View Full Version : Need advice.

09-25-09, 06:52 PM
My son intially was diagnosis last Spring with PDD-NOS, our pedatric OT recommended that we get another evaluation for him, and not is diagnosis with ADHD with no autism at all. He is only 5 and, he prescribed Focalin XR. I read in their website and the Prescribing info that children under the age of 5 should not be given. Then I wonder why he prescribe it and is it safe to give it to him. Is it safe for his age so should wait until he turns 6 or older?

09-25-09, 11:57 PM
The drug company is obligated to provide specific information about the clinical trials they used to develop the drug and prove it is effective, safe, and of use to patients and providers. A lot of times, the trials used to prove this, in order to initially gain approval for marketing from the FDA, are not broad in terms of the age and race of study participants. The companies can, however, go back to the FDA with data supporting the use of their drug in additional age populations, with the added bonus of extending their patent rights.

What I'm getting at, is the drug company cannot claim their drug is safe for an age population until they do additional clinical trials, submit an application to the FDA, and prove their drug is safe and effective in that specific population. A prescribing physician, on the other hand, is free to use their professional judgement and skills to decide what medication is the most likely to be effective and beneficial in treating their individual patients. This is commonly known as prescribing something "off-label." In fact, the majority of medication, prescription and non-prescription, are not officially FDA approved for use in children under 12, and even fewer are FDA approved for use in younger children.

Your doctor prescribed your son the Focalin XR because in his professional judgement, it will be an overall beneficial, and safe, part of his treatment for ADHD. If you are still concerned about the safety of Focalin XR, contact your doctor. Honestly, your questions could probably have been answered best by calling your doctor and asking him why he prescribed your child this medication. Ideally you would have already asked him this, before you accepted this prescription for your young child and left, but only experience brings this knowledge, and now you are prepared for the next time. Good luck to you and your son!:)

11-25-09, 02:21 AM
no kid should be on drugs, definitely not under 10

12-03-09, 09:09 PM
My doctor told me they never give XR medication to kids. She said they can only give it to adults. Might want to seek a second opinion.

12-28-09, 03:59 AM
I would ask to switch him to Focalin IR (immediate release). It has a short half life (4-6 hr.), and it can be prescribed in as low as 2.5 mg (the dosage may go up to 20 mg.)

I hope this helps.

12-29-09, 06:19 PM
My son in on Focalin XR and he's 6. I've not seen any bad side effects besides staying up later and less appetite. He's on much more than 5mg, his psych feels that it's much safer for younger kids of this age.