The FDA advises that the manufacturers must now provide Patient Medication Guides outlining potential risks and precautions for the use of these various ADHD drugs. These guides are provided through the pharmacy when a prescription is filled.
"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," according to Steven Galson, M.D., director of the Center for Drug Evaluation and Research.
"In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling ... to better inform doctors and patients about these concerns," adds Galson.
These guides contain patient information approved by the FDA that may prevent serious side effects.
Patients and caretakers are advised to carefully read the information before taking the medication and discuss any questions or concerns with their doctors.
The FDA reviewed the reports of patients taking the ADHD products on a regular basis and determined that reports of sudden deaths in some patients were linked to unknown and underlying serious heart problems or defects, among other health-related risk factors.
The ADHD condition affects about three to seven percent of children who are school-aged and about four percent of adults.
Symptoms of ADHD include the inability to stay on task, hyperactivity and impulsive behaviors. Difficulties in school, strained abilities to handle relationships with family and friends, and low self-esteem are also usually prevalent in patients with ADHD.
The risk of adverse psychiatric events with patients taking the ADHD medicines was reported to be only a slight increase of approximately 1 in 1,000, according to the FDA. The risk for adverse cardiovascular events was not provided.
However, the FDA advises all patients and doctors to include a full medical and prior family history assessment before providing ADHD medications.
To date, the revised product labeling directive of the FDA will affect the following 15 products:
1. Adderall tablets
2. Adderall XR extended-release capsules
3. Concerta extended-release tablets
4. Daytrana Transdermal System
5. Desoxyn tablets
6. Dexedrine Spansule capsules and tablets
7. Focalin tablets
8. Focalin XR extended-release capsules
9. Metadate CD extended-release capsules
10. Methylin oral solution
11. Methylin chewable tablets
12. Ritalin tablets
13. Ritalin SR (sustained-release) tablets
14. Ritalin LA extended-release capsules
15. Strattera capsules
For further information visit the FDA's website at www.fda.gov.
