The debate on the black box warnings (placing the warning in a black box on the package vs. the warnings already in the package insert) has been going back and forth with conflicting recommendations. The labelling is part of the ongoing evaluation the FDA does on labelling review for all meds. This just happens to be Glaxo this time.
http://news.yahoo.com/s/nm/20060822/hl_nm/antidepressants_dc
This may start showing up all methylphenidate products including the patch. To put things into perspective, the death rate for children was 0.16 per million perscriptions and mostly appeared in people with underlying heart conditions. This figure is similar to the death rate of kids in the general population. http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4202B1_ 05_FDA-Tab05.pdf
My daughter had an ekg with her pre med workup to help rule out underlying heart defects.
I heard today that the FDA is putting more warnings on ritalin meds.. Do you think that includes the patch? How do I get my DR to do a heart check on my son? They say that there have been a few deaths because of the meds containging ritalin in adults and children and now I am worried about my son because the patch has worked so well. What do you think I should say to the DR and what kind of testing do you think they would do? Anyone else worried about it?The new black box warnings expected soon for Ritalin concern the risks of hallucinations and other behavioral problems ( http://www.dailymail.co.uk/pages/live/articles/health/health main.html?in_article_id=401801&in_page_id=1774 ). There are rumors that more warnings about the potential risk to the heart with abuse could be added.
I would imagine any dosage or delivery system for ritalin will be covered in the US.
Remember that the risk is for abusing the meds and for a small small group of kids with preexisting heart problems.
Ask about the EKG. The manufacturer and the AMA both highly recommend EKG and other routine tests of the cardiopulmonary health before giving stimulant medication. To not give the test even when there is no sign of trouble is in itself negligent in my books.
I would ask for this strongly. Also ask to get a referral to a child psychologist as a normal part of diagnosis. If you don't rule out things like thyroidism and metal poisoning with the MD and bipolar and other psychological disorders with a Psych then you may just be giving the meds for nothing.
I don't worry about these risks any more than I worry over taking penicillin for the allergy risk or the aspirin for the ulcer risk. If you don't already have a problem that the stim meds will aggravate then it's no problem. Taking the precautions is like keeping your eyes on the road when driving. Not taking them is like driving blindfolded.
belladonna1:
I had the same concerns when we made the decision to start my son on stims., but his ped. did an EKG just as Glen above suggested so my worries are put to rest. His ped. will redo the EKG in a year to be sure everything is still okay. The ped. told me that the warning is put on to protect the manufacturers in case something happens, but the chances are slim in a healthy child.
mars.