FDA to Adress drug safety issues Feb 9-10: Review ADHD Drugs' Link to Death, Hea

[Guest guest]

FDA to Adress drug safety issues Feb 9-10: Review ADHD Drugs' Link to

Death, Heart Attacks

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

FYI

ADHD is a controversial diagnosis for which there is no consensus

among chilod psychiatrists and pediatricians--inasmuch as there is no

demonstrable abnormailty in children

who are labelled ADHD. Abnormalities may arise after they have taken

psychostimulants--such as Ritalin, Adderall, Concerta or the

antidepressant, Strattera for a period of time.

However the drugs also have lethal effects with short term use.

Children, especially, but adults also, who have been prescribed these

drugss are at increased risks of death:

some have succumbed to " sudden death " , others have had heart attacks

and strokes.

These lethal consequences can no longer be swept under the carpet.

The FDA has announced a public hearing about

" 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 meeting is scheduled for February 9 in Gaithersburg, land.

The following day, the same committee will discuss FDA's actions on

painkillers and risk-management programs for the acne drug, Accutane.

We note that public comments on Feb. 10 are scheduled at a most

inconvenient time--8:15 A.M.--9:15 A.M.--a time necessitating the

expenditure of an overnight stay.

Clearly the FDA is doing its best to keep the public at bay.

***It is important that such meetings include representatives for

consumer safety -- such representatives must be free of any financial

ties to pharmaceutical companies.

Unfortunately, without the necessary financial resources it is not

possible for AHRP to speak up at such meetings.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

Drug Safety and Risk Management Advisory Committee

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

Agenda:

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 Ferretti-

Aceto at least 7 days in advance of the meeting.

Contact Person:

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@...

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.

horizonal rule

ADD Drugs' Link to Deaths, Heart Attacks Gets Review

2006-01-03

By Kerry Dooley Young

Jan. 3 (Bloomberg) -- Sudden deaths, heart attacks and strokes

in people taking attention deficit disorder drugs have

led U.S. regulators to seek advice on how to study the medications'

potential risk.

The Food and Drug Administration asked its standing committee of

risk-management advisers to review reports of

heart-related complications in children and adults using the

medicines, the agency's Web site said. The biggest makers of the

drugs are & and Shire Plc, with combined quarterly

sales of their products topping $300 million.

U.S. and Canadian regulators have been looking in the past few

years at the potential heart risk of attention-deficit

drugs, which are stimulants used to improve concentration.

Health Canada in August allowed Shire to resumes sales in that nation

of its Adderall attention-deficit drug, which earlier had

been suspended on heart concerns.

``I will suspect Adderall will be part of the discussion'' at

the FDA's Feb. 9 meeting, said Matt Cabrey, a spokesman for

Basingstoke, England-based Shire.

The FDA's posting did not list which drugs the meeting will

cover. About 2 million American children have the disorder,

which causes restlessness and difficulty concentrating, according to

the U.S. National Institutes of Health's Web site.

`Work With FDA'

& will work with the FDA as it considers these

risks, said Kathy Fallon, a company spokeswoman. Concerta

is a once-daily form of Ritalin, a generic medicine that a parent

company of Novartis AG pioneered in the 1950s. Adderall

contains amphetamine. Both medicines are known to cause heart

problems, according to the NIH's Web site.

Irregular heart beat is a ``rare'' complication of Eli Lilly &

Co.'s Strattera attention-deficit drug, which is not a

stimulant, the NIH's Web site said. Officials at Indianapolis-based

Lilly cannot tell from the FDA's posting whether its

medicine will be included at the meeting, Lilly spokeswoman

Bunselmeyer said.

Lilly anticipates that the FDA this year will ask a panel of

advisers to consider the psychiatric risks of the drugs,

Bunselmeyer said. Lilly in September said there had been ``uncommon''

reports of people having suicidal thoughts while

taking Strattera.

The meeting on attention-deficit drugs and heart risk will be in

Gaithersburg, land. The few long-term studies done on

ADD drugs have provided little information on heart risks, the agency

said. The same committee will discuss the FDA's actions on Feb.

10 on painkillers and risk-management programs for Roche Holding AG's

Accutane acne drug and its generic versions, according to

the agency's posting.

The disorder's official name is Attention Deficit Hyperactivity

Disorder, often shortened to ADHD or simply ADD.

The symptoms fall into categories of impulsivity, inattention and

hyperactivity, although not all patients suffer from the

hyperactivity component.

--Editors: Simison (jto)

Story illustration: To learn more about ADD, see

http://www.nimh.nih.gov/healthinformation/adhdmenu.cfm

To contact the reporter on this story:

Kerry Dooley Young in Washington (1)(202) 624-1936 or

kdooley@...

To contact the editor responsible for this story:

Simison at (1)(202) 624-1812 or

rsimison@...

FAIR USE NOTICE: This may contain copyrighted (© ) material the use

of which has not always been specifically authorized by the copyright

owner. Such material is made available for educational purposes, to

advance understanding of human rights, democracy, scientific, moral,

ethical, and social justice issues, etc. It is believed that this

constitutes a 'fair use' of any such copyrighted material as provided

for in Title 17 U.S.C. section 107 of the US Copyright Law. This

material is distributed without profit.

[Guest guest]

FDA to Adress drug safety issues Feb 9-10: Review ADHD Drugs' Link to

Death, Heart Attacks

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

FYI

ADHD is a controversial diagnosis for which there is no consensus

among chilod psychiatrists and pediatricians--inasmuch as there is no

demonstrable abnormailty in children

who are labelled ADHD. Abnormalities may arise after they have taken

psychostimulants--such as Ritalin, Adderall, Concerta or the

antidepressant, Strattera for a period of time.

However the drugs also have lethal effects with short term use.

Children, especially, but adults also, who have been prescribed these

drugss are at increased risks of death:

some have succumbed to " sudden death " , others have had heart attacks

and strokes.

These lethal consequences can no longer be swept under the carpet.

The FDA has announced a public hearing about

" 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 meeting is scheduled for February 9 in Gaithersburg, land.

The following day, the same committee will discuss FDA's actions on

painkillers and risk-management programs for the acne drug, Accutane.

We note that public comments on Feb. 10 are scheduled at a most

inconvenient time--8:15 A.M.--9:15 A.M.--a time necessitating the

expenditure of an overnight stay.

Clearly the FDA is doing its best to keep the public at bay.

***It is important that such meetings include representatives for

consumer safety -- such representatives must be free of any financial

ties to pharmaceutical companies.

Unfortunately, without the necessary financial resources it is not

possible for AHRP to speak up at such meetings.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

Drug Safety and Risk Management Advisory Committee

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

Agenda:

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 Ferretti-

Aceto at least 7 days in advance of the meeting.

Contact Person:

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@...

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.

horizonal rule

ADD Drugs' Link to Deaths, Heart Attacks Gets Review

2006-01-03

By Kerry Dooley Young

Jan. 3 (Bloomberg) -- Sudden deaths, heart attacks and strokes

in people taking attention deficit disorder drugs have

led U.S. regulators to seek advice on how to study the medications'

potential risk.

The Food and Drug Administration asked its standing committee of

risk-management advisers to review reports of

heart-related complications in children and adults using the

medicines, the agency's Web site said. The biggest makers of the

drugs are & and Shire Plc, with combined quarterly

sales of their products topping $300 million.

U.S. and Canadian regulators have been looking in the past few

years at the potential heart risk of attention-deficit

drugs, which are stimulants used to improve concentration.

Health Canada in August allowed Shire to resumes sales in that nation

of its Adderall attention-deficit drug, which earlier had

been suspended on heart concerns.

``I will suspect Adderall will be part of the discussion'' at

the FDA's Feb. 9 meeting, said Matt Cabrey, a spokesman for

Basingstoke, England-based Shire.

The FDA's posting did not list which drugs the meeting will

cover. About 2 million American children have the disorder,

which causes restlessness and difficulty concentrating, according to

the U.S. National Institutes of Health's Web site.

`Work With FDA'

& will work with the FDA as it considers these

risks, said Kathy Fallon, a company spokeswoman. Concerta

is a once-daily form of Ritalin, a generic medicine that a parent

company of Novartis AG pioneered in the 1950s. Adderall

contains amphetamine. Both medicines are known to cause heart

problems, according to the NIH's Web site.

Irregular heart beat is a ``rare'' complication of Eli Lilly &

Co.'s Strattera attention-deficit drug, which is not a

stimulant, the NIH's Web site said. Officials at Indianapolis-based

Lilly cannot tell from the FDA's posting whether its

medicine will be included at the meeting, Lilly spokeswoman

Bunselmeyer said.

Lilly anticipates that the FDA this year will ask a panel of

advisers to consider the psychiatric risks of the drugs,

Bunselmeyer said. Lilly in September said there had been ``uncommon''

reports of people having suicidal thoughts while

taking Strattera.

The meeting on attention-deficit drugs and heart risk will be in

Gaithersburg, land. The few long-term studies done on

ADD drugs have provided little information on heart risks, the agency

said. The same committee will discuss the FDA's actions on Feb.

10 on painkillers and risk-management programs for Roche Holding AG's

Accutane acne drug and its generic versions, according to

the agency's posting.

The disorder's official name is Attention Deficit Hyperactivity

Disorder, often shortened to ADHD or simply ADD.

The symptoms fall into categories of impulsivity, inattention and

hyperactivity, although not all patients suffer from the

hyperactivity component.

--Editors: Simison (jto)

Story illustration: To learn more about ADD, see

http://www.nimh.nih.gov/healthinformation/adhdmenu.cfm

To contact the reporter on this story:

Kerry Dooley Young in Washington (1)(202) 624-1936 or

kdooley@...

To contact the editor responsible for this story:

Simison at (1)(202) 624-1812 or

rsimison@...

FAIR USE NOTICE: This may contain copyrighted (© ) material the use

of which has not always been specifically authorized by the copyright

owner. Such material is made available for educational purposes, to

advance understanding of human rights, democracy, scientific, moral,

ethical, and social justice issues, etc. It is believed that this

constitutes a 'fair use' of any such copyrighted material as provided

for in Title 17 U.S.C. section 107 of the US Copyright Law. This

material is distributed without profit.