Ellie was admitted at 2 weeks of age due to a severe cough though it was most likely due to aspiration pneumonia than CF-related (or, complicated by CF). She has seldom coughed since that time. We started her on Pulmozyme last October due to "changes" in her chest rads - though not accompanied by a cough, nor has she cultured anything other than staph. Her doctor stated that the "changes" could be reversed if we started Pulmozyme. She hasn't had any adverse affects to speak of.
Lack of long-term studies essentially equates to the fact that the FDA approved the drug based upon sufficient data and didn't require further long-term data. I feel that there are indeed long-term studies - they have/are being conducted simply by the fact that patients have taken the drug for the past 10+ years without further required labeling on the product (i.e., long-term use has proven safe, overall).
Children under 5 are generally unable to perform the necessary breathing tests in order to achieve accurate test results...thus they weren't used for the studies. I don't think there is any particular reason for lack of data in this area other than for that reason....
Lack of long-term studies essentially equates to the fact that the FDA approved the drug based upon sufficient data and didn't require further long-term data. I feel that there are indeed long-term studies - they have/are being conducted simply by the fact that patients have taken the drug for the past 10+ years without further required labeling on the product (i.e., long-term use has proven safe, overall).
Children under 5 are generally unable to perform the necessary breathing tests in order to achieve accurate test results...thus they weren't used for the studies. I don't think there is any particular reason for lack of data in this area other than for that reason....