Spiriva Handihaler May Increase Risk of Heart Attacks, Stroke or Death
Published: September 24th, 2008 • Comments: 17
According to research published today in the Journal of the American Medical Association, those using the Spiriva Handihaler or an older generic inhaler called ipratropium, could face an increased risk of cardiac death, heart attacks or strokes when compared with those who received a placebo or other drugs.
Spiriva Handihaler (tiotropium) is an inhaled medication made by Boehringer Ingelheim Pharmaceuticals Inc. and jointly marketed by Boehringer and Pfizer Inc. in the U.S. It was approved in 2004 as a once-daily long-term treatment of bronchospasm linked with chronic obstructive pulmonary disease (COPD).
Ipratropium is the generic name for Atrovent, which is also manufactured by Boehringer. It was approved in 1998 for treatment of COPD.
Both medications are anti-cholinergics that work by opening passages for effective breathing and preventing spasms that narrow airways in the lungs. They have been used by a combined 8 million people worldwide.
A new study published in the September 24, 2008 issue of JAMA suggests that although the risks were small, the popular inhalers could be linked to serious and potentially life threatening side effects.
Researchers analyzed data from 17 randomized studies, comparing mainly older people on either drug to those on placebos or other drugs. It was found that patients on Spiriva or ipratropium had a 58% higher risk of developing heart problems, both fatal and nonfatal, including heart attacks.
Out of 7,400 patients using Spiriva Handihaler or ipratropium, 1.8% developed heart problems, compared with 1.2% of the 7,300 users who received other drugs or placebos. This could mean that one extra drug-linked death could be caused by ipratropium and Spiriva side effects for every 40 patients using either of the two drugs for one year.
Researchers indicate that additional studies are necessary to fully evaluate the safety of the drugs. However, they did suggest that individuals with COPD should try to reduce heart risks by stopping smoking, controlling blood pressure and cholesterol and using oxygen before starting drug therapy.
Boehringer and Pfizer have released a statement that they strongly disagree with the analysis of the new study. They indicate that an analysis of 30 clinical trials confirmed that Spiriva Handihaler is safe to use and that there is no increased risk of all-cause death or cardiovascular death
In March 2008, the FDA issued an early communication indicating that they are evaluating a possible connection between side effects of Spiriva Handihaler and an increased risk of strokes. At that time, the drug regulator agency indicated that their investigation does not mean that there is a causal relationship between Spiriva and strokes, and that individuals should not stop taking their drug based on their early communication.
The FDA has not updated their early communication from March, which indicated that the would announce any conclusions and recommendations to the public later this year.
Comment by Alex on 24 September 2008:
i started taking Spiriva in late 2005; by late 2006 the rapid heart palpitations began. It happened while i slept, while i worked, while i did nothing at all. at one point i was fearful that a heart attack was imminent.
When i stopped taking the spiriva, the palpitations stopped! i was examined by a cardiologist who discovered that the left side of my heart has thickened and as a result of that i now have a blood pressure issue. from time to time i have palpitations but im taking medicine to control that.
I believe ALL OF MY HEART ISSUES WERE CAUSED BY SPIRIVA!!!
i believe that my lifespan has been compromised by the drug SPRIVA.
Comment by Jim on 24 September 2008:
I have been taking Spiriva for about 18 months for COPD associated with scarring from dermotomyositis. I had a 2 heart attacks on Sept. 21, 2008. I don’t know if there is a connection to the use of Spiriva and the Myocardial Infarctions.
Comment by Boyce on 28 September 2008:
I am have a cardiomyopathy condition and I am a Spriva “patient” to deal with COPD. I will be in contact with my physicians in Monday, 9-29.
Comment by Thomas on 30 September 2008:
I have been inhaling Spiriva for a year or so once a day and a few days ago my doc noticed that I had atrial fibrulation. I am 83 years old and am a typical elderly person who were part of the case study on spiriva – in which JAMA reported that there was nearly a 60% increase in fatal and non-fatal cardiac events. I am conflicted as to what to do about my Spiriva. Breathing easier is a nice thing but death is pretty final.
Comment by Judy on 7 October 2008:
I have only been using Spiriva since the first of August 2008 but it makes me wonder if I should continue, I have high cholesterol but no history of heart problems and I really don’t want any. There is a history of heart problems in my family. I do like the idea of breathing better but almost feel like I could still live without it; I am really having a problem making a decision.
Pingback by FDA Updates Early Communication about Spiriva HandiHaler Side Effects : AboutLawsuits.com on 8 October 2008:
[...] which emerged last month after two separate reports were published by independent researchers about Spiriva side effects which could increase the risk of heart attacks, strokes and death. One of those studies involved an analysis of combined data from 17 clinical trials with nearly [...]
Comment by Margaret on 18 December 2008:
My dad had a problem with high blood pressure for a short amount of time that he got under control by changing his diet. He also had an extra heartbeat. Other than that, he had no heart problems that we were aware of. He went to the doctors and was prescribed this medicine for bronchitis and possibly COPD. He died three days later from a heart attack at age 53!
Comment by Margaret on 5 March 2009:
I have taken Spiriva for nearly 8 months i suffer from Asthma and COPD since taken this medication i feel i have no relieve from taking Spiriva, now i suffer high blood pressure and believe Spiriva has caused this
Comment by Penny on 19 May 2009:
Judy: Do no use Spriva!!!!! The studies that show it as a very risky drug are valid; read them and you’ll see they are done by reputable concerns. Sounds like you have a choice. I’d like to breathe better, also, and have been using Spriva, but will never use it again. I looked up problems with it because I had such terrific problems from the use of Levaquin and finally learned from a website much like this one, that all the problems were coming from the Levaquin. I’m so thankful we have these websites!!
Comment by Linda on 9 October 2009:
I have been taking Spiriva for almost 2 months. I have experienced
rapid heart beat. I am being treated for asthma. I will be seeing a cardiologist on Tuesday. I feel this medicine is unsafe.
Comment by Suzane on 27 November 2009:
PLEASE PLEASE PLEASE……..if you are taking SPIRIVA, stop!!!!!! My mom died of a heart attack here at home on Oct 19, 2009 after taking spiriva for the last 2 1/2 years. Prior to this, she had no heart conditions and was pretty normal but still had COPD. She used to swim every day and was very active but since taking this drug i saw her become less active and winded at the sligthest activity and and started to get heart palpitations and developed atrial fibrillation as well. She also conplained of chest pains and tightening in her throat aftger taking spiriva at times. The night she died, she was fine that day and active. She was in bed and my dad reminded her that she had to take her meds (spiriva and advair) and did them for her and within a few minutes of taking spiriva she had a heart attack there in bed. I strongly believe that Spiriva was the cause of this. I had to say something after reading these posts becuase i feel that Spiriva took my mom from me!!!!!!!!!!!!
Comment by Steve on 30 November 2009:
I started taking Spiriva in the spring of 2009. My breathing seemed to improve somewhat, but by September 2009 I began to have episodes of sleep apnea where I awoke not breathing with heart palpitations. Now, in November I have had several events awake or at the threshold of sleep with disturbing heart arrhythmia and/or palpitations.
I have experienced my heart “skipping a beat” from time to time in the past, but nothing that comes close to this. I stopped taking Spiriva for about a month, with no real negative change in my breathing, but the palpitations and sleep apnea continue.
I am not a doctor but cannot help but attribute (or suspect) my condition to the prescribed Spiriva. I do not take any other drugs.
My doctor wants me back on Spiriva, but I must say reading these other posts together with my empirical experience and the Sept 2008 warning of a link to heart attacks and strokes with this drug convince me otherwise.
Comment by oweta on 28 December 2009:
i have been on spiriva for over three years.it has effected my eyes and my bladder.now i have very high blood pressure after having low all my life.i have just been dionosed with left ventricle hyperthropy. it is a very bad med.
Comment by charlie on 15 January 2010:
i have been on spiriva for just three months.it has effected my eyes and my bladder. i almost died my legs were swelling and i had fluid everywhere i started seeing things and talking to dead relatives. i went to my doctors office! my blood pressure was 48/29 thought it was a mistake took it again it was lower it dropped to 65/1 called the ambulance just made it I.C.U. 3days hospital for 3 more. my release paper said i had renal failure do to spiriva!
SHOULD I SUE?
Pingback by Spiriva HandiHaler Not Linked to Risk of Stroke, Heart Attack, Death: FDA - AboutLawsuits.com on 18 January 2010:
[...] users may face a slight increase in the risk of stroke when compared to the use of a placebo. A subsequent study in October 2008 suggested that usrs may also face an increased risk of heart attack and death, in [...]
Comment by CHARLES on 11 May 2010:
i have been on spiriva for just three months.it has effected my eyes and my bladder. i almost died my legs were swelling and i had fluid everywhere i started seeing things and talking to dead relatives. i went to my doctors office! my blood pressure was 48/29 thought it was a mistake took it again it was lower it dropped to 65/1 called the ambulance just made it I.C.U. 3days hospital for 3 more. my release paper said i had renal failure do to spiriva!
Comment by Dee on 25 June 2010:
I too have been taking spiriva for about 3 months. I started having stabbing pains in my chest and back. Didn’t think much of it but had some strange things going on with my heart, It seemed to be vibrating and “tripping”. I felt as though a stroke or heart attack was imminent.
Had my blood pressure checked and it was high . This scared me so I stopped taking the spiriva and hopefully, I caught it in time and it will soon be “normal” 120/60.