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Asthma Meds Likely Safe During Pregnancy: Study

Posted 20 Jan 2012 by Drugs.com

FRIDAY, Jan. 20 – A new study found no statistically significant link between asthma medication use during pregnancy and common birth defects. However, the study did find a positive association between some rare birth defects and mothers with asthma, and potentially with their medication use. But, the researchers couldn't tease out whether the problem was a loss of oxygen from less than well-controlled asthma or an effect of medications. "Worsening asthma is a risk to the mom and the fetus. Hypoxia (a lack of oxygen) we know is a problem for a developing fetus. And, the potential risk they found here is very small. Even if it turns out to be a true increase, the risk is so small. This study raises more questions than it answers," said Dr. Natalie Meirowitz, chief of the division of maternal fetal medicine at Long Island Jewish Medical Center in New Hyde Park, N.Y. What's most ... Read more

Related support groups: Asthma, Albuterol, Symbicort, Asthma -- Maintenance, Spiriva, Fluticasone, Advair Diskus, Combivent, Qvar, Asthma -- Acute, Epinephrine, Flovent, Ventolin, ProAir HFA, Xopenex

New Guidelines for Spotting, Treating COPD Released

Posted 1 Aug 2011 by Drugs.com

MONDAY, Aug. 1 – Four of the world's leading pulmonary associations have issued new guidelines for the diagnosis and treatment of chronic obstructive pulmonary disease, one of the world's leading killers. While the recommendations are based on more recent studies of the disorder, they differ little from previous guidelines and are meant largely to emphasize how critical it is to manage the disease to reduce hospitalizations, exacerbations and deaths, said lead author Dr. Amir Qaseem, director of clinical policy in the medical education division of the American College of Physicians, one of the four sponsoring organizations. "We're repeating the message. Chronic obstructive pulmonary disease is the third leading cause of death and . . . the number keeps going up. In 2007, it was the fifth leading cause of death," said Qaseem. "Many patients are still not getting the appropriate care." ... Read more

Related support groups: Chronic Obstructive Pulmonary Disease, Albuterol, Spiriva, Triamcinolone, Fluticasone, Qvar, Epinephrine, Flovent, Ventolin, ProAir HFA, Xopenex, Entocort, Mometasone, Budesonide, Ipratropium

Researchers Question Safety of Mist Inhalers for Delivering Common Drug for Chronic Lung Disease

Posted 15 Jun 2011 by Drugs.com

BALTIMORE, June 14, 2011 - People who use a mist inhaler to deliver a drug widely prescribed in more than 55 countries to treat chronic obstructive pulmonary disease (COPD) may be 52 percent more likely to die, new Johns Hopkins-led research suggests. The findings, published by BMJ, the British medical journal, raise concerns not only about the mist inhaler — a device that delivers the soluble form of the medication tiotropium — but also about the drug itself. The mist inhaler has not yet gained regulatory approval in the United States, but the drug in its powdered form is commonly used to treat COPD here. “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,” says Sonal Singh, M.D., M.P.H., an assistant professor of general internal medicine at the Johns Hopkins University Sc ... Read more

Related support groups: Chronic Obstructive Pulmonary Disease, Spiriva, Spiriva HandiHaler, Tiotropium

COPD Drug Via Mist Inhaler Could Raise Death Risk: Study

Posted 14 Jun 2011 by Drugs.com

TUESDAY, June 14 – A mist inhaler with the drug Spiriva is associated with a 52 percent increased risk of death among people with chronic obstructive pulmonary disease (COPD), a new review shows. The mist inhaler with the soluble form of Spiriva (tiotropium) is approved in 55 countries, but is not yet approved in the United States. However, the powdered form of Spiriva is commonly used to treat COPD patients in the United States. "Tiotropium is an inhaled drug used commonly in the treatment of COPD. Its major purpose is to reduce obstruction to airflow," explained Dr. Mark Rosen, director of pulmonary rehabilitation at North Shore University Hospital in Manhasset, N.Y., and Long Island Jewish Medical Center in New Hyde Park, N.Y. "In the U.S., it is available only in the 'Handihaler' device that delivers the drug in a powder form," said Rosen, who was not involved in the new study. ... Read more

Related support groups: Chronic Obstructive Pulmonary Disease, Spiriva

Certain COPD Meds Linked to Urinary Troubles in Men

Posted 24 May 2011 by Drugs.com

MONDAY, May 23 – New research suggests that a certain class of drugs used to treat chronic obstructive pulmonary disease (COPD) boosts the risk that male patients will be unable to urinate. The disease, which makes breathing difficult due to inflammation and blockage in the body's air passages, affects an estimated 10 percent of people aged 40 and older. A class of drugs called "inhaled anticholinergic" medications are used to treat the conditions, but there are concerns about their side effects. These drugs include tiotropium (Spiriva), ipratropium bromide (brand name Atrovent) or Combivent, which is ipratropium combined with albuterol. In the new Canadian study, Dr. Anne Stephenson of St. Michael's Hospital in Toronto and colleagues examined medical records from people in Ontario, aged 66 and older, who suffered from chronic obstructive pulmonary disease. Of the more than 565,000 ... Read more

Related support groups: Chronic Obstructive Pulmonary Disease, Spiriva, Combivent, Ipratropium, Atrovent, Spiriva HandiHaler, Tiotropium, DuoNeb, Atrovent HFA, Albuterol/Ipratropium

For Lung Disorder, Spiriva Beat Serevent in Head-to-Head Trial

Posted 24 Mar 2011 by Drugs.com

WEDNESDAY, March 23 – People with moderate-to-severe chronic obstructive pulmonary disease (COPD) use inhaled long-acting bronchodilators to control symptoms and reduce flare-ups, but which type of drug is best hasn't been clear. Now results have arrived from a new study that pitted two different popular COPD drugs against each other to determine their effectiveness at controlling the disease, which interferes with the flow of air through the lungs and airways. One of the drugs was tiotropium (Spiriva), an anticholinergic, and the other was salmeterol (Serevent), a beta-agonist. The outcome of the trial suggests that Spiriva is more effective at preventing flare-ups, also called exacerbations. "Prevention of exacerbations is a critical treatment goal in the care of COPD patients due to the [illness and death] attributed to exacerbations," said lead study author Dr. Claus Vogelmeier, ... Read more

Related support groups: Chronic Obstructive Pulmonary Disease, Spiriva, Chronic Obstructive Pulmonary Disease, Maintenance, Serevent Diskus

Early Trial Suggests COPD Drug Might Help Some Asthmatics

Posted 19 Sep 2010 by Drugs.com

SUNDAY, Sept. 19 – For asthma patients whose condition is not controlled with standard inhaled steroids, the addition of Spiriva – a medication already approved for lung disease – appears to improve breathing, a new study finds. However, the study authors and an outside expert stressed that these are early findings and much longer, larger clinical trials are needed. Tiotropium bromide (Spiriva)) belongs to a class of drugs called anticholinergics, which work by enlarging the airways to allow for easier breathing. Currently, the U.S. Food and Drug Administration has only approved the medication for use by patients with chronic obstructive pulmonary disease (COPD), a chronic ailment that is a combination of bronchitis and emphysema. Treating asthma has never been a one-size-fits-all proposition, so "having a new class of asthma medications could be potentially important," said lead ... Read more

Related support groups: Asthma, Spiriva

Leading COPD Drug Won't Harm Heart: FDA

Posted 15 Jan 2010 by Drugs.com

THURSDAY, Jan. 14 – The U.S. Food and Drug Administration on Thursday said it found no good evidence that the Spiriva HandiHaler boosts heart risks in patients who use it to help control chronic obstructive pulmonary disease (COPD). The announcement comes after data released in early 2008 by the drug's maker, "suggesting a small increased risk of stroke in patients treated with tiotropium [Spiriva], the medicine's active ingredient," the FDA noted in a statement. In October of 2008, the agency released an "Updated Early Communication" that pointed to two other studies suggesting a boost in risk of stroke, heart attack and death among users of the Spiriva HandiHaler. But a study published in the January 2010 issue of Chest found the opposite: that tiotropium might lower users' risk of heart problems and death. Spiriva is one of the most commonly prescribed daily treatments for COPD, a ... Read more

Related support groups: Chronic Obstructive Pulmonary Disease, Spiriva, Spiriva HandiHaler

Leading COPD Drug May Raise Chances of Heart Trouble

Posted 7 Jan 2010 by Drugs.com

THURSDAY, Jan. 7 – New research suggests that the drug ipratropium bromide (Atrovent), used widely among patients who have chronic obstructive pulmonary disease (COPD), may raise the risk of heart attack and heart failure, while a separate study of the COPD drug tiotropium (Spiriva) shows it may well lower the risk of heart problems and death. The inhaled medications are the most commonly prescribed daily treatments for COPD, a respiratory illness that's the fourth-largest killer in the United States. The two studies are published in the January issue of Chest. "The short-acting form [Atrovent] seems to increase cardiovascular risk, while the long-acting form [Spiriva] seems to decrease it," said Dr. Norman H. Edelman, chief medical officer of the American Lung Association. "It is important to point out, however, that the difference is an indirect inference," he added. "To prove beyond ... Read more

Related support groups: Chronic Obstructive Pulmonary Disease, Spiriva, Ipratropium, Atrovent, Spiriva HandiHaler, Tiotropium, Atrovent HFA

FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations

Posted 20 Dec 2009 by Drugs.com

RIDGEFIELD, Conn. & NEW YORK--(BUSINESS WIRE)--Dec 17, 2009 - Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Spiriva HandiHaler (tiotropium bromide inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD). Spiriva HandiHaler is already FDA-approved as a once-daily maintenance treatment for breathing problems associated with COPD, which includes chronic bronchitis, emphysema, or both. Reducing exacerbations is a key goal of COPD disease management, according to treatment guidelines. In the clinical trials that served as the basis for this approval, COPD exacerbations were defined as a new onset or increase of symptoms (including cough, sputum, wheezing or difficulty breathing) lasting for at least three days and which required a change in ... Read more

Related support groups: Chronic Obstructive Pulmonary Disease, Spiriva, Chronic Obstructive Pulmonary Disease, Maintenance, Chronic Obstructive Pulmonary Disease, Acute, Spiriva HandiHaler

FDA Medwatch Alert: Tiotropium (marketed as Spiriva HandiHaler)

Posted 7 Oct 2008 by Drugs.com

[UPDATE 10/07/2008] FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes.FDA expects to receive the complete report for UPLIFT in November 2008.  Results from this trial will also help to address some issues raised about tiotropium in the two recent ... Read more

Related support groups: Spiriva, Spiriva HandiHaler

Spiriva Safe, Effective for COPD Patients

Posted 5 Oct 2008 by Drugs.com

SUNDAY, Oct. 5 – For patients suffering from chronic obstructive pulmonary disease (COPD), tiotropium (Spiriva) improves lung function and quality of life but does not significantly slow progression of the disease, a new study finds. Spiriva and a similar drug, Atrovent, are the most commonly prescribed once-daily treatments for COPD, a respiratory illness that's the fourth largest killer in the United States. Recently, studies have associated these medications with a 58 percent increased risk of heart attack, stroke and other cardiovascular problems. "We found that patient-centered outcomes such as health-related quality of life, exacerbations, and even mortality were better in the treated versus the control group," said study co-author Dr. Bartolome R. Celli, chief of pulmonary care at St. Elizabeth's Medical Center in Boston. "In addition, there were no increased numbers of ... Read more

Related support groups: Spiriva, Spiriva HandiHaler

Leading COPD Drugs Tied to Stroke, Heart Attack

Posted 23 Sep 2008 by Drugs.com

TUESDAY, Sept. 23 – Common drugs prescribed for chronic obstructive pulmonary disease (COPD) are associated with an increased risk of heart attack, stroke and other cardiovascular problems, researchers report. These inhaled anticholinergic agents, such as Spiriva and Atrovent, are the most commonly prescribed once-daily treatment for COPD, a respiratory illness that's the fourth largest killer in the United States. "We found a 58 percent increased risk of cardiac death, heart attack or stroke," in people taking these drugs, said Dr. Sonal Singh, assistant professor of internal medicine at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. "In absolute terms, what it means is that if you were to use these drugs for a year, your absolute risk of developing an additional cardiac death would be one in 40." Singh was lead author of a paper published in the Sept. 24 issue ... Read more

Related support groups: Chronic Obstructive Pulmonary Disease, Spiriva, Atrovent, Spiriva HandiHaler, Atrovent HFA

FDA Medwatch Alert: Tiotropium (marketed as Spiriva HandiHaler)

Posted 18 Mar 2008 by Drugs.com

[Posted 03/18/2008] Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”).  Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period. It is important to ... Read more

Related support groups: Spiriva, Spiriva HandiHaler

FDA Medwatch Alert: Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) Capsules

Posted 29 Feb 2008 by Drugs.com

[Posted 02/29/2008] FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules. FDA and the American Association of Poison Control Center’s (AAPCC) National Poison Data System have received many reports of patients swallowing Spiriva and Foradil capsules rather than placing the capsules in the inhalation devices. Both products are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease and bronchitis. Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. See the Public ... Read more

Related support groups: Spiriva, Spiriva HandiHaler, Foradil Aerolizer

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