Drug Manufacturers to Notify Patients about heart and mental problems from ADHD drugs

[Guest guest]

After a year of foot dragging.....

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

FOR IMMEDIATE RELEASE

P07-26

February 21, 2007

Media Inquiries:

Sandy Walsh, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

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 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.

[Guest guest]

After a year of foot dragging.....

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

FOR IMMEDIATE RELEASE

P07-26

February 21, 2007

Media Inquiries:

Sandy Walsh, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

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 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.

[Guest guest]

After a year of foot dragging.....

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

FOR IMMEDIATE RELEASE

P07-26

February 21, 2007

Media Inquiries:

Sandy Walsh, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

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 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.

[Guest guest]

After a year of foot dragging.....

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

FOR IMMEDIATE RELEASE

P07-26

February 21, 2007

Media Inquiries:

Sandy Walsh, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

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 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.

[Guest guest]

Just 1 in 1000 for a psychiatric disorder, unbelievable, these researchers.

Marc

Jim <mofunnow@...> wrote:

After a year of foot dragging.....

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

FOR IMMEDIATE RELEASE

P07-26

February 21, 2007

Media Inquiries:

Sandy Walsh, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

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 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.

[Guest guest]

Just 1 in 1000 for a psychiatric disorder, unbelievable, these researchers.

Marc

Jim <mofunnow@...> wrote:

After a year of foot dragging.....

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

FOR IMMEDIATE RELEASE

P07-26

February 21, 2007

Media Inquiries:

Sandy Walsh, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

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 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.

[Guest guest]

Just 1 in 1000 for a psychiatric disorder, unbelievable, these researchers.

Marc

Jim <mofunnow@...> wrote:

After a year of foot dragging.....

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

FOR IMMEDIATE RELEASE

P07-26

February 21, 2007

Media Inquiries:

Sandy Walsh, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

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 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.

[Guest guest]

Just 1 in 1000 for a psychiatric disorder, unbelievable, these researchers.

Marc

Jim <mofunnow@...> wrote:

After a year of foot dragging.....

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

FOR IMMEDIATE RELEASE

P07-26

February 21, 2007

Media Inquiries:

Sandy Walsh, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

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 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.