According to new research, Spiriva mist inhalers may increase the risk of dying by up to 52 percent. The increased risk was shown to occur in patients who used the Spiriva Respimat inhaler, which delivers a soluble form of the drug known generically as tiotropium. Spiriva inhalers are used to treat chronic obstructive pulmonary disease (COPD), which is the fourth leading cause of death worldwide.
What’s the problem?
June 15, 2011 - The new study, which was published in the British Medical Journal (BMJ), was based on a meta-analysis of five clinical trials involving some 6,500 test subjects. It found that the risk of unexpected death in individuals using the Respimat inhaler was 52 percent higher than in patients who were treated with a placebo.
"We estimate that there will be one additional death for every 124 patients treated for a year with tiotropium Respimat," Dr. Yoon Loke of Norwich Medical School at the University of East Anglia, who worked on the study, said in a statement.
The inhaler is approved for use in Europe and Great Britain, but was denied by the U.S. FDA after it received information linking tiotropium to an abnormally high number of deaths.
Although the link between Spiriva and unexpected deaths is still not fully understood, a growing number of medical experts believe it is because of an increased dose of tiotropium. "What we think is going on is that the mist inhaler is delivering a higher concentration of tiotropium than it should be and that may be increasing the risk of death," Dr. Sonal Singh of Johns Hopkins University School of Medicine, who led the study, said in a statement. Individuals at highest risk seem to be those dying of heart trouble, especially for those with existing heart problems that may be made worse with the use of Spiriva.
The new research on Spiriva is likely to have a negative impact on sales, and could greatly benefit GlaxoSmithKline’s rival product Advair. That, in turn, may offset the looming threat of generic competition to Advair in non-U.S. markets. A copycat version of the drug was recently approved in Sweden. In 2010, more than 500,000 Spiriva prescriptions were written for COPD sufferers in Britain alone.
Spiriva is typically prescribed to prevent wheezing, shortness of breath, and difficult breathing in individuals with COPD. It is in a class of medications called bronchodilators that work by relaxing and opening the air passages to the lungs to make breathing easier. Spiriva is available in several different forms:
- as a powder (Spiriva, Boehringer Ingelheim and Pfizer);
- delivered via a Handihaler device (Boehringer Ingelheim and Pfizer);
- in mist form delivered via the Respimat Soft Mist Inhaler (Boehringer Ingelheim and Pfizer), which is recommended for patients with poor manual dexterity.
Stop using Spiriva and seek immediate medical attention if you notice any of the following side effects:
- difficulty breathing
- swelling of the face, lips, tongue or throat
- tongue swelling or redness
- sores or white patches in the mouth, lips, or tongue
- urinating less than usual
- dry mouth
FDA Warning on Spiriva HandiHaler
The Spiriva HandiHaler was approved by the FDA in 2004, and is used by millions of people with emphysema and bronchitis. Along with its cousin Atrovent, Spiriva is used once or more daily to relax muscles and open airways in a patient’s lungs. At the time of approval, all indications were that both of these products were beneficial for the purposes of opening a patient's lungs and facilitating breathing. However, in March 2008, the FDA issued a press release warning the public about an increased risk of stroke associated with the Spiriva HandiHaler. According to the announcement, a meta-analysis of 39 trials found that individuals treated with Spiriva for over a year faced an increased risk of certain side effects, including stoke. Data reviewed for 13,500 patients with COPD indicated that approximately eight out of every 1,000 individuals suffered a stroke side effect, compared with six out of every 1,000 who suffered a stroke while taking a placebo.
If You Are Taking Spiriva
Before taking Spiriva, tell your doctor if you are allergic to atropine or its derivatives (such as ipratropium or oxitropium), or if you have any other allergies. Spiriva may contain inactive ingredients which can cause allergic reactions and other problems. Additionally, tell your doctor if you have a family medical history of any of the following issues:
- glaucoma (narrow-angle)
- prostate enlargement (BPH or cancer)
- difficulty urinating
- severe kidney disease