PFIMR filed a petition with the FDA on October 16, 2011 asking the FDA to revoke its approval of roflumilast for the treatment of COPD. The FDA website lists several of the documents related to the approval process. There are excellent summaries of the clinical trials conducted. The FDA staff doctors, who wrote these summaries, voted against giving approval to roflumilast. They noted that this medicine has a lot of serious side effects and the benefits are marginal at best. Dr. Anthony G. Durmowicz, M.D. of the FDA wrote, “The overall rate of moderate or severe exacerbations was reduced by 0.24 per patient year with a reduction of 0.21 for moderate (use of corticosteroids) and 0.03 for severe (hospitalization) exacerbations. Thus for an individual COPD patient treated with roflumilast, it would potentially take five years of therapy to get the benefit of not having to receive one 10-14 day course of corticosteroids..”
The side effects of roflumilast are common and sometimes very serious. The incidence of intractable diarrhea, acute pancreatitis, suicides, and cancers was higher in the roflumilast group as compared to the placebo group. There was a statistically significant increase in the incidence of prostate, lung, and colo-rectal cancers in the roflumilast group.
The advisory committee convened by the FDA, voted 10 to 5, against giving approval to roflumilast. Advisory committee members pointed out that inhaled steroids are universally used in severe COPD and there was no data to suggest that the addition of roflumilast improved outcome in these patients. The committee members suggested that roflumilast should be tried in patients already taking inhaled steroids before they could decide if roflumilast was safe and effective.
The FDA went ahead and approved roflumilast without any further testing or comments. This is not good news for the patients of COPD. Now the drug company will go ahead with a marketing campaign to get as many of the patients on roflumilast as possible, even though scientific research shows that risk/benefit ratio is not in favor of roflumilast.
Please click here to see the petition filed with the FDA.