_files/img_fdagov_font_adj_small.png "Decrease font size")
_files/img_fdagov_font_adj_medium.png "Return font size to normal")
_files/img_fdagov_font_adj_large.png "Increase font size")
_files/img_fdagov_hhs_masthead_logo_r.png "U.S. Department of Health and Human Services"){kind=logo}
_files/gov-fda-new-white-png.png "FDA, U.S. Food and Drug Administration")
Drugs
_files/img_fdagov_utility_icon_print.png "Print this page"){kind=icon}
_files/img_fdagov_utility_icon_share.png "Share this page"){kind=icon}
_files/img_fdagov_utility_icon_email.png "E-mail this page"){kind=icon}
FDA Asks Attention-Deficit Hyperactivity Disorder (ADHD) Drug Manufacturers to Develop Patient Medication Guides
FDA has directed the manufacturers of all drug products approved for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) to develop patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.
- FDA Press Release1 (issued February 21, 2007)
- Advisory Committee Transcripts
- Drug Safety and Risk Management Advisory Committee2, February 9, 2006
- Pediatric Advisory Committee3, March 22, 2006
Drugs
Note: This page links to PDF files which require the free Adobe Acrobat Reader4.
| Adderall (mixed salts of a single entity amphetamine product) Tablets | Medication Guide 5 | Label6 |
| Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules | Medication Guide7 | Label8 |
| Concerta (methylphenidate hydrochloride) Extended-Release Tablets | Medication Guide | Label9 |
| Daytrana (methylphenidate) Transdermal System | Medication Guide | Label10 |
| Desoxyn (methamphetamine hydrochloride) Tablets | Medication Guide | Label 11 |
| Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets | Medication Guide | Label12 |
| Focalin (dexmethylphenidate hydrochloride) Tablets | Medication Guide | Label13 |
| Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules | Medication Guide | Label14 |
| Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules | Medication Guide | Label15 |
| Methylin (methylphenidate hydrochloride) Oral Solution | Medication Guide16 | Label17 |
| Methylin (methylphenidate hydrochloride) Chewable Tablets | Medication Guide18 | Label19 |
| Ritalin (methylphenidate hydrochloride) Tablets | Medication Guide20 | Label21 |
| Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets | Medication Guide22 | Label23 |
| Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules | Medication Guide24 | Label25 |
| Strattera (atomoxetine hydrochloride) Capsules | Medication Guide26 | Label27 |
-
_files/fda-square-white-small.png "FDA Homepage")
_files/img_fdagov_footer_logo_usagov.png "USA.gov"){kind=logo}
_files/img_fdagov_footer_icon_email.png "Subscribe to E-mails"){kind=icon}
_files/img_fdagov_footer_icon_rss.png "Subscribe to RSS Feeds"){kind=icon}
_files/img_fdagov_footer_icon_twitter.png "Follow FDA on Twitter"){kind=icon}
_files/img_fdagov_ftr_icon_facebook.png "Follow FDA on Facebook"){kind=icon}
_files/img_fdagov_footer_icon_youtube.png "View FDA Videos"){kind=icon}
_files/img_fdagov_footer_icon_flickr.png "View FDA Photostream on Flickr"){kind=icon}
_files/img_fdagov_footer_hhslogo.png "U.S. Department of Health & Human Services")