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More on ADD/ADHD/LD Case Studies Medical Endorsements Program Benefits |
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Phone:
647.439.8416
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Medical News
Cases of sudden death and serious adverse events including hypertension, myocardial infarction, and stroke have been reported to the agency in association with therapeutic doses of drugs used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and adult populations. The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks.
On February 9, 2006, the committee will be asked to discuss approaches that could be used to study whether these products increase the risk of adverse cardiovascular outcomes.
On February 10, 2006, the committee will be briefed on developments in the Office of Drug Safety and will receive updates on the Drug Safety Oversight Board and agency actions for the COX-2 selective Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and the risk management program for the isotretinoin products.
Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).
Procedure:
Interested persons may present data, information, or views, orally
or in writing, on issues pending before the committee. Written
submissions may be made to the contact person by February 2, 2006.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on February 9, 2006, and between
approximately 8:15 a.m. and 9:15 a.m. on February 10, 2006. Time
allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person
before February 2, 2006, and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names
and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation. Persons
attending FDA's advisory committee meetings are advised that the
agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Victoria
Ferretti-Aceto at least 7 days in advance of the meeting.
| CDER |
February 9, 2006 February 10, 2006 |
8:00
a.m. - 5:00 p.m. 8:00 a.m. - 3:00 p.m. |
Holiday Inn Gaithersburg Two Montgomery Village Ave. Gaithersburg, MD |
Contact Person:
Victoria Ferretti-Aceto, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail:
ferrettiV@cder.fda.gov
Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information
on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512535.
Direct link: http://www.fda.gov/oc/advisory/accalendar/2006/cder12535dd02091006.html
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