| |
RECENT CASES |
|
| |
|
|
| |
 |
|
| |
|
|
| |
GENERAL INFORMATION |
|
| |
|
|
| |
 |
|
| |
|
|
|
| |
FDA Directs ADHD Drug Manufacturers to Notify
Patients about Cardiovascular Adverse Events
and Psychiatric Adverse Events |
|
| The U.S. Food and Drug
Administration (FDA) today 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. |
| "Medicines approved
for the treatment of ADHD have real benefits for
many patients but they may have serious risks as
well," said Steven Galson, M.D., Director,
Center for Drug Evaluation and Research (CDER). "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 and in developing new Patient
Medication Guides to better inform doctors and
patients about these concerns." |
| Patient Medication Guides
are handouts given to patients, families and caregivers
when a medicine is dispensed. The guides contain
FDA-approved patient information that could help
prevent serious adverse events. Patients being
treated with ADHD products should read the information
before taking the medication and talk to their
doctors if they have any questions or concerns. |
| ADHD is a condition that
affects approximately 3 percent to 7 percent of
school-aged children and approximately 4 percent
of adults. The three main symptoms are inattention,
hyperactivity, and impulsivity. People with ADHD
may have difficulty in school, troubled relationships
with family and peers, and low self-esteem. |
| An FDA review of reports
of serious cardiovascular adverse events in patients
taking usual doses of ADHD products revealed reports
of sudden death in patients with underlying serious
heart problems or defects, and reports of stroke
and heart attack in adults with certain risk factors. |
| Another FDA review of
ADHD medicines revealed a slight increased risk
(about 1 per 1,000) for drug-related psychiatric
adverse events, such as hearing voices, becoming
suspicious for no reason, or becoming manic, even
in patients who did not have previous psychiatric
problems. |
| FDA recommends that children,
adolescents, or adults who are being considered
for treatment with ADHD drug products work with
their physician or other health care professional
to develop a treatment plan that includes a careful
health history and evaluation of current status,
particularly for cardiovascular and psychiatric
problems (including assessment for a family history
of such problems). |
| As part of the Agency’s
ongoing regulatory activity, in May 2006 the FDA
directed manufacturers of these products to revise
product labeling for doctors to reflect concerns
about adverse cardiovascular and psychiatric events.
These changes were based on recommendations from
the FDA Pediatric Advisory Committee and the Drug
Safety and Risk Management Advisory Committee.
To help patients understand these risks, an additional
part of this revised labeling process is the creation
of a Patient Medication Guide for each individual
product. |
| The medicines that are
the focus of the revised labeling and new Patient
Medication Guides include the following 15 products: |
- 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
|
| The draft Patient Medication
Guides for each product can be found at http://www.fda.gov/cder/drug/infopage/ADHD/default.htm.
For more information please visit www.fda.gov. |
|
|
| Trademark
Notice: Personal Injury Lawyer America is an electronic newsletter
from Lieff Cabraser Heimann & Bernstein, LLP. Lieff Cabraser
represents clients in a wide range of cases, including personal
injury and wrongful
death lawsuits. Our personal injury attorneys
| lawyers are committed to providing the very best representation
and support possible for our clients. This website provides information
on the legal rights of the injured and the latest news on product
defects and related lawsuits. |
Lieff Cabraser
is not affiliated in any way with any trademark owner. The use of
any trademarks on this site is for product identification and information
purposes only.
About Lieff Cabraser: We have
offices in San Francisco, New York and Nashville. Our lawyers have
represented clients in personal injury, wrongful death and
rollover crashes and product defect lawsuits across America, including
residents of Alaska, Alabama, Arkansas, Arizona, California,
Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho,
Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland,
Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North
Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada,
New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South
Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin,
West Virginia and Wyoming.
Among the cases our personal injury
attorneys are prosecuting are the Medtronic heart lead recall, the
AMO contact lens solution recall, the Peter Pan peanut butter recall, Guidant
pacemaker defects, SUV
rollover accidents, popcorn
workers lung injuries, and Ford
switch fires.
Disclaimer: The hiring of legal
professionals is an important decision that should not be based on
advertising alone. Please read our disclaimer. |
|
| Copyright © 2008 Lieff Cabraser Heimann & Bernstein, LLP |
|
|
|