The Food and Drug Administration has approved the use of the pill form of the drug roflumilast, called Daliresp, despite the fact that their advisory panel voted not to recommend it for public use in April 2010 because the unexceptional increase in lung function didn’t make up for the amount of adverse side effects. The drug is only for those with severe COPD (chronic obstructive pulmonary disease), and shouldn’t be used in mild cases or for sudden breathing problems.
Approval of the drug happened despite the fact that it has side effects including headache, nausea, dizziness, diarrhea, insomnia, back pain, decreased appetite, mood changes, sudden weight loss and risks of mental health problems. From an outside prospective, this could just be seen as further evidence that America has become a “pill happy” society, ready to try any drug that promises relief from a problem, even if it means we have to take ten more pills to make the side effects go away.
On the other hand though, the Food and Drug Administration said in a news release that roflumilast was safe and effective to use because it demonstrated well in two phase three clinical trials with over 1,500 participants over the age of 40.
Whether or not COPD patients try the drug out will unfortunately depend on how well their drug company markets it with colorful magazine ads and television commercial campaigns. We already see commercials for inhaled COPD treatments on television on a regular basis, so this new drug will have to find an effective way to compete with that and try to make Daliresp a household name.
The bashing of the money-making pharmaceutical market in the United States isn’t to say this new drug taken once a day won’t prove useful to COPD patients, though. The leading cause of COPD is previous cigarette smoking, which many sufferers of COPD began to do in their youth without the proper knowledge of what it would do to their future health. Whether or not this drug is widely adapted and gets recommendations from doctors remains to be seen, and ultimately the effectiveness of the drug in treating COPD’s symptoms that will determine its success or failure in the pharmaceutical market.
- Neeraj Shahane's blog
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