FDA Has Concerns About ADHD Medications
On February 21, 2007, the U.S. Food and Drug Administration (FDA) 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.
The FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about the serious risks associated with the use of the following drugs:
· Adderall (mixed salts of a single entity amphetamine product) Tablets
· Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
· Concerta (methylphenidate hydrochloride) Extended-Release Tablets
· Daytrana (methylphenidate) Transdermal System
· Desoxyn (methamphetamine HCl) Tablets
· Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
· Focalin (dexmethylphenidate hydrochloride) Tablets
· Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
· Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
· Methylin (methylphenidate hydrochloride) Oral Solution
· Methylin (methylphenidate hydrochloride) Chewable Tablets
· Ritalin (methylphenidate hydrochloride) Tablets
· Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
· Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
· Strattera (atomoxetine HCl) Capsules
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