COPD Drug, Striverdi Respimat, Receives FDA Approval

[Jeannine]

COPD Drug, Striverdi Respimat, Receives FDA Approval

http://www.theglobaldispatch.com/copd-drug-striverdi-respimat-receives-fda-approval-29907/

Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time.

COPD is a serious lung disease that makes breathing difficult and worsens over time. Symptoms can include wheezing, cough, chest tightness, and shortness of breath. Cigarette smoking is the leading cause of COPD. According to the National Heart, Lung, and Blood Institute, COPD is the third leading cause of death in the United States.

“The availability of this new long-term maintenance medication provides an additional treatment options for the millions of Americans who suffer with COPD,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Striverdi Respimat is a long-acting beta-adrenergic agonist (LABA) that helps the muscles around the airways in the lungs stay relaxed to prevent symptoms. The safety and effectiveness of Striverdi Respimat was evaluated in 3,104 people diagnosed with COPD. People who received Striverdi Respimat showed improved lung function compared to placebo.

The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and effectiveness of Striverdi Respimat in people with asthma has not been established and it is not approved to treat asthma. Striverdi Respimat should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm).

Striverdi Respimat should not be used in patients with acutely deteriorating COPD and may cause serious side effects, including narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects.

The FDA approved Striverdi Respimat with a patient medication guide that includes instructions for use and information about the potential risks of taking the drug.

The most common side effects reported by people using Striverdi Respimat in the clinical study were nasopharyngitis (runny nose), upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain and arthralgia (joint pain).

Striverdi Respimat is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.

 

[barbara]

The most common side effects reported by people using Striverdi Respimat in the clinical study were nasopharyngitis (runny nose), upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain and arthralgia (joint pain).

Add the box warnings (those are indeed scary) and you have to wonder how the FDA approves of these types of medications and yet denies us access to a simple medical procedure using our own stem cells. Then again, I don't have to wonder. It's all about the money.

 

[Donna]

Is anyone really impressed that people who received Striverdi Respimat showed improved lung function compared to placebo? Is that like saying I feel less hungry when I eat as compared to when I don't eat? And it's pretty bad when the box has to have warnings printed on it. It's no wonder that FDA approved medications are killing so many people.

 

[Jeannine]

That is pretty much what most of these new drugs seem to do. They are compared to a placebo and deemed better than that Then we are charged ridiculous prices.

Is anyone really impressed that people who received Striverdi Respimat showed improved lung function compared to placebo? Is that like saying I feel less hungry when I eat as compared to when I don't eat? And it's pretty bad when the box has to have warnings printed on it. It's no wonder that FDA approved medications are killing so many people.

 

[barbara]

The box warning should state, "Clinical trials have shown that this medication may or may not be better than a poke in the eye".

Recently, Dr. Centeno posted a challenging article on his website. He asks if we should take the evidence based zealots and put them all in a randomized controlled trial of the parachute. Funny thing is, this was actually a real proposed study meant to poke fun of the seriousness of these zealots. I wonder if any of them saw the humor in it. The conclusions are priceless.


http://www.regenexx.com/2014/08/has-medical-research-become-faith-based-religion/

Conclusions As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.