacological action of leukotrienes is quite
complex and varying side effects have been
reported. Zafirlukast inhibits the hepatic cytochrome
P4502C9, and interacts with warfarin, theophyllin,
terfenadine, acetylsalicylic acid and erythromycin.
Montelukast is metabolized by hepatic cytochrome
P450CYP3A4 and co-administration of such drugs
as phenytoin, phenobarbitone and rifampicin, which
induce this enzyme, result in a marked reduction in
plasma levels.
Side-effects identified during clinical trials were
headache, abdominal pain, nausea, diarrhoea,
gastro-enteritis, influenza, pharyngitis, sinusitis,
cough, nasal congestion, dizziness, fatigue and insomnia.
Since marketing of montelukast, 173 reports
of 317 suspected adverse drug reactions
have been received in the United Kingdom. These
include oedema (50), psychiatric reactions, including
including agitation/restlessness (15), allergy, including
anaphylaxis, angioedema and urticaria (10), chest
pain (7), tremor (5), mouth dryness (5), vertigo (4)
and arthralgia (3).
Reference: Current Problems in Pharmacovigilance,
Volume 24, August 1998.
https://www.who.ch/druginformation/vol12/12-4.pdf

From a UK Yellow Card Report.

Montelukast

The product information for montelukast has been amended to include the following ADRs: Reaction No. of UK Yellow Card reports

Nausea 63 Diarrhoea 54 Rashes 52 Insomnia 44 Dizziness 42 Fatigue 37 Vomiting 24 Pruritus 24 Arthralgia 20 Urticaria 19 Malaise 18 Dyspepsia 13 Myalgia 12 Dry mouth 9 Anaphylaxis 4 Angioedema3

In addition, the following suspected ADRs have been reported and are still being evaluated: psychiatric disorders (63) ; also nightmares (13), sedation (13), palpitations (12), tremor (10) and increased sweating (10).
--------------------------------------------------------------------------------

Zafirlukast The most frequently reported ADRs under the Yellow Card Scheme for zafirlukast have been rashes (7), headache (7), abdominal pain (6), nausea (6) and pruritus (5). All of these are included in the product information which has also been updated to include the following ADRs that have been identified from data other than UK Yellow Card reports: urticaria, angioedema, blistering, bruising, bleeding disorders, including menorrhagia (rare), thrombocytopenia and agranulocytosis (both very rare). Churg-Strauss syndrome Churg-Strauss syndrome (CSS) is a rare syndrome characterised by a history of asthma, and often rhinitis and sinusitis, with systemic vasculitis and eosinophilia. There has been a recent increase in the number of reports of CSS associated with the use of anti-asthma drugs, particularly the leukotriene receptor antagonists. The MHRA/CSM have received 63 reports of CSS through the Yellow Card Scheme since 1963, 59 since the beginning of 1998; Of these, 90% were associated with drugs used to treat asthma (mainly leukotriene receptor antagonists). In many, but not all cases there was documented evidence of a reduction or withdrawal of oral corticosteroid therapy prior to the onset of the reaction. There are clear warnings regarding the possible association with CSS in the product information for montelukast and zafirlukast. Prescribers should be aware of the possibility that, although rare, CSS may be the underlying cause of asthma in their patients. In patients prescribed a leukotriene receptor antagonist prescribers should be alert to the development of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or peripheral neuropathy. The identification of new and suspected ADRs emphasises the important role of the Yellow Card Scheme in helping to ensure the safe use of medicines. The safety profile of leukotriene receptor antagonists remains under close review. Please continue to report all suspected ADRs to montelukast (Singulairt) and zafirlukast (Accolatet) through the Yellow Card Scheme.1. MHRA/CSM Current Problems in Pharmacovigilance 1998; 24:14.
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http://64.233.169.104/search?q=cache:3fU602hhlG8J:www.mhra.gov.uk/home/groups/pl-p/documents/publication/con2023236.pdf+montelukast+ADR&hl=en&ct=clnk&cd=10&gl=us

My 15 y.o. daughter has has first hand experience with weight gain on Advair. About 6 years ago at about 9 y.o., she gained 20 lbs in 6 months - and it started happening exactly when she started the drug. She was very active (swim team, gymnastics, etc) and did not overeat. It is very frustrating that both her pediatrician and her asthma/allergy specialist deny that her small dose of Advair is to blame.

For some reason, and I have talked to others that this has happened to, switching to Singulair did not help her with the weight problem. Seems the people who are hypersensitive to inhaled steroids are also sensitive to Singulair. Concerned about her rapid weight gain, and because she was always so thin, I took her to an endocrinologist to rule out any other problems. After a lot of bloodwork, he concluded that he could not rule out that it was a side effect of the Advair and/or Singulair, and that they may have elevated her blood sugar. I have read tons and tons of postings on the internet about children & adults rapidly gaining weight from inhaled corticosteroids (i.e. Flovent, Advair), along with the round face, bloated stomach, stretch marks, thin skin, easy bruising, etc. but nobody ever says what happens after stopping any of these drugs. Do people ever go back to normal? Do kids look like themselves again? Do any of the side effects disappear?

She is now 15 y.o. and cannot reverse her weight gain no matter what (30 lbs overweight). The last 2 years, she has only been on a small dose of Pulmicort (a different class of corticosteroid even safe to take when pregnant) since she has mild persistent asthma, and allergy shots have helped trememdously. My husband and I have been looking for 6 years now on how to avoid our daughter's weight gain with asthma drugs. If you run into any info., please let us know. Any experiences or info would be greatly appreciated. Thanks!

My daughter is 20 years old and a chronic asthmatic with severe allergies. She has been on Singulair for 8 years. She has been complaining and in some instances begging her asthma doctor for a reason for her insomnia and restless sleep over the last several years. She takes other asthma and allergy medications. He told her to not take her Xopenex inhaler before bed, as that may be causing the problem, that didn't help at all (sometimes a Xopenex nebulizer treatment is needed for her at bedtime and during the night, during asthma flair-ups). Her doctor just switched her from Allegra (which she has been on since she was 10) to Zyrtec, which is helping with allergies, but not with the sleeplessness. She was taken off of Advair and put on Symbicort in September 2007, this made her asthma worse requiring Prednisone off -and -on since January. She is back on Advair and doing better, but the sleepless nights continue...

We are seriously contemplating taking her off of the Singulair. We aren't 100% certain this medication is causing her insomnia/sleeplessness. However, as she explains it..."If I could get one really good nights sleep, I would go off of the Singulair in a heartbeat". Our fear is that by going off of the Singulair that her asthma will worsen.

I was on singulair for years for asthma. At first it seemed like a big help and I didn't put two and two together for a long time that it was causing problems. hair loss, weight gain, racing heart, rising blood pressure, dreams, irritability, memory loss, leg and muscle pain, and much more.
I have gone back to using theodur (theophylline) it has worked for 50 years for me and many others without the side effects of singulair.

Back in the 90's when the drug companies first started promoting all these new asthma drugs, especially the puffer$$, they got together and got the fda to take off the combo medicines that contain theophylline off the market, saying they 'didn't work'. So they removed marx, quadrinal, tedral, quibron and a host of others from the market...to clear the path to market their new designer asthma medicines. They almost got rid of theophylline too, but the pulmonologists put up a fight as it is one of their important meds. Theophylline is a terrific bronchial dialator. They also removed theophylline from primatene, an old standby over the counter medicine for asthmatics.

The reason they want rid of the theo and related drugs is because the patents have run out and they can't make any $money$ off them.

So welcome to the nightmare of singulair and others. Hope this little history helps.

My 12 y.o. daughter has has first hand experience with weight gain on Advair. About 3 years ago, she gained 20 lbs in 6 months - and it started happening exactly when she started the drug. She was very active (swim team, gymnastics, etc) and did not overeat. It is very frustrating that both her pediatrician and her asthma/allergy specialist deny that her small dose of advair is to blame. For some reason, and I have talked to others that this has happened to, switching to Singulair did not help her with the weight problem. Seems the people who are hypersensitive to inhaled steroids are also sensitive to Singulair.

Concerned about her weight, and because she was always so thin, I took her to an endocrinologist to rule out any other problems. After a lot of bloodwork, he concluded that he could not rule out that it was a side effect of the Advair, and that it may have elevated her blood sugar.

I have read tons and tons of postings on the internet about children & adults rapidly gaining weight from inhaled corticosteroids (i.e. Flovent, Advair), along with the round face, bloated stomach, stretch marks, thin skin, easy bruising, etc. but nobody ever says what happens after stopping any of these drugs. Do people ever go back to normal? Do kids look like themselves again? Do any of the side effects disappear? She's been off the Advair for about 6 months now (uses albuterol as needed) but cannot reverse her weight gain no matter what!

My husband and I have been looking for 3 years now on how to avoid our daughter's weight gain with asthma drugs. If you run into any info., please let us know. Any experiences or info would be greatly appreciated. Thanks!

I am new to asthma drugs, diagnosed with asthma in November at 44 years old. I hope that this helps someone else. I was put on Advair a few weeks ago. Along with Zithromax antibiotic to clear up the URI. Also was given Albuterol was severe breathing problems. The Albuterol helped of course (no sleeping though) and the antiobioitc as well as Advair seemed to get the problem under control in about a week. A few days after the anitibiotic was done, symptoms returned, but not as bad. Dr. put me on prednisone (the sterioid), and Advair. That was a hard week, but as before the symptoms improved. however, a few days after the prednisone course symptoms returned. The Dr. then decided to continue with the Advair, another longer course of prednisone and added Singulair to the mix. Within 3 days of taking the Singulair with the Advair, I could not sleep, had severe heart palpitations, wheezing, and the heartburn was so bad I felt like I had a huge stone in my chest and throat and several moderate asthmas incidents where I had to use the Albuterol. I had a headache, dizziness, and could not sleep. The Singulair MADE MY BREATHING PROBLEMS WORSE. And if you read the side effects of Singulair they actually can make worse the very asthma symptoms they are supposed to improve. It was a real eye opener. READ YOUR PATIENT INSERT FROM THE PACKAGE. I felt like I was going to die and each day felt worse. I discontinued the Singular after 4 days and within 24 hours felt much better and in 48 hourss had none of these syjmptoms. My doctor was just incredulous that this MIRACLE drug THAT MOST PEOPLE NEVER, EVER HAVE problems with could bother me. Drs try but you know your body better than anyone else, dont' be shy and stand your ground, they are wrong sometimes!!So listen to your head and heart, and body and read the labels. I had to figure this out for myself. On to the next part of the story, I am on Advair now for about 8 weeks, and notice in the past week, I am light headed, dizzy sometimes, am not sleeping a sound sleep, waking every hour or so, am NERVOUS AND JUMPY, my legs and arms are so weak, I can barely walk, so so tired, I feel like I am just slipping away. It is hard to type this because my fingers are so shakey and weak. Thank goodness I found this web site. I am discontinuing the Advair, I know in my gut that after reading this and listening to that little voice in my head that I am sensitve to a lot of drugs anjd Advair is on of them. It might be 1-3% of the people tested that have these awful side effects, but it doewsn't seem such a small group if you are one of them. And if you look at the studies, they only test around 400 people!!! So my journey continues. I am not totally convinced I even have asthma..............Please email if you would like.